Podcasts about dexcom g7

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Best podcasts about dexcom g7

Latest podcast episodes about dexcom g7

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News...Tandem's new infusion set approved, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later May 16, 2025 7:14


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Tandem's new infusion set is approved, Dexcom G7 compatibility with the Omnipod 5 iPhone app announced, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Tandem gets FDA clearance for a new infusion set. The company shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won clearance for its SteadiSet Infusion Set. SteadiSet features an integrated inserter with a hidden needle designed for one-handed insertion. It received clearance to deliver insulin for up to three days of use. However, Tandem plans to submit a separate request to extend the indicated use time to up to seven days. It doesn't expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time. Many of us have been following this since Tandem acquired CapBio back in 2022.. it's been pretty hush hush – CapBio has never accepted my requests for interviews, so I'm excited to see this approval, mostly because my son really really needs it! https://www.drugdeliverybusiness.com/tandem-capbio-fda-clearance-insulin-infusion-set/ XX   Insulet just announced via an email to health care providers that Dexcom G7 compatibility with the Omnipod 5 iPhone app will be released IN THE COMING WEEKS! Great news for people with #t1d and XX Sernova announces positive interim data from its ongoing Phase 1/2 clinical trial in patients with T1D. this is their Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today Interim data from 12 patients with transplanted human donor islet cells show patients achieving insulin independence, islet cell engraftment in Cell Pouch, islet function, islet survival, improved glycemic control, improved patient reported quality of life (QOL) and improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. Improvement in patient outcomes was correlated with a cumulative increase in the quantity of transplanted islets. Based on these findings, the study is on track to meet its primary and secondary endpoints, and the confirmatory Cohort C is expected to initiate in H2 2025.   Clinical trials with iPSC islet-like clusters from Sernova's partner, Evotec, are anticipated to begin in 2026 after completion of Cohort C of the ongoing trial. These interim findings, with 8 of 12 patients achieving insulin independence so far, support the thesis that Sernova's high volume ten channel Cell Pouch, used in Cohort B, plus an optimised immune suppression regimen, has the potential to achieve insulin independence, without portal vein transplant, in our planned clinical trial with Evotec's high quality iPSC islet-like clusters. Measured HbA1c (a blood test that shows the average blood sugar levels over the past 2-3 months) in patients with Cell Pouch alone, showed that 9 of 12 patients had a reduced value within the American Diabetes Association (ADA) recommended range of

We Are T1D : Type 1 Diabetes
Freestyle Libre Fails, CGM Anxiety & Type 1 Tech Troubles (With Sassy Banter, Of Course)

We Are T1D : Type 1 Diabetes

Play Episode Listen Later May 10, 2025 30:55


This week on We Are T1D, Mike and Jack unpack the reality of living with unreliable diabetes tech — from Freestyle Libre sensor failures to the emotional stress of depending on CGMs that just don't work. After five sensor fails in six weeks, Mike's had enough, and he's not holding back.Also in this episode:⚠️ How sensor failures trigger CGM anxiety (and why warm-ups now feel like betting on luck)

Real-Time Real Talk by Dexcom
Type 2 Diabetes Management with CGM: Advanced Technologies & Treatments for Diabetes (ATTD) Conference

Real-Time Real Talk by Dexcom

Play Episode Listen Later May 6, 2025 39:36


How can Continuous Glucose Monitoring (CGM) help people with type 2 diabetes feel more empowered and in control of their health? Exploring compelling new research presented at the Advanced Technologies & Treatments for Diabetes (ATTD) conference is host Cher Pastore, MS, RD, CDCES, BC-ADM, and guest Sim Singh, Senior Director of Behavioral and Translational Science at Dexcom. Together, they unpack findings from a 30-day study of Dexcom G7 use in people with type 2 diabetes, including those not on insulin. The results show significant improvements in glucose tracking, behavioral shifts like better nutrition and increased physical activity, and enhanced metabolic health and confidence - especially among CGM-naive users. Sim also shares insights from a Canadian trial and discusses how CGM is transforming diabetes education, not only for patients but for endocrinologists and primary care providers as well. Whether it's supporting blood sugar monitoring, enabling personalized diabetes treatment, or simply helping people better understand their glucose patterns, this conversation highlights how CGM and biosensor technology are reshaping diabetes management - for people with type 1 diabetes, type 2 diabetes, and even prediabetes.

Diabetes Connections with Stacey Simms Type 1 Diabetes
G7 15-Day Approval: Dexcom's Jake Leach Answers Your Questions

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Apr 22, 2025 32:36


Dexcom G7 gets FDA approval for 15-day wear. It's in adults-only and should hit the market in the second half of this year. I'm talking to Chief Operating Officer Jake Leach about this newest advance for Dexcom, why they didn't go for pediatric approval, their partnership with sleep ring company Oura, what else is coming this year from Dexcom and I'm asking a lot of your questions. Read the offical Dexcom press release here This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Join us at an upcoming Moms' Night Out event! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. GLP-1 for T1D trials, Ozempic pill, Dexcom 15-day sensor, type 5 diabetes, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Apr 18, 2025 7:39


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Eli Lilly will start a lcinical trial for tirzepatide for people with type 1 diabetes, more details on Dexcom's 15 day G7 sensor, Ozepmic pill form tested, type 5 diabetes identified and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Our top story this week.. Eli Lilly takes the first steps toward getting tirzepatide approved for people with type 1 diabetes. Tirzepatide is sold under the brand names Mounjaro for type 2 and Zepbound for obesity. The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or are overweight. Participation in the study will last about 49 weeks. Official Title A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight This is a big deal because, even though many people with type 1 are able to get a prescription for tirzepatide, it's not approved for T1D and so insurers won't usually cover it.   https://clinicaltrials.gov/study/NCT06914895 XX The use of drugs like Ozempic, Wegovy and Zepbound in people with type 1 diabetes has risen sharply over the past decade, a new study finds, even though there's little information on the drugs' safety and effectiveness for the condition. The family of medications called GLP-1 receptor agonists includes drugs like Wegovy, Zepbound, Ozempic, Mounjaro and Victoza. But the clinical trials of these medications specifically excluded people with type 1 diabetes, who are dependent on the hormone insulin to survive because they can't make enough of their own. Drugmakers feared that using the GLP-1 medications with insulin might raise the chance of dangerously low blood sugar events, or hypoglycemia, and were unwilling to take the risk of studying them in people with type 1.   For the study, which was published last month in the journal Diabetes, Obesity, and Metabolism, researchers at Johns Hopkins University reviewed the medical records of more than 200,000 people with type 1 diabetes from 2008 to 2023. They grouped the data in three-year periods, starting with October 2008 to September 2011 and ending with October 2020 to September 2023. GLP-1 medication use spiked, as well. Among adults with the highest category of obesity, about 4% used GLP-1 medications in 2008, and 33% did by 2023 – an 800% increase. But these are anecdotal reports and may not reflect instances in which people have side effects or complications like low blood sugar, which can be life-threatening. But Shin says what's really needed is information from randomized, double-blinded studies, in which participants are followed forward in time and given either a drug or a placebo. https://www.cnn.com/2025/04/09/health/glp-1-type-1-diabetes-study/index.html   XX Later this month the FDA will conduct a final meeting regarding a new, investigational compound (sotagliflozin) soda-GLIFF-a-zin that has been shown to Improve QoL and Reduce Long-term Complications for people with type 1 diabetes (T1D). The patient advocacy group Taking Control of Your Diabetes (TCOYD.org) is working to inform the T1D community about sotagliflozin - and to encourage people to sign a Change.org petition directed towards FDA.  Last fall, the FDA declined to approve sotagliflozin due to concerns about a potential increased risk of diabetic ketoacidosis (DKA), despite this being a condition that people with T1D on insulin face and manage daily. While TCOYD respects FDA's caution, the group stands by T1D patients and their physicians who, as a team, balance risks and benefits every day. https://tcoyd.org/petition/ XX Dexcom receives FDA approval for it's G7 with 15 day wear. We have an interview with Chief Operating Officer Jake Leach coming up on Tuesday – we talk about the planned roll out of this sensor, what else has changed, and the fine print in the press release – it says    “A study was conducted to assess the sensor life where 73.9% of sensors lasted the full 15 days. When using the product per package labeling, approximately 26% of sensors may not last for the full 15 days.   https://investors.dexcom.com/news/news-details/2025/Dexcom-G7-15-Day-Receives-FDA-Clearance-the-Longest-Lasting-Wearable-and-Most-Accurate-CGM-System/default.aspx?utm_source=www.diabetech.info&utm_medium=referral&utm_campaign=dexcom-g7-15-day-sensor-gets-fda-cleared-but-will-it-actually-last-that-long   XX Glucotrack is joining something called  FORGETDIABETES bionic pancreas initiative, - this is an European Union project that aims to develop a long-term automated insulin delivery system for type 1 diabetes patients. Glucotrack's Continuous Blood Glucose Monitor (CBGM) will be integrated into the system to provide real-time glucose readings. The initiative's goal is to create a bionic invisible pancreas that eliminates the need for therapeutic actions and reduces psychological burden.   The architecture of BIP encompasses a ground-breaking, lifelong lasting implanted ip glucose nanosensor; a radically novel ip hormone delivery pump, with unique non-invasive hormone refill with a magnetic docking pill and non-invasive wireless battery recharge; an intelligent closed-loop hormone dosing algorithm, optimized for ip sensing and delivery, individualized, adaptive and equipped with advanced self-diagnostic algorithms.     Pump refilling through a weekly oral recyclable drug pill will free T1D subjects from the burden of pain and awkward daily measurement and treatment actions. Wireless power transfer and data transmission to cloud-based data management system round-up to a revolutionary treatment device for this incurable chronic disease. key feature of BIP is to be fully-implantable and life-long lasting thanks to novel biocompatible and immune-optimized coatings guaranteeing long-term safety and stability https://www.stocktitan.net/news/GCTK/glucotrack-to-participate-in-forgetdiabetes-a-prominent-european-cjjldjb0dq7h.html XX A newly recognised form of diabetes, called Type 5, was announced this week at the World Congress of Diabetes 2025. A global task force will investigate this less-understood condition, which differs from Type 1 and Type 2 diabetes. Type 5 diabetes affects people who are underweight, lack a family history of diabetes and do not show the typical symptoms of Type 1 or Type 2 diabetes. The condition was first observed in the 1960s and referred to as J-type diabetes, after being detected in Jamaica. It was classified by the World Health Organisation in 1985, but removed in 1998 due to lack of physiological evidence. At the time, experts believed it to be a misdiagnosed case of Type 1 or 2 diabetes. New research has since confirmed that Type 5 is different. https://economictimes.indiatimes.com/news/new-updates/a-new-type-of-diabetes-has-been-found-by-scientists-and-it-doesnt-show-the-typical-symptoms-of-type-1-or-type-2/articleshow/120276658.cms?from=mdr   XX Oral semaglutide cuts major heart risks in people with type 2 diabetes by 14%, offering a powerful pill-based option. A new clinical trial, co-led by endocrinologist and diabetes specialist John Buse, MD, PhD, and interventional cardiologist Matthew Cavender, MD, MPH, at the UNC School of Medicine, has demonstrated that the oral form of semaglutide significantly lowers the risk of cardiovascular events in individuals with type 2 diabetes, atherosclerotic cardiovascular disease, and/or chronic kidney disease. Results from the rather large, international trial were published in the New England Journal of Medicine and presented at the American College of Cardiology's Annual Scientific Session & Expo in Chicago, Illinois.     The effect of oral semaglutide on cardiovascular outcomes was consistent with other clinical trials involving injectable semaglutide, but more trials are needed to determine if one method may be more effective than the other at reducing major cardiovascular events. https://scitechdaily.com/new-pill-form-of-semaglutide-shows-major-benefits-for-people-with-diabetes/ XX April 14 (UPI) -- The U.S. Food and Drug Administration on Monday warned consumers and pharmacies that fake versions of Ozempic, a drug to treat Type 2 diabetes, have been found in the United States. Novo Nordisk, the Danish-headquartered manufacturer, informed the FDA on April 3 that counterfeit 1-milligram injections of semaglutide were being distributed outside its authorized supply chain. The FDA and Novo Nordisk are testing the fake products to identify whether they're safe. Patients are asked to obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for any signs of counterfeiting. People in possession of the fake product are urged to call Novo Nordisk customer care at 800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EDT and report it to the FDA's criminal activity division's website. Side effects can be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program (800-FDA-1088 or www.fda.gov/medwatch) as well as to Novo Nordisk, at 800-727-6500. https://www.upi.com/Health_News/2025/04/14/FDA-fake-Ozempic-drugs-Novo-Nordisk/6841744666854/ XX Can a digital lifestyle modification program reduce diabetes risk? A new study shows that the lifestyle intervention significantly reduced 10-year diabetes risk among prediabetics by nearly 46% and increased the diabetes remission rate, highlighting the importance of lifestyle changes. However, the study was not a randomized trial, and participation in the lifestyle intervention was voluntary, which may introduce selection bias. The study evaluated 133,764 adults, categorizing them as diabetic (7.5%), prediabetic (36.2%), and healthy (56.3%), based on fasting glucose and HbA1c levels. https://www.news-medical.net/news/20250414/Digital-lifestyle-program-cuts-diabetes-risk-by-4625-in-prediabetics-study-of-130k2b-adults-reveals.aspx XX Chrissy Teigan is speaking out about her son's type 1 diagnosis – teaming up with Sanofi to encourage people to screen early for Type 1 diabetes.   Teigen got a crash course in the risks of undiagnosed Type 1 diabetes when her 6-year-old son, Miles, was hospitalized with complications of the autoimmune disease last year. The family knew nothing about Type 1 diabetes when Miles was diagnosed during an unexpected medical emergency, Teigen said in a Tuesday announcement. “We were confused and scared when Miles was first diagnosed,” she said in a statement. “There is no doubt in my mind that knowing in advance would have made a positive impact for Miles, me, and our entire family. I want everyone to hear me when I say: stay proactive and talk to your doctor about getting yourself or your loved ones screened for type 1 diabetes today!”   Teigen shared her family's story in a two-minute video on ScreenForType1.com, a Sanofi website that discusses how to get screened for the condition. Miles' diagnosis made Teigen feel like she “went from a mom to a doctor overnight,” she said. That experience is why Teigen said she is “begging you: Do this one thing, and screen yourself and your family for Type 1 diabetes.” https://www.fiercepharma.com/marketing/sanofi-signs-chrissy-teigen-diabetes-screening-campaign XX Dr. Richard Bernstein – best known for his advocacy around low carb diets for people with diabetes – died this week at the age of 90. Born in 1934 in Brooklyn, New York, he was diagnosed with type 1 at age 12. In the 1970s he adapted a blood glucose monitor for home use and helped pioneer home glucose monitoring. He published multiple books on Diabetes including the #1 selling Diabetes book on Amazon.Com “Dr. Bernstein's Diabetes Solution: A Complete Guide to Achieving Normal Blood Sugars” and “Diabetes Type II: Living a Long, Healthy Life Through Blood Sugar Normalization”.  He practiced and saw patients right up until his death.

Real-Time Real Talk by Dexcom
How Dexcom G7 and Digital Health Partners Enhance Patient Engagement: Patient and Provider Discuss Gamifying Type 1 Diabetes Management with CGM

Real-Time Real Talk by Dexcom

Play Episode Listen Later Mar 31, 2025 43:01


Integrating glucose sensor Dexcom G7 with digital health apps like Happy Bob and Undermyfork is improving diabetes treatment decisions and patient engagement. Whether it's gamifying glucose tracking, uncovering personalized glucose patterns, or making real-time adjustments, these digital tools empower both patients and providers. Cher Pastore, MS, RD, CDCES, BC-ADM is joined by diabetes experts Jami Klein, BSN, RN, CDCES and Rachael Sood, RN, MSN, APRN, NP-C, CDCE to explore how apps like Happy Bob and Undermyfork integrate with Continuous Glucose Monitoring (CGM) to make tracking blood sugar levels more interactive and insightful. Rachael shares real-world experiences from her diabetes care clinic, demonstrating how CGM-driven insights help patients with Type 1 diabetes, Type 2 diabetes, and prediabetes make better-informed treatment decisions. Jami brings her personal perspective on using CGM and apps to optimize diabetes management, highlighting the role of glucose sensors, blood sugar monitoring, and biosensor technology in simplifying daily care.Together, they explore how diabetes technology is reshaping diabetes education, treatment, and metabolic health, and how digital health solutions are making a lasting impact in endocrinology and primary care. Brought to you by Dexcom https://www.dexcom.com/

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Mar 28, 2025 8:20


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Learning more about the FDA letter sent to Dexcom, news from ATTD including a bihormonal pump from a Dutch company, time in tight range update, more studies about using insulin and GLP-1 medications, eating chili to prevent gestational diabetes (really!) and more..  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Our top story this week: Dexcom Dive Brief: A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom's continuous glucose monitors. The FDA raised concerns with a design change to a component used in the resistance layer of Dexcom's sensors. The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company's response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note Tuesday that the letter concerns a chemical compound that the sensor wire is dipped in. Dexcom began producing the compound internally to add redundancy to its supply chain.   Dive Insight: Dexcom Chief Operating Officer Jake Leach said in an interview with MedTech Dive last week that the company does not expect the warning letter to affect future product approvals, including a 15-day version of its G7 CGM, and there's no need yet to recall products. Dexcom has submitted the device to the FDA and anticipates a launch in the second half of the year.   Marcus, after speaking to company leadership and a quality control expert, wrote that many of the issues outlined in the letter could be addressed quickly. He added that the warning letter could explain minor delays in approval to the 15-day sensor, but Dexcom is still within the 90-day window for a 510(k) submission.   “While there's always a risk this could impede future product approvals,” Marcus wrote, “we do not expect this to materially delay the 15 day G7 sensor approval.”   The warning letter followed an FDA inspection last year of Dexcom's facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510(k), Dexcom stopped in-sourcing the compound and reverted back to the external supplier.   Dexcom's devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors with the changed coating “cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions,” the letter said.     The FDA raised other concerns in the warning letter, including procedures to monitor the glucose and acetaminophen concentrations used in testing of the G6 and G7 CGMs. The FDA also cited problems with Dexcom's handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels. https://www.medtechdive.com/news/dexcom-warning-letter-cgm-coating-change/743597/ XX Lots of studies and info out of the recent ATTD conference. One highlight that has been sort of under the radar: a Dutch company has been using a Bihormonal fully closed-loop system for the treatment of type 1 diabetes in the real world. This is a company called Inreda (in-RAY-duh). The Inreda AP® is an automatic system (closed loop) and independently regulates the blood glucose level by administering insulin and glucagon. The AP5 is certified in Europe and is being used in multiple studies and projects. The AP®6 is currently under development. https://www.inredadiabetic.nl/en/discover-the-ap/ https://pubmed.ncbi.nlm.nih.gov/38443309/ XX Let's talk about time in tight range. If you follow me and diabetes connections on social, you likely saw a video I made about this – it blew up last week. If not.. time in range has been a metric for a short while now.. in 2019 there was a consensus report advising a goal of 70% of time in the 70-180 mg/dL range for most people with type 1 diabetes (T1D) and type 2 diabetes (T2D), with modifications for certain subgroups. Recently we've been hearing more about 70-140 mg/dL — for longer periods as “time in tight range (TiTR).” At ATTD there was more talk about calling that range TING, or “time in normal glycemia.     There's a great writeup that I'll link up from the great Miriam Tucker on Medscape about a debate that happened at ATTD. On March 22, 2025, two endocrinologists debated this question at the Advanced Technologies & Treatments for Diabetes (ATTD) 2025. Anders L. Carlson, MD, medical director of the International Diabetes Center (IDC), Minneapolis, took the positive side, while Jeremy Pettus, MD, assistant professor of medicine at the University of California San Diego, who lives with T1D himself, argued that it's too soon.   https://www.medscape.com/viewarticle/should-time-tight-range-be-primary-diabetes-goal-2025a100073q?form=fpf   XX Sequel Med Tech announces its twist pump will be firs paired with Abbott's FreeStyle Libre 3 Plus. The twist has FDA approval for ages 6 and up and is set to begin its commercial launch by the end of June. The pump—designed by inventor Dean Kamen's Deka Research & Development—also incorporates the FDA-cleared Tidepool Loop software program, to record CGM blood sugar readings, make predictions based on trends and adjust its background insulin levels accordingly. https://www.fiercebiotech.com/medtech/sequel-med-tech-connects-twiist-insulin-pump-abbotts-cgm-ahead-market-debut XX Dexcom's longer-lasting CGM sensor looks promising, based on study results presented at the conference. The trial showed that the new 15-day G7 system is slightly more accurate than the current G7. The accuracy of CGM can be measured using MARD (mean absolute relative difference), which shows the average amount a CGM sensor varies from your actual glucose levels (a lower number is better).  The 15-day G7 has a MARD value of 8.0%, about the same as the Abbott Freestyle Libre 3. The Dexcom G7 15 Day is awaiting FDA approval and is not yet available in the U.S.   XX Little bit of news from Modular Medical.. they plan to submit their patch pump to the FDA late summer or fall of this year. The MODD1 product, a 90-day patch pump, features new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe. It has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery. Modular Medical picked up FDA clearance for MODD1 in September. The company also raised $8 million to end 2024. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem's t:slim pump. By developing its patented insulin delivery technologies, the company hopes to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem's t:slim pump. https://www.drugdeliverybusiness.com/modular-medical-announces-12m-private-placement/ XX More from attd – type 2 news? https://www.drugdeliverybusiness.com/biggest-diabetes-tech-news-attd-2025/ XX Another study that says people with type 1 who use a GLP-1 medication get better outcomes. In this study, those who use GLP-1 with insulin are 55% less likely to have a hyperglycemia-related ED visit, 26% less likely to have an amputation-related visit, and 29% less likely to have a diabetic ketoacidosis (DKA)-related ED visit in the following year compared to those on insulin alone. Although they are not approved for T1D, some patients may receive them off-label or for weight control. Pretty big study for an off label drug: compared 7,010 adult patients with T1D who were prescribed GLP-1s and insulin to 304,422 adult patients with T1D who were on insulin alone.  It is important to note that the rates of new diabetic complications in one year for both groups were around 1%, indicating that these are uncommon outcomes regardless of medication use. https://www.epicresearch.org/articles/some-diabetic-complications-less-likely-among-type-1-diabetics-on-glp-1s   XX Early research here but exposure to antibiotics during a key developmental window in infancy may stunt the growth of insulin-producing cells in the pancreas and boost risk of diabetes later in life The study, is published this month in the journal Science, it's a study in mice. These researchers are working off the idea that when while identical twins share DNA that predisposes them to Type 1 diabetes, only one twin usually gets the disease. She explained that human babies are born with a small amount of pancreatic “beta cells,” the only cells in the body that produce insulin.   But some time in a baby's first year, a once-in-a-lifetime surge in beta cell growth occurs.   “If, for whatever reason, we don't undergo this event of expansion and proliferation, that can be a cause of diabetes,” Hill said.   They found that when they gave broad-spectrum antibiotics to mice during a specific window (the human equivalent of about 7 to 12 months of life), the mice developed fewer insulin producing cells, higher blood sugar levels, lower insulin levels and generally worse metabolic function in adulthood.   in other experiments, the scientists gave specific microbes to mice, and found that several they increased their production of beta cells and boosted insulin levels in the blood. When male mice that were genetically predisposed to Type 1 diabetes were colonized with the fungus in infancy, they developed diabetes less than 15% of the time. Males that didn't receive the fungus got diabetes 90% of the time. Even more promising, when researchers gave the fungus to adult mice whose insulin-producing cells had been killed off, those cells regenerated. Hill stresses that she is not “anti-antibiotics.” But she does imagine a day when doctors could give microbe-based drugs or supplements alongside antibiotics to replace the metabolism-supporting bugs they inadvertently kill.   .   “Historically we have interpreted germs as something we want to avoid, but we probably have way more beneficial microbes than pathogens,” she said. “By harnessing their power, we can do a lot to benefit human health.”     https://www.eurekalert.org/news-releases/1078112 XX Future watch for something called BeaGL - created by researchers at the University of California Davis and UC Davis Health who were inspired by their own personal experiences with managing T1D.   BeaGL is designed to work with CGMs and has security-focused machine learning algorithms to make predictive alerts about anticipated glucose changes, which are sent to a device. In this case, a smartwatch. The end goal is for BeaGL to be completely automated to reduce the cognitive load on the patient, particularly for teens. It's still in research phase but six student with T1D have been using it for almost a year.     https://health.ucdavis.edu/news/headlines/with-ai-a-new-metabolic-watchdog-takes-diabetes-care-from-burden-to-balance/2025/02 XX Investigators are searching for a way forward after two long-term diabetes programs were terminated following the cancellation of their National Institutes of Health (NIH) funding, the result of federal allegations that study coordinator Columbia University had inappropriately handled antisemitism on campus. The programs include the three-decades-old Diabetes Prevention Program (DPP) and its offshoot, the Diabetes Prevention Program Outcomes Study (DPPOS). “We are reeling,” said David Nathan, MD, a previous chair of both the DPP and the DPPOS and an original leader of the landmark Diabetes Control and Complications Trial. Nathan is also founder of the Massachusetts General Hospital Diabetes Center in Boston, one of the 30 DPPOS sites in 21 states. On March 7, the Trump administration cancelled $400 million in awards to Columbia University from various federal agencies. While Columbia University agreed on March 21 to changes in policies and procedures to respond to the Trump administration's charges, in the hopes that the funding would be restored, DPPOS Principal Investigator Jose Luchsinger, MD, told Medscape Medical News that as of press time, the study was still cancelled. https://www.medscape.com/viewarticle/diabetes-prevention-program-cancellation-colossal-waste-2025a100076h XX XX Type 2 diabetes may quietly alter the brain in ways that mimic early Alzheimer's. This was only an animal study – but researchers say the high comorbidity of type 2 diabetes (T2D) with psychiatric or neurodegenerative disorders points to a need for understanding what links these diseases.   https://scitechdaily.com/how-diabetes-quietly-rewires-the-brains-reward-and-memory-system/ XX Eating chili once a month when you're pregnant seems to lower the risk of developing gestational diabetes. This is a real study! While chili showed a link to lower gestational diabetes risk, dried beans and bean soup had no significant effect, even among women who ate them more frequently. Some studies suggest that diets high in beans and legumes, including the Mediterranean diet, reduce GDM risk. While studies link beans to lower diabetes risk, their specific impact on GDM remains unclear. This study analyzed data from 1,397 U.S. pregnant women who participated in the Infant Feeding Practices Study II, conducted between 2005 and 2007. Chili consumption varied significantly by race, education, household size, income, supplemental nutrition status, and region. Non-Hispanic Black mothers consumed the most (0.33 cups/week), while those with higher income and education levels consumed less. Regional differences also influenced chili intake. One possible mechanism for chili's effect is capsaicin, a bioactive compound found in chili peppers, which has been linked to metabolic benefits in other studies. However, further research is needed to confirm this potential role in GDM prevention. Dried bean and bean soup consumption had no clear association with GDM. The study highlights limitations due to self-reported dietary data and the need for more detailed dietary measures. https://www.news-medical.net/news/20250317/Could-a-little-spice-in-your-diet-prevent-gestational-diabetes.aspx XX

Real-Time Real Talk by Dexcom
Type 2 Diabetes Management Through Glucose Tracking: How CGM Improves Patient Outcomes

Real-Time Real Talk by Dexcom

Play Episode Listen Later Feb 26, 2025 39:28


Welcome back to another episode of Real-Time Real Talk where this week, host Cher Pastore is joined by Dr Thomas Grace and Dr. William Polonsky to discuss the power of Continuous Glucose Monitoring (CGM) in managing type 2 diabetes.Continuous Glucose Monitoring has revolutionized the management of diabetes. At its core, diabetes management is about balancing blood glucose levels to avoid the serious complications associated with hyperglycaemia and hypoglycaemia. CGM technology provides both patients and healthcare professionals with real-time data on glucose levels, making it a powerful tool in this balancing act.In this episode Dr Grace and Dr Polonsky share their insights from their research, highlighting significant reductions in A1C levels and improvements in patient outcomes with the use of CGM. They highlight the clinical benefits of CGM for managing glucose levels and making informed dietary and lifestyle choices. Additionally, they discuss the psychological effects of CGM including increased engagement, empowerment, and reduced anxiety. Dr Grace also introduces an exciting new product from Dexcom called Stelo, which will be an over the counter option for patients with type two diabetes (not on insulin), meaning that if your doctor is unwilling to write you a prescription for a Dexcom G7, you yourself can go to www.stelo.com and see if an over the counter product is appropriate for you.

Diabetes Core Update
Special Edition - Diabetes Core Update - CGM - January 2025

Diabetes Core Update

Play Episode Listen Later Jan 14, 2025 33:27


Welcome to this special edition of Diabetes Core Update, where host Dr. Neil Skolnik takes a deep dive into the transformative role of continuous glucose monitoring (CGM) in diabetes care. Through engaging conversations with two leading experts, Dr. Skolnik explores the latest advancements in CGM technology, its clinical benefits, and its growing accessibility. Packed with valuable insights, this episode is an essential listen for healthcare professionals navigating the evolving landscape of diabetes management. This episode is sponsored by Dexcom, the #1 HCP-recommended CGM brand* and creators of Dexcom G7. Presented by: Neil Skolnik, MD, Professor of Family and Community Medicine, Sidney Kimmel Medical College, Thomas Jefferson University; Associate Director, Family Medicine Residency Program, Abington Jefferson Health Eden Miller, DO, Founder of Diabetes Nation, a nonprofit organization, and CEO of Diabetes and Obesity Care, Bend, Oregon Eugene Wright, MD, Medical Director of Performance Improvement, Charlotte Area Health Education Center, Charlotte, North Carolina; Consulting Associate, Department of Medicine, Duke University Medical Center, Durham, North Carolina Select resources and studies mentioned in the podcast: https://pro.diabeteswise.org/en/resources https://www.aafp.org/pubs/fpm/issues/2024/0100/continuous-glucose-monitoring.pdf https://www.adces.org/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-insurance-coverage-look-up Miller E, Chuang JS, Roberts GJ, Nabutovsky Y, Virdi N, Wright Jr. EE: Association of changes in A1C following continuous glucose monitoring acquisition in people with sub‐optimally treated type 2 diabetes taking GLP‐1 RA therapy. Diabetes Therapy 2024;15:2027-2038 https://doi.org/10.1007/s13300-024-01619-1 This special episode of Diabetes Core Update is sponsored by Dexcom, the #1 HCP-recommended CGM brand* and creators of Dexcom G7 (1). Dexcom G7 is a continuous glucose monitoring system, designed for patients with all types of diabetes (2). The American Diabetes Association recommends the use of CGM in people with diabetes, as CGM is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range (3). Getting started with Dexcom G7 is easy, with only one prescription needed. Visit https://Dexcom.com/ADA for prescribing information and to sample Dexcom G7 for free. *Based on a comparison in NPS scores across major CGM brands. References 1. Seagrove Partners, LLC. Seagrove Partners HCP Perspectives. 2022 2. Dexcom. Dexcom G7 User Guide. 2023 3. American Diabetes Association Professional Practice Committee. Standards of Care in Diabetes—2025. Diabetes Care 2025;48(Suppl. 1):S1–S352

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jan 10, 2025 6:15


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more.  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:     Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success. This is very early and hasn't yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin. Sana's CEO says  “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.”   I've reached out to Sana to get more on this.. love to talk to them soon.   https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html XX FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).  Studies showed a meaningful reduction in A1C but a meaningful increase in DKA. The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD. Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors.  According to Lexicon, Inpefa will continue to be manufactured and made available to patients. https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/ XX Two companies we've been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They've announced a new partnership agreement. From the release: Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor." Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed.   https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg XX Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device.   https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/     XX Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems.   There's a long history here – UVA is where the Control IQ algorithm was developed.  This agreement seems to keep the team together for another decade. https://www.businesswire.com/news/home/20250107162995/en/Tandem-Diabetes-Care-Enters-Multi-Year-Research-Collaboration-with-UVA-Center-for-Diabetes-Technology-for-Development-of-Advanced-Insulin-Delivery-Systems XX New study says insulin is still the best treatment for gestational diabetes, compared to oral glucose-lowering medications. Metformin and gluburide are being closely looked at since they're easier to administer, less costly, and have better acceptance among patients. But this study says insulin was a bit better – slight more babies were born larger for the metformin group, and more moms had hypoglycemia. https://www.medpagetoday.com/obgyn/pregnancy/113651 XX In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza. Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding. https://www.biospace.com/fda/novo-launches-citizen-petition-to-block-compounded-victoza XX Bit of an update on compounded terzepatide and semaglutide. The FDA is allowing a grace period of 60 days before starting to enforce the end of allowing compounds of Mounjaro. Meanwhile, semaglutide remains on the FDA's shortage list for several dose strengths, though all doses have been reported as “available” since late October 2024. Compounding pharmacies, especially larger 503B “outsourcing facilities,” maintain they provide an essential public service by offering lower-cost versions of medications that can cost over $1,000 per month. Many insurers still refuse to cover brand-name GLP-1 products for weight loss. Yet  the FDA has reported hundreds of adverse event reports allegedly linked to compounded versions of these drugs, which do not undergo the same rigorous manufacturing inspections and clinical testing as approved brands.   https://www.drugdiscoverytrends.com/compounders-and-drugmakers-clash-over-compounded-weight-loss-drugs-with-fda-in-the-middle/ XX Interesting story here.. this study says a fecal transplant can help people with type 1 and severe gastroenteropathy. The researchers say diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited. Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention. After four weeks, Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome. https://www.medscape.com/viewarticle/fmt-shows-early-success-type-1-diabetes-bowel-issues-2025a10000bg XX A couple of weeks ago, listeners told me that the Dexcom geofencing issue we reported on seems to be resolved. Dexcom is now confirming this. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. As of last month, the geofencing issue has now been resolved with the latest Dexcom G7 2.6 app update. Can I travel with my Dexcom G7? | Dexcom XX Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead the U.S. market for CGMs, agreed on Dec. 20 to resolve all outstanding patent disputes and not sue each other over patents for 10 years.   Dexcom and Abbott previously reached a settlement in 2014 related to their diabetes devices, which included a cross-licensing deal and an agreement not to sue each other until 2021. After that agreement expired, the companies filed a volley of patent lawsuits. https://www.medtechdive.com/news/abbott-dexcom-settle-cgm-patent-lawsuits/736300/  

Diabetech - Diabetes Tech, News, and Management
Switching from Tandem t:slim X2 to Medtronic 780g - The Pros & Cons

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Jan 6, 2025 43:16


Today we dive into a head-to-head comparison of two leading automated insulin delivery (AID) systems, viewed through the lens of someone who has lived with diabetes since the 1950s. Our guest, Michael Dardenelle, shares his firsthand experience transitioning from the Tandem t:slim X2 and Dexcom G7 to the Medtronic 780g and Guardian 4 CGM, offering insights into how the Medtronic system has performed, his results with the new algorithm, and the features he misses from the Tandem system. Last week, we aired one of my favorite episodes featuring Michael's incredible journey. At 78 years old, he has faced numerous health challenges since his adolescence with type 1 diabetes but has remained a source of strength and inspiration for the diabetes community. If you haven't heard his story yet, I highly encourage you to check it out next—it's a moving and unforgettable interview. You can listen to that episode here.   Please fill out our 2024 Diabetech Podcast Survey   Learn about Omnipod 5 (today's sponsor)*   T1D Exchange Registry Sign up  (US only)   Read our Blog + Join the Newsletter    Support Diabetech on Patreon  | Diabetech Community Discord   Follow me here: Instagram | Tik Tok | YouTube | Facebook   Watch the Podcast on Youtube   DISCLAIMERS: This podcast is not medical advice and is for educational purposes only. Always consult with your doctor before making changes to your health care.   *10-day trial eligibility may vary. Full terms and conditions apply. Visit omnipod.com/diabetech for clinical disclaimers, terms and important safety information. The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Inhaled Insulin Studied for Kids, Dexcom Launches AI, App for Driving & T1D, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Dec 20, 2024 6:25


It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin. A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing. HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, There were no differences between groups or concerns in other safety measures, including hypoglycemia. https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex   XX Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health. Stelo users will start seeing the features this week. The AI is modeled after Google Cloud's Vertex AI and Gemini models. We'll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare. BTW this press release is the first time I've seen what seems to be a new slogan for Dexcom – Discover What You're Made Of. https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing XX Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention.   XX Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company. The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.   Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges. This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030. https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html     XX Can we add treating sleep apnea to the list of applications for terzepatide? That's the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea. Eli Lilly said there was nearly a 20% reduction in weight among those in the trials. The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year. https://www.aol.com/popular-weight-loss-drug-could-131507702.html   XX Health Canada okays Tandem's tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors. Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7's 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4. Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025.   To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca. https://www.businesswire.com/news/home/20241210731189/en/Tandem-tslim-X2-Insulin-Pump-Now-Compatible-with-Dexcom-G7-CGM-in-Canada XX A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps. The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision. Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps. In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million.   A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe's Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea.   The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet's trade secrets.   Insulet CEO Jim Hollingshead said the company is “extremely pleased with the jury's verdict.” EOFlow did not immediately respond to a request for comment. https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/ XX A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds. Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions. Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care. https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes XX New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable. In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them. We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support. For more information, please visit: https://lnkd.in/gTDhnDc4 XX I'm also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2. https://www.medscape.com/viewarticle/icymi-top-10-diabetes-endocrinology-stories-2024-2024a1000n6u?&icd=login_success_email_match_fpf XX That's it for the last In the News of 2024! Don't miss out episode next week with a look ahead to what we're watching in 2025. I'm SS I'll see you back here soon…

Diabetes Connections with Stacey Simms Type 1 Diabetes
Travel Alert: What You Need to Know About Geofencing and Dexcom G7

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Sep 3, 2024 31:53


Traveling with diabetes gives you enough to think about – especially traveling internationally: preparing, packing, going through airport security. But if you travel out of your country – not just the US – with your Dexcom G7, you also have to be aware of something called geofencing. If something goes wrong with your phone or your app.. getting it back is going to be an issue. We'll talk about how this works, why it's in place, and what you can do about it. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Find out more about Moms' Night Out - registration is open for Denver and Philadelphia! More from Dexcom More from Loop & Learn: https://www.loopnlearn.org/g7-geofence/ Stacey's free travel guide and packing list: https://bit.ly/DiabetesCxnsTravel Previous episode with Dexcom's Jake Leach Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

Beyond the Bolus
Omnipod 5 with Dexcom G7 Integration is Here!

Beyond the Bolus

Play Episode Listen Later Aug 19, 2024


Recorded live at the ADA Conference in Orlando, Florida. Nancy Hanna is joined by Dr. Pablo Mora who is an Endocrinologist at the North Texas Diabetes & Endocrinology Medical Center in Plano, Texas. During this episode, Nancy and Dr. Mora discuss the integration between the Omnipod 5 Automated Insulin Delivery System and the Dexcom G7 CGM. Dr. Mora discusses his experience as part of the Limited Market Release for Omnipod 5 with Dexcom G7 and provides insights into the benefit of this integration for his patients with type 1 diabetes. Listen to learn how Dr. Mora has leveraged this technology to simplify diabetes management with his patients! ------------Dr. Pablo Mora is an endocrinologist. Dr. Mora has an ongoing commercial relationship with Insulet and Insulet has paid him a fee to participate in this podcast. The opinions and views expressed in this podcast are his own.

Raising Rare
Find Your Real Friends in Your Rare Disease Community

Raising Rare

Play Episode Listen Later Aug 7, 2024 44:30


Type 1 Diabetes (T1D) is not considered a rare disease according to the numbers. The T1D community is quite large and includes people of all ages, races, geography, and conditions. However, many of our guests use the technology developed for T1D patients. In fact, Brittany's daughter Everleigh relies on the Dexcom G7 to manage her glucose levels. In this episode we speak with Suzanne Hansen, a mother of twins, one of whom was diagnosed with T1D just a few weeks after her second birthday. Suzanne has become part of Brittany's inner circle of T1D experts. We talk a lot about the tech, but the real story is the power of connecting with others who get what you are going through.Suzanne is active in her local T1D Facebook group and shares her story regularly on Instagram to help others who are trying to manage their kiddos glucose levels. Mentioned in this episode:Invitation to Check Out The AtlasThe Atlas

Diabetech - Diabetes Tech, News, and Management
Dexcom G7 Geofencing: What Travelers Need to Know

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Jul 29, 2024 28:27


Users are reporting they are unable to re-download the Dexcom G7 app outside their country. This is due to geofencing built into the smartphone app blocking users from downloading their home-country G7 app while abroad. If you plan to travel outside your country, here's what you should know and how to prepare if you use Dexcom G7.   Fill out T1D Exchange Registry  (US residents only)   Join Patreon for Exclusive Content | Join Diabetech Community Discord   Follow my other pages: Instagram | Tik Tok | YouTube | Facebook   Has this happened to you? Send us Feedback & Join the Newsletter   DISCLAIMER: This podcast is not medical advice. Always consult with your doctor before making changes to your health care. 

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News...Does insulin use differ by gender? T1D & Covid update, fully implantable CGM studied, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jul 19, 2024 9:21


It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A new study looks at insulin needs in men vs women, updates on stem cell transplants and a new look at COVID 19 and T1D plus a fully implantable CGM is announced. We'll also tell you about a T1D athlete drafted to the MLB. Lots more in this week's episode, full transcipt below.  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX Do men and women have different insulin requirements? A new study conducted across Europe says yes – women overall need less. Published in the Journal of Diabetes Science and Technology this looked at over 9,000 adults with type 1 diabetes using data from patients using the Diabeloop Generation 1 (DBLG1) hybrid closed-loop pump system. In this study, women needed 14-percent less insulin overall than men. These researchers say these findings have important implications for the practical management of insulin therapy and highlight the necessity of considering gender as a crucial factor in diabetes treatment. The treatment guidelines provided by American and European Diabetes Societies do not currently have gender-specific recommendations for insulin-weight ratios. The co-founder and Chief Scientific and Technical Officer for Diabeloop. “This study also highlights the capacity to discover new insights from big-data analysis of real-world data.” *Insulin Requirements According to Gender and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery, https://doi.org/10.1177/19322968241252366). https://www.theglobeandmail.com/investing/markets/markets-news/GetNews/27419187/diabeloop-study-reveals-significative-gender-differences-in-insulin-requirements-for-type-1-diabetes-patients/   XX New drug therapy in those lucky diabetic mice boosted insulin-producing cells by 700% over three months, effectively reversing the disease. Scientists at Mount Sinai and City of Hope have been able to grow new beta cells in the body, in a matter of months. The therapy involved a combination of two drugs: one is harmine, a natural molecule found in certain plants, which works to inhibit an enzyme called DYRK1A found in beta cells. The second is a GLP1 receptor agonist. The latter is a class of diabetes drug that includes Ozempic, The researchers tested the therapy in mouse models of type 1 and 2 diabetes.. The signs of the disease quickly reversed, and stayed that way even a month after stopping the treatment.   The results are intriguing, but of course being an animal study means there's still much more work to be done before it could find clinical use. So far, harmine alone has recently undergone a phase 1 clinical trial in humans to test its safety and tolerability, while other DYRK1A inhibitors are planned for trials in humans next year. https://newatlas.com/medical/diabetes-reversing-drug-boosts-insulin-producing-cells/ XX Stem cell–derived beta-cell replacement therapy continues to show benefit in people with type 1 diabetes at a high risk for severe hypoglycemia. New info from Vertex shows that of a total 17 patients who received a full dose of their  investigational allogeneic stem cell–derived, fully differentiated pancreatic islet cell replacement therapy (VX-880), three, thus far, have achieved the primary study efficacy endpoint of elimination of severe hypoglycemic episodes with A1c < 7% at 1 year and the secondary endpoint of insulin independence. Others are on the same trajectory, Piotr Witkowski, MD, PhD, professor of surgery at The University of Chicago, Chicago, said at the recent American Diabetes Association (ADA) 84th Scientific Sessions. In his presentation, Witkowski also provided details about the deaths of two study participants that the company had announced in January 2024, neither of which were related to the VX-880 product. In fact, there have been no severe adverse events related to the product itself, with most due to either the infusion procedure or the immunosuppression. "These data highlight the curative potential of VX-880 in people living with type 1 diabetes and support further evaluation of VX-880 toward pivotal development," Witkowski said. For now, patients selected for the study are those who experience frequent severe hypoglycemia deemed to be a greater risk to the patient than that of immunosuppression. However, Ahn pointed out, "With VX-880, the obvious fly in the ointment is the need for immunosuppression which carries significant risk…There are multiple solutions being proposed, but we are still waiting for data as promising as the initial Vertex data is on that front." https://www.medscape.com/viewarticle/stem-cell-derived-islets-continue-show-benefit-t1d-2024a1000cx1 XX Still lots of COVID studies coming in about type 1. A German study suggests COVID 19 may speed up progression of existing but presymptomatic T1D in kids. These researchers had been screening and following children in an early presymptomatic stage of type 1 diabetes for several years. They noticed an increase in the numbers of Incidence of clinical type 1 diabetes nearly doubled after the pandemic started. "We know that the virus can infect the pancreatic islets so it could be causing damage or change in the beta cells that make insulin," said Ziegler when discussing possible mechanisms behind this association. "Second, there is generalized inflammation during the infection and there may be a stimulation of the immune response. Third, there could be metabolic stress from the infection that affects the beta cells that make insulin. To dive into this topic, youth were identified in the German Fr1da-screening program from 2015 to 2023. All patients had presymptomatic diabetes defined as persistent, confirmed positive results for two or more islet autoantibodies. Their progression was monitored at 3- to 6-month intervals. Clinical type 1 diabetes was defined according to American Diabetes Association   COVID infection was either self-reported via the family or identified with SARS-CoV-2 antibodies were confirmed in blood samples collected at study visits.   Vaccination against COVID-19 may be one way to protect presymptomatic type 1 diabetes youth from progression, Ziegler added. She said her group is currently testing whether COVID-19 vaccination can reduce new-onset, presymptomatic type 1 diabetes in a clinical trial  of children with genetic risk factors for the condition. https://www.medpagetoday.com/endocrinology/type1diabetes/111084 XX The FDA says no – for now - to Novo Nordisk's weekly insulin.  This has been approved in Canada and should be available there shortly. But the FDA says it wants more information related to the manufacturing process and the type 1 diabetes indication to complete the review. Novo said it does not expect to be able to fulfil the requests this year, and that it will work closely with the FDA regarding the next steps. The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1 diabetes due to risks of low blood sugar. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-novo-nordisks-weekly-insulin-2024-07-10/ XX A couple of weeks ago we spoke to the attorneys taking on CGM monitronig in schools. They've helped a family in Connecticut and set a precdent.  A child with autism and diabetes was not getting reasonable accommodations under the federal Americans with Disabilities Act in a public preschool program. I'll link up the press release from the DOJ but this family wasn't getting any support and it just wasn't safe. The lawyers here tell me the ruling and settlement is just going to help them going forward as they try to make schools complient with CGM as a reasonable  accomodatin. https://www.justice.gov/usao-ct/pr/aba-therapy-provider-make-changes-comply-americans-disabilities-act   XX Ozempic could lower the risk of dementia and a range of other mental problems compared with other existing treatments for patients with diabetes. What's more, researchers found that Ozempic cut nicotine dependence in those patients.   This study relied on medical records from more than 100,000 U.S. diabetes patients, including more than 20,000 who were prescribed semaglutide between December 2017 and May 2021. After a year, patients who took Ozempic had a 48% lower risk of developing dementia than those on Januvia. The risk in Ozempic patients was also 37% lower than those who took Glucotrol and 9% lower than those on Jardiance. Notably, previous research has determined that diabetes patients are at a greater risk of developing dementia. But the authors emphasized that the analysis is observational. The results need to be replicated in a controlled trial that assigns patients to randomly take Ozempic and the other drugs, according to Dr. Max Taquet, another Oxford clinical lecturer and senior study author. https://www.cnbc.com/2024/07/16/healthy-returns-ozempic-may-lower-dementia-risk-nicotine-use.html XX   Edgepark Commercial XX The Omnipod 5 with Dexcom G7 integration is now available through select pharmacies with full availability expected in the fall.   The System uses new Pods that are compatible with both Dexcom G6 and G7, but the prescription code will stay the same as the current Omnipod 5 Pods. This means the community will have similar insurance coverage and access to what they have with Omnipod 5 today.   If you're looking to start on Omnipod 5 and you're currently using Dexcom G7, your doctor will need to send a prescription for both the Omnipod 5 Intro Kit and Omnipod 5 Pods, compatible with Dexcom G6-G7, to ASPN Pharmacies.   You can learn more at https://www.omnipod.com/innovation/dexcom-g7.   If you are already using Omnipod 5, you will get the new Pods compatible with Dexcom G6 and G7 through your Pod refills. You do not need a new prescription. The week of July 29th, you will receive a free software update for the Omnipod 5 App to your Controller or compatible Android smartphone which is needed to use the System with Dexcom G7. Accept the update. We recommend you continue to use your current Omnipod 5 Pods and Dexcom G6 supplies until the new Pods compatible with Omnipod 5 with Dexcom G6-G7 are available at your preferred pharmacy.   We'll email our users when the new Pods are available in most pharmacies.   You can learn more at https://www.omnipod.com/innovation/new-compatible-devices   XX Big promises about long-term implantable blood glucose monitor from a company called Focus. They say they're partnering with Glucotrack to quote - transform how people with diabetes interact with their condition. They're not calling this a CGM – rather it's a CBGM, continuous blood glucose monitor because it will measure glucose levels in blood, not in interstital fluid like CGMs do. They company says this is a fully subdermal location, with no external wearable. In preclinical studies, the CBGM has a MARD of 4.7% at day 90. That is MUCH lower than CGMs on the market – Dexcom and Libre are in the low 8s right now. BUT.. it hasn't been fully tested in people yet. Human clinical trials are set to start later this year. https://www.drugdeliverybusiness.com/focus-collaborates-glucotrack-implantable-cbgm/ XX Big congrats to Jamie Ferrer (Chy-may Fer-rare) On Monday, Ferrer's dream was realized when the Twins selected the Florida State outfielder in the fourth round (No. 126 overall) during Day 2 of the MLB Draft. Minnesota vice president of amateur scouting Sean Johnson said the club had its eyes on Ferrer since high school. “Recently, I was in Orlando at a conference called, “Friends for Life with CWD [Children with Diabetes],” and we had an event that was a sports day. … Kids would come up to me and either them or their families would ask me how I dealt with this [or that],” Ferrer said. “And seeing their faces light up whenever I said I was diagnosed at three and I played college baseball. … You hear people tell you no and that you can't do this because you have Type 1 diabetes … So why not inspire as many people as I can?”   “I'm super proud of being a Type 1 athlete, and it's something that I'll never shy away from talking about or showing off my insulin pump because it's who I am and it's something that I've had to deal with my entire life.” https://www.mlb.com/news/jaime-ferrer-selected-no-126-overall-by-twins-in-2024-mlb-draft XX Join us again soon!

Diabetech - Diabetes Tech, News, and Management
What's Next in Diabetes Tech? Highlights from ADA 2024

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Jul 15, 2024 31:02


I list off the tech I'm most excited about from the ADA's Scientific Sessions. I cover cgms like the Libre 3 Plus that now works with pumps and the latest Dexcom G7 upgrades. I get into pumps from the Omnipod iPhone app, the CeQur insulin patch, and the Luna overnight AID insulin pump. And I get into updates from the Vertex stem cell therapy findings that could lead to a cure for type 1 diabetes.    Find a Doctor on ZocDoc (today's sponsor)   Fill out T1D Exchange Registry  (US residents only)   Join Patreon for Exclusive Content | Join Diabetech Community Discord   Follow my other pages: Instagram | Tik Tok | YouTube | Facebook   More Videos from ADA: Interview with Dexcom: https://youtu.be/FTjeMorMY30 Twiist Demo: https://youtu.be/FXaK77aFcV8   Send us Feedback & Join the Newsletter   DISCLAIMER: This podcast is not medical advice. Always consult with your doctor before making changes to your health care. 

Diabetech - Diabetes Tech, News, and Management
Dexcom's New Sensor Replacement Policy & G7 Upgrades

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Jun 24, 2024 22:12


CEO Kevin Sayer explains Dexcom's has a new sensor policy, connection upgrades coming to Dexcom G7 - longer range and "Rapid Reconnect," and more. Follow our Youtube and social pages for more coverage of ADA 2024!   Fill out T1D Exchange Registry  (US residents only)   Join Patreon for Exclusive Content | Join Diabetech Community Discord   Follow my other pages: Instagram | Tik Tok | YouTube | Facebook   Send us Feedback & Join the Newsletter   DISCLAIMER: This podcast is not medical advice. Always consult with your doctor before making changes to your health care. 

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the news.. Insulin pen shortage, Omnipod 5 update, once-weekly insulin approved in Canada, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jun 21, 2024 7:59


It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: South Africa runs out of insulin pens - and why this could happen anywhere, once-weekly insulin is approved in Canada, update on Omnipod 5 with Dexcom G7 rollout, more older people are getting type 1 but more people are living longer with it, CGM at the Olympcs and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX Quick note – the American Diabetes Association Scientific Sessions is this weekend. That means new research studies will be released, technology announced, and likely lots of news will be made. I'm recording this before the conference starts – if there's enough going on we may have an additional In the News next week. XX Our top story right now… XX No more insulin pens for South Africa.. .as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs. Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen. Novo Nordisk's  drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A month's supply of Ozempic in the United States costs about $1,000, far more than insulin. Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound. Novo Nordisk is continuing to supply human insulin in vials to South Africa, where more than four million people live with diabetes, but pens are considered much easier to use and more precise. The vial system was phased out for most South Africans in 2014. But recently, South Africa's National Department of Health instructed clinicians that they should teach patients how to use vials and syringes of insulin instead of pens. I posted about this already and said this is a canary in the coal mine and everyone going to ADA should be asking Novo and Lilly about this. GLP medications are fantastic but insulin cannot be left behind. https://www.nytimes.com/2024/06/19/health/insulin-pens-south-africa-ozempic-wegovy.html XX Once a week basal insulin – for type 1 and type 2 – comes to Canada. Novo Nordisk announced that it's version of insulin icodec will be available starting June 30th. They are calling it.. Awiqli – I promise I didn't make that up.  Canada is the first country to get the product. Awiqli works as a time release of insulin over the course of a week. It is more expensive. And  Canada's Drug Agency, which assesses drugs and recommends whether they should qualify for reimbursement under public drug plans, is still doing the math here. No word on private insurers coverage yet. An FDA advisory board recently passed on approving weekly basal for people with type 1, saying the risk of low blood sugar was too great. But the full FDA hasn't yet weighed in.   https://www.ctvnews.ca/health/world-s-first-weekly-insulin-injection-coming-to-canada-in-2-weeks-manufacturer-says-1.6929321 XX The prevalence of people over 65 living with type 1 diabetes  went up 180% in the past 30 years, a new study finds. That's an increase of 1.3 million people over 65 in 1990 with the disease to 3.7 million in 2019, the authors noted in a study published on June 12 in The BMJ. Data included people from 204 countries and territories from 1990 to 2019. Dying from type 1 diabetes slipped by about 1% every year since 1990, the data also showed. The mortality for people 65 and up went down by 25% during the three decades covered in the study. The most rapid prevalence was in North Africa and the Middle East, and Western Europe, and the slowest increase in prevalence was in North America. All 21 regions around the world had an increased prevalence of type 1 diabetes in people over 65. The disease no longer contributes to a reduced life expectancy for many people due to medical care improvements, say these researchers. https://www.mcknights.com/news/report-type-1-diabetes-prevalence-in-older-adults-nearly-triples-since-1990s/ XX Hearing more about the limited rollout of Omnipod 5 with the Dexcom G7. This was announced in February but just seems to really be getting underway. A few people have received emails that people new to the system will be getting this first.. but that at the end of July current users will get a controller update so they can use G7 with the current pods. We'll have more on this soon – I don't have a link for you - but thanks to all of you who sent me those emails very much appreciate it. XX New life possible for Korean insulin pump EOPatch– this is a competitor to the Omnipod. A court has killed an injunction that meant the company, EOFlow, could not bring the patch pump to the US. Last year, the court initially granted that injunction and Medtronic backed out of an acquisition plan. No word yet from Medtronic if that deal is back on.. or if another company may work to bring EOFlow to the US. https://news.bloomberglaw.com/business-and-practice/ban-against-insulin-pump-patch-sales-reversed-by-federal-circuit XX The CeQur Simplicity patch is now FDA-cleared for up to 4 days of wear. This is a mechanical patch pump that replaces fast-acting injections. This is an extension from 3 days to four.. now each patch replaces up to 12 injections making it the longest wearable insulin delivery patch. The company says that can be 1000 fewer shots a year. Marketed mostly to people with type 2 diabetes who use insulin, the company says nearly 90% of patients using CeQur Simplicity reported following their insulin regimen better as compared to multiple daily injections.(4) The patch is clinically proven to improve glycemic control, with patients achieving significantly improved A1C and time-in-range (TIR) goals.(5,6) https://www.prweb.com/releases/cequr-simplicity-a-wearable-mealtime-insulin-delivery-device-obtains-fda-clearance-for-4-days-of-wear-to-further-simplify-diabetes-management-302173938.html XX A warning from Roche which says “dangerous counterfeits” of its diabetes medical devices ended up for sale on Amazon. Roche accused manufacturers and sellers based in India of selling counterfeit versions of test strips for its Accu-Chek glucometers.  This is part of a federal lawsuit. Roche said the counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's registered U.S. trademarks and fake expiration dates. After the suit was filed, a judge granted Roche's request for a temporary restraining order to stop the defendants from selling the counterfeit products. The Amazon stores that were offering the products for sale appear to have been taken down. Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme all of the counterfeit products sent to the U.S. were stored at Amazon warehouses across the country, including in Brooklyn. https://www.cnbc.com/2024/06/10/roche-counterfeit-diabetes-medical-devices.html XX Edgepark Commercial XX Summer Olympics this year may be a showcase for CGMs. Abbott is sponsoring a Dutch long distance running, he'll be wearing the Libre. Other athletes are using the CGMs in training and may wear as allowed in their sports. There isn't a lot of proof yet that these devices make a big difference for people without diabetes.. but high level athletes are looking for any edge possible. Expect to hear a lot more about this in the lead up to the Olympics July 26th. https://learningenglish.voanews.com/a/olympic-athletes-turn-to-diabetes-technology-in-medal-chase/7653234.html XX Join us again soon!

Rich On Tech
Google Pixel 8a Review & Unique Motion Sensor

Rich On Tech

Play Episode Listen Later Jun 9, 2024 107:47


Rich mentioned two helpful travel sites in his Newsletter: PointsYeah allows you to search across multiple points and rewards programs at once for flights and hotels, and Turbli allows you to check the turbulence forecast for your flight.Rich says the Nothing Ear buds are excellent.Rich talked about portable chargers for your smartphone. The more mAh, the more charges you'll get (10,000 is a good bet); look for USB-C charging in AND out for faster charging. Anker and Belkin are good bets.Keith in Andover, Kansas wants to know which AI to use. Rich likes ChatGPT for general, overall chatbot activities, Gemini for access to real-time information and the web, Claude for excellent language and summarization skills, CoPilot for creativity and Perplexity AI for “book reports” on a topic.Roxton in Ventura is having issues with his Moto 5G.Instagram is testing unskippable ads.Netflix is ending support for second and third-generation Apple TVs on July 31, 2024.Jay from Woodland Hills has a Samsung S10 and wants to put an AirTag equivalent in his car and wants to know which one. You want a tag that works on Android's Find My Device network. Rich says to look at Chipolo and Pebblebee but the shipping times are delayed.Sean in La Costa, CA wants to switch back to an Android after using an iPhone for a bit. Rich recommends iMazing, AltTunes and SMS Backup & Restore.Apple says it will support the iPhone 15 and later models for at least 5 years, but historically, they have done software updates for six years.Rich highly recommends the $500 Pixel 8a if you want a great smartphone with clean software and an excellent camera.Carol in Los Angeles is wondering how she should protect her credit and identity. Rich mentioned WalletHub and AnnualCreditReport.com and consider freezing credit reports. You can also request your Lexis Nexus profile.Drew Binsky, a travel YouTuber who has visited every country in the world, will discuss his new book called Just Go. He mentioned tech tools including Google Maps Offline Mode, Airalo for eSIMs, GetYourGuide and ToursByLocals.Mark in Winnekta is having issues with YouTube saying he's using an ad blocker.Microsoft is listening to consumers and changing the way its upcoming AI feature called Recall works. It will now be opt-in instead of turned on by default, and you have to use Windows Hello to access it.Rich mentioned reading a hard-cover book for the first time in a long time. It's Eruption by Michael Crichton and James Patterson.Adobe says it does not claim ownership over customer work, clarifying new terms of service that upset many users.Apple Watch now pairs directly with the Dexcom G7.Mahboud and Nicky Zabetian, creators of the Kini wireless motion sensor. Use code RADIO for a discount.Ebay will no longer accept American Express as of August 17, 2024.Max is raising prices, and Spotify is too.BBB warns that phishing scams are up and offers ways to spot them. Get full access to Rich on Tech at richontech.tv/subscribe

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Dexcom to Apple Watch, Metformin during pregnancy, Mounjaro shortage update... and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jun 7, 2024 10:31


It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: Dexcom goes Direct to Watch in the US, Abbott gets FDA okay for its OTC CGM, new study about metformin during pregnancy, an update on semaglutides, JDRF changes its name, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX Our top story this week – some CGM news… Dexcom announces Direct to Watch is here in the US. From the release: Using its own dedicated Bluetooth connection, Dexcom G7 sends glucose information and personalized alerts right to a user's Apple Watch. Dexcom G7 is the only CGM system that can display glucose on multiple devices simultaneously and independently, including on a smartphone, smart watch, receiver or connected automated insulin delivery system.‡ Apple products are built with strong privacy protections and users have control over their data in the Health app. (If you like to keep track of these things, we are just over 7 years since the official announcement this was going to happen) XX FDA approves Abbot's over-the-counter continuous glucose monitoring system. It's called Lingo and comes a couple of months after Dexcom won clearance for its Stelo over-the-counter CGM. Abbott has been selling Lingo in the UK as more of a lifestyle device – not aimed at people with diabetes. They call it a consumer biowearable designed to help people make decisions about their overall health and wellness; Lingo is not intended for use in diagnosis, treatment or management of a disease or medical condition. No word yet on exactly what kind of app they'll launch here in the US or if it will be marketed toward people with diabetes like the Libre currently is.. just as an OTC option. While it seems like the same hardware, the company has not confirmed that. https://www.drugdeliverybusiness.com/abbott-wins-fda-clearance-for-its-lingo-otc-glucose-monitor/ XX New study looking at the use of continuous glucose monitors (CGMs by rural children and adolescents living with type 1 diabetes. Previous studies examining the use of CGMs by children relied on prescription records to identify use of these devices, but just because someone is prescribed a CGM does not mean that they use one; barriers such as cost can stand in the way. this study instead identified use of these devices according to billing codes for the interpretation of CGM readings by the provider. The results unearthed a sizeable disparity. Those living in rural areas were significantly less likely to use a CGM than those in urban areas, even after adjusting for sex, race or ethnicity and insurance type. Specifically, compared with youth living in urban areas, the use of CGMs was 31% lower for children and adolescents living in small rural towns, and 49% lower for those living in isolated rural towns. The gap between rural and urban patients persisted across the four years of the study, even as the use of CGMs increased for all patient types during this time. These results are also relevant to people with type 2 diabetes who require insulin, Tilden said. The results also revealed that non-White patients, those who had public insurance and patients who lived in areas with a higher NPI all were less likely to use CGMs. More research is needed to explore the reasons for these disparities, but Tilden said they likely are a function of such issues as cost, reduced internet access, which CGMs require to relay their data, and distance from clinics and Medicaid-contracted pharmacies.   The next step is figuring out how to eliminate those disparities. These researchers are seeking funding to design an intervention that uses telemedicine and partners with a network of 35 clinics across Kansas to deliver specialty care to diabetes patients in rural areas.   https://www.kumc.edu/about/news/news-archive/diabetes-monitoring-disparities.html XX Metformin is just as safe to use during pregnancy to treat type 2 diabetes as insulin. The study, which hasn't been published yet in a peer-reviewed journal, tracked health data and potential long-term side effects of using metformin during pregnancy for up to 11 years postpartum. While today's popular GLP-1 medications, such as Ozempic, are not approved yet for use during pregnancy, metformin and insulin have been used during pregnancy for decades. https://www.medicalnewstoday.com/articles/metformin-may-be-as-safe-as-insulin-to-treat-diabetes-during-pregnancy XX Once weekly basal insulin is a no go from an FDA advisory panel. They found the potential benefits of the investigational once-weekly basal insulin analog icodec (Novo Nordisk) don't outweigh the increased risk for hypoglycemia in people with type 1 diabetes. We've been following this for a long time. Most of the trials here have been in people with type 2 – and the FDA hasn't publicly raised concerns about efficacy and safety seen in any of those trials. But the type 1 trial found a significant increase in serious or severe hypoglycemia with icodec compared with degludec (4.66 vs 1.0 events per 100 patient-years; 14 events in nine patients versus three in three patients), with the greatest incidence in the icodec group on days 2-4 after injection. None of the events resulted in treatment discontinuation or study withdrawal. This doesn't mean the FDA can't approve the drug – and the panel mentioned that they hope the FDA would work with Novo Nordisk to – quote - make sure that if this is approved there are as many guardrails as possible to make sure we don't harm people with type 1 diabetes." https://www.medscape.com/viewarticle/advisory-panel-votes-against-once-weekly-insulin-type-1-2024a10009we XX The shortage of Ozempic and Mounjaro continues… with some doctors offering advice of what to do if you can't fill your prescription. Health care company Ro recently launched a public crowd-sourced shortage tracker to help patients. The company says they also share the patient-reported shortages to the FDA. Chae says some patients could discuss with their doctor off-label use of other medications, like liraglutide injections (such as Trulicity, for example), depending on their preexisting conditions. Patients may also consider trying compounded semaglutide. Compounded drugs are made to order in local pharmacies, but Chae says be wary of them: Because of their bespoke nature, the drugs' safety isn't regulated by the FDA. “The state of Mississippi, North Carolina and West Virginia have banned these compounded drugs,” he said. https://www.scrippsnews.com/health/popular-diet-and-diabetes-drugs-in-short-supply-as-demand-surges XX Commercial XX Big news from JDRF – they've changed their name to "Breakthrough T1D." Here's the statement: "Breakthrough T1D was selected following a rigorous, data-informed process because it more accurately conveys the nonprofit's ability to connect with and work on behalf of the entire type 1 diabetes community," The median age for a person living with T1D worldwide is 37 years. Only about one in five are aged 20 years or younger, two thirds are aged 20-64 years, and another one in five are aged 65 years or older.   The organization was founded in 1970 by parents of children with T1D and was originally called the "Juvenile Diabetes Foundation." The "research" part was added in 2012 to reflect that aspect of its mission. We will have much more on this next week – Tuesday's episode is an interview with JDRF. Oops with Breakthrough T1D. https://www.medscape.com/viewarticle/type-1-diabetes-group-grows-jdrf-now-breakthrough-t1d-2024a1000afr XX Android users – heads up! The FDA has approved a hybrid, closed-loop, insulin-delivery Android app. In May, CamDiab, revealed that the CamAPS FX had received approval. CamAPS FX is approved for people with type 1 diabetes who are two years of age or older, including those who are pregnant.   CamAPS FX works in unison with the FreeStyle Libre 3 and the Dexcom G6 to produce a hybrid, closed-loop system that is compatible with the Ypsomed mylife YpsoPump. The app and those pumps are already approved in several other countries. You may recall that the YspoPump had a partnership with Lilly to bring that pump to the US – but that deal died in 2022. Yspomed is still moving forward to get FDA approval for their pump. https://beyondtype1.org/fda-approves-camaps-fx-hybrid-closed-loop-insulin-delivery-app/?fbclid=IwZXh0bgNhZW0CMTEAAR137RhLAt2GfIJ_BBYMrhU2R-maQ0EQmwOFhPfKN9iCnG2BKWY6dEB0sTk_aem_ATLPk1xWOnLNzPz7LvYINbTdCVMZk7pcRmma2pgG5MIo0OfinomTSgjsTsTpW_fE6GNVRnScZS6UGzaTvP1SewNW XX Driven by payments for diabetes treatments — especially insulin — prescription drugs for metabolic diseases now make up nearly one quarter of total national pharmaceutical spending, reported a study of spending trends by therapeutic class. The detailed examination of a decade's worth of US drug spending also found changes in who pays for the medicines, with an overall drop in out-of-pocket costs, except in the metabolic disease category. The findings add to concerns about the costs of US diabetes treatments. Annual US spending on diabetes medicines surged from $27.2 billion in 2011 to $89.2 billion in 2020,  according to this paper was published online in Research in Social and Administrative Pharmacy. In the same period, total annual pharmaceutical spending rose at a far slower rate. Yet much of the persistent gain in the cost of diabetes treatments in this same period was due to a decades-old drug, insulin, a cornerstone of diabetes care. https://www.medscape.com/viewarticle/study-raises-concerns-about-rising-cost-diabetes-meds-2024a1000a8e XX The number of people aged over 16 with insulin-dependent diabetes and eating disorder symptoms is as high as one in four, a study has revealed. Researchers from the University of Eastern Finland examined the findings from 45 past studies, looking at data from almost 11,600 people with insulin-dependent diabetes. They say that understanding the extent of the issue is the first step in developing treatment pathways, citing Finland as an example of a country which does not have care pathways for people with both diabetes and eating disorders. Of course, neither does the US. Typical eating disorder symptoms include restricting food intake and binge eating. Symptoms particular to insulin-dependent diabetes include insulin omission, which is when individuals restrict or skip insulin doses due to fears of putting on weight. The prevalence of eating disorder symptoms was higher in women than in men, a finding previously made in young people too. The age of an individual was not found to be a factor, with eating disorders occurring regardless of age group. https://www.diabetes.co.uk/news/2024/jun/1-in-4-people-with-insulin-dependent-diabetes-have-eating-disorder-symptoms-research-shows.html XX Congrats to Kate Farnsworth who recently won Diabetes Action Canada Catalyst for Change award. Many of you know Kate from the early DIY days.. Kate Farnsworth is the patient partner co-lead for the Innovations in Type-1 Diabetes Program. Kate has been heavily involved in the Do-It-Yourself #wearenotwaiting movement since her daughter Sydney was diagnosed with type 1 diabetes at the age of 8. With a background in information technology and graphic design, Kate has lent her skillset to developing diabetes watch faces for remote monitoring used by patients worldwide. Kate has created an online patient-driven support community for people who are exploring DIY closed-loop solutions and continues to advocate for all people with diabetes to have access to the best tools to manage their diabetes. Very nice to see this award go to someone very well deserved. XX Join us again soon!

Real-Time Real Talk by Dexcom
Clinical Accuracy in CGM and Why it Matters

Real-Time Real Talk by Dexcom

Play Episode Listen Later Jun 3, 2024 32:34


Welcome back to another episode of Real Time Real Talk where this week, host Cher Pastore is joined by Dr Jessica Castle and Dr Stayce Beck to discuss the meticulous process behind the formulation and execution of Continuous Glucose Monitoring (CGM) accuracy trials. The trio discuss the influence of rigorous trial design and transparency on the accuracy and reliability of CGM devices, particularly those developed by Dexcom. They highlight the importance of CGM research's credibility, strategies to minimize bias, and the essential role that regulatory bodies play in ensuring quality health research. The discussion also covers the dynamics of conflicts of interest, patient and healthcare provider education, and the significance of detailed metrics for evaluating CGM performance. Our expert panel also take us behind the scenes to reveal the meticulous work involved in creating and executing CGM studies that encompass different populations and conditions. You'll hear discussions around key performance metrics in a CGM accuracy study, understanding why blood glucose monitor and CGM readings might not match and the explanation of relative difference and CGM accuracy. The conversation highlights the comprehensive journey towards ensuring users can trust their CGM readings, right from day one to real-world applications. Finally, listen as they walk us through the process of bringing transparency to CGM data analysis, alongside discussing the potential challenges and future of CGM device application in pediatric hospital discharge programs, probing into the potential barriers and challenges faced by healthcare providers and patients. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Jessica R. Castle, MD and Stayce E. Beck, PhD, MPH, are employees of Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Castle JR, Beck SE. The Importance of Trial Design in Evaluating the Performance of Continuous Glucose Monitoring Systems: Details Matter. Journal of Diabetes Science and Technology. 2024 Feb 23 2. Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial Glucose Monitoring (CLSI Guideline POCT05). 2nd ed. Wayne, PA: CLSI; 2020. 3. Garg SK, Kipnes M, Castorino K, et al. Accuracy and safety of Dexcom G7 continuous glucose monitoring in adults with diabetes. Diabetes Technol Ther. 2022;24(6):373-380. 4. Laffel LM, Bailey TS, Christiansen MP, et al. Accuracy of a seventh-generation continuous glucose monitoring system in children and adolescents with type 1 diabetes. J Diabetes Sci Technol. 2023;17(4):962-967. 5. Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes technology & therapeutics. 2024 May 1;26(5):307-12. 6. Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical performance evaluation of continuous glucose monitoring systems: a scoping review and recommendations for reporting. J Diabetes Sci Technol. 2023:17(6):1506-1526.

Taking Control Of Your Diabetes - The Podcast!
Highlights from the Recent Diabetes Technology Meetings in Europe (ATTD 2024)

Taking Control Of Your Diabetes - The Podcast!

Play Episode Listen Later Apr 8, 2024 33:53


Join us as we talk about our experience at the 18th Annual Diabetes Technology Meeting in Europe (ATTD 2024). In this podcast, we'll be unpacking our favorite lectures from the event, which hold some very exciting data and insights. From cutting-edge advancements in diabetes technology to the latest developments in medications, we'll cover it all. Tune in as we explore the forefront of diabetes innovation and share our experiences from this meeting!In this episode, we will talk about:What updates are happening in diabetes technology? What are updates in diabetes medications? What is new with CGMs and Type 2 Diabetes? What is the silence all alert on your Dexcom G7? What is a continuous ketone meter and when is it coming? What is the most common cause of DKA in type 1's? What is time in tight range? What is Tzield (data information)? What is the new data on Afrezza? What is new information about SGLT2 inhibitors? What data information came out regarding Mounjaro? Show notes:Diabetes Technology Podcast - https://tcoydthepodcast.transistor.fm/47TCOYD Video Vault - https://tcoyd.org/tcoyd-video-vault/TCOYD Live PLUS Diabetes Technology https://tcoyd.org/live-feb-2024/?  ★ Support this podcast ★

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives
Dexcom Stelo and CGM Updates, with Jake Leach

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

Play Episode Listen Later Mar 22, 2024 28:26


Hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives recorded a special edition episode with Jake Leach, chief operating officer of Dexcom. The episode itself represents a follow-up to a conversation a year ago at International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2023, where Leach discussed the ongoing global rollout of the Dexcom G7 and how he expected expanded coverage of the device to open doors to greater personalization of care for people with diabetes. In the current episode, Leach and hosts touch upon the Stelo clearance, its accuracy relative to other CGM devices, plans for rollout and pricing, the importance of increased accessibility of CGM technology, and the push for greater accuracy in glucose monitoring devices. Video Version: https://www.hcplive.com/view/diabetes-dialogue-stelo-news-and-dexcom-cgm-updates-with-jake-leach Episode Highlights 00:30 - Jake Leach Introduction 01:20 - Dexcom Stelo Overview 06:25 - Differences vs G6 and G7  14:45 - Direct to Watch Technology 20:05 - Future of Dexcom Portfolio

Real-Time Real Talk by Dexcom
Navigating Pregnancy with Diabetes: CGM Strategies for Success

Real-Time Real Talk by Dexcom

Play Episode Listen Later Mar 20, 2024 27:41


Tune in to the latest episode of Real Time Real Talk with your host Cher Pastore, MS, RD, CDCES, BC-ADM. In this episode we take a deep and insightful look at the ever-evolving landscape of Continuous Glucose Monitoring (CGM) systems specifically within pregnancy with our guest, Dr Kristin Castorino. We explore in detail how this technology benefits pregnant patients with diabetes, focusing on the practicality of using devices like Dexcom G7 and how they aid both clinicians and patients in navigating this complex yet essential side of prenatal care. Get a first-hand perspective on the benefits, challenges and the road ahead in diabetes care as Cher and Kristin delve into how CGM systems make data interpretation easier. They also discuss the data abundance and the changes needed to mitigate the information overload it can often cause. Finally, Kristin discusses common misconceptions about CGM, the key role played by insurance coverage in the adoption of CGMs, and takes a look into the promising developments in the near future. From debunking myths and clarifying concerns about CGM to emphasizing how this technology feeds into a more integrated care environment, this is an episode you won't want to miss. Performance of the Dexcom G7 CGM System in Pregnant Women with Diabetes paper: https://pubmed.ncbi.nlm.nih.gov/38315503/ Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Kristin Castorino, MD is a paid spokesperson for Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom Clarity Clinic Login: https://clarity.dexcom.com/professional/ Dexcom Provider website: https://provider.dexcom.com Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Polsky S, Valent A, Isganaitis E, Castorino K, O'Malley G, Beck S, Gao P, Laffel LM, Brown FM, Levy C. Performance of the Dexcom G7 CGM System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 Feb 5. doi: 10.1089/dia.2023.0516. Epub ahead of print. PMID: 38315503. 2. ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 6. Glycemic Targets: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S97-S110. doi: 10.2337/dc23-S006. PMID: 36507646; PMCID: PMC9810469.

Taking Control Of Your Diabetes - The Podcast!
Evaluating Diabetes Technology: The Pros & Cons of Different Devices, with David Ahn, MD

Taking Control Of Your Diabetes - The Podcast!

Play Episode Listen Later Mar 13, 2024 36:07 Transcription Available


Evaluating Diabetes Technology: The Pros & Cons of Different Devices – Featuring David Ahn, MD Endocrinologist; Chief of Diabetes Services, HoagTAKING CONTROL OF YOUR DIABETES® - THE PODCAST! ...With Expert Endocrinologists Living with T1D, Drs. Steven V. Edelman & Jeremy PettusIn this episode, we talk about the most popular CGM and insulin delivery systems that have changed the diabetes world. Our special guest David Ahn, MD, Endocrinologist and chief of Diabetes Services, Hoag shares his insights on diabetes technology and it's future.In this episode, we will talk about:Who is David Ahn?The importance of CGM technology in the modern worldCGMs covered in this episode: Dexcom G7, Libre 2, Libre 2 PLUS and Libre 3, EversenseHybrid closed-loop systems overview & insulin delivery systems (AID): Tandem & Mobi from Control IQ, Omnipod 5, Medtronic 780G, iLet Bionic PancreasHow CGMs influence a basal insulin rateAn “algorithm” as a brain of CGMSteve's experience with Medtronic 780GFollow our guest David Ahn on Instagram: https://www.instagram.com/ahncall/Connect with Our Supporting Diabetes Companies:Dexcom: https://shorturl.at/wzARXMedtronic: https://shorturl.at/orwB8**Tune in for 2 new episodes each month! Like what you hear and want to help us grow? Please rate and review this podcast so we can reach more people living with diabetes!** ★ Support this podcast ★

Man in the Arena with Craig Spear
The Power of Glucose Data for Optimal Health

Man in the Arena with Craig Spear

Play Episode Listen Later Mar 2, 2024 22:02 Transcription Available


Strap on your seatbelts as we take on a journey through the bloodstream with the wonders of Continuous Glucose Monitors (CGMs)— a revelation in health tech that's ignited my curiosity and may just spark yours too. Imagine having a window into the ebb and flow of your blood sugar levels, right at your fingertips, in real time. That's the daily reality I've embraced with my CGM, a device that's not just for diabetics but anyone curious about the body's response to food and lifestyle choices.The landscape of glucose monitoring is vast and intricate, but I've navigated the terrain to bring you the lowdown on some heavy hitters like the Freestyle Libre II and the Dexcom G7. Whether you're tuning in from Canada or the U.S., you'll gather the info on everything from costs to prescription quirks. But there's more to this tech than meets the eye—beyond the numbers and graphs lies the ability to decode your body's cryptic messages on how it handles that slice of pizza versus a kale salad. It's these nuances that have transformed not just my relationship with food, but also how I sculpt my body and energy levels.Now, before you race to get your hands on a CGM, let's pump the brakes and consider a few road signs. These tools are potent, but they're not one-size-fits-all, and jumping in unprepared can leave you lost in a sea of data. I'll share my roadmap for when and how to integrate a CGM into your health regimen, ensuring you're well-equipped to make the most of this technology. Enjoy!Did you find this episode helpful insightful or motivating? If so, let's connect! You can find me on....InstagramLinked InThe Spear Method Website

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives
Understanding MARD, Comparing Popular CGM Sensors

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

Play Episode Listen Later Feb 29, 2024 21:43


In this episode, the hosts breakdown a pair of recent publications related to better understanding the strengths and limitations of MARD as well as a study comparing the Dexcom G7 and FreeStyle Libre 3 sensors. Video version: https://www.hcplive.com/view/diabetes-dialogue-understanding-mard-comparing-popular-cgm-sensors Key Highlights: 00:35 - The Myth of MARD 04:10 - Considerations When Interpreting MARD 10:15 - FreeStyle Libre 3 vs. Dexcom G7

Real-Time Real Talk by Dexcom
Exercise, Type 1 Diabetes and CGM: Cutting-Edge Insights from Recent Studies

Real-Time Real Talk by Dexcom

Play Episode Listen Later Feb 14, 2024 40:09


In another episode of Real Time Real Talk, host Cher Pastore invites Dr Dessi P. Zaharieva, PhD, CEP, CDCES to discuss all things diabetes. Dessi completed her PhD in Kinesiology & Health Science at York University under the supervision of leading diabetes researcher, Dr. Michael Riddell. She is currently working with Dr. David Maahs and the University of Stanford team to improve clinical outcomes in youth with type 1 diabetes. Her research focuses on effective strategies to reduce blood sugar fluctuations (i.e. hypoglycemia) during exercise and in recovery in individuals with type 1 diabetes. Dessi has been living with type 1 diabetes for over 25 years and is also an award-winning high-level athlete within Brazilian Ju-Jitsu. She understands the challenges associated with exercise and blood glucose control and is very passionate about diabetes research, specifically the body's response to different types of physical activity. During the episode, Dessi runs through some clinical studies and interprets insights from them to provide practical and valuable advice on various types of exercise, insulin doses, and current glucose trends. The speakers also explore the importance of continuous glucose monitoring in managing diabetes and the role played by patient-centred care. Finally, Dessi explores how technology advancements in health care have led to the development of tools that simplify guideline applications in practical real-time scenarios. Learn how professional health care specialists like Dessi harness the knowledge gained over decades of research to ensure that it translates into ready-to-use strategies for those with diabetes. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dessi Zaharieva is a paid spokesperson for Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. Dexcom Provider website Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. "It changed everything we do": A mixed methods study of youth and parent experiences with a pilot exercise education intervention following new diagnosis of type 1 diabetes. Tanenbaum ML, Addala A, Hanes S, Ritter V, Bishop FK, Cortes AL, Pang E, Hood KK, Maahs DM, Zaharieva DP; 4T Study Group. J Diabetes Complications. 2024 Jan;38(1):108651. doi: 10.1016/j.jdiacomp.2023.108651. Epub 2023 Nov 24.PMID: 38043358 2. Diabetic ketoacidosis (DKA) at diagnosis in youth with type 1 diabetes (T1D) is associated with a higher hemoglobin A1c even with intensive insulin management. Zaharieva DP, Ding V, Addala A, Prahalad P, Bishop F, Hood K, Desai M, Wilson DM, Buckingham BA, Maahs DM. Diabetes Technol Ther. 2023 Nov 13. doi: 10.1089/dia.2023.0405. Online ahead of print.PMID: 37955644 3. Practical Aspects and Exercise Safety Benefits of Automated Insulin Delivery Systems in Type 1 Diabetes. Zaharieva DP, Morrison D, Paldus B, Lal RA, Buckingham BA, O'Neal DN.Diabetes Spectr. 2023 May;36(2):127-136. doi: 10.2337/dsi22-0018. Epub 2023 May 15.PMID: 37193203 4. Hermanns N, Heinemann L, Freckmann G, Waldenmaier D, Ehrmann D. Impact of CGM on the Management of Hypoglycemia Problems: Overview and Secondary Analysis of the HypoDE Study. J Diabetes Sci Technol. 2019 Jul;13(4):636-644. doi: 10.1177/1932296819831695. 5. Urakami T. The Advanced Diabetes Technologies for Reduction of the Frequency of Hypoglycemia and Minimizing the Occurrence of Severe Hypoglycemia in Children and Adolescents with Type 1 Diabetes. J Clin Med. 2023 Jan 18;12(3):781. doi: 10.3390/jcm12030781

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Spray insulin tested, Dexcom T2D sensor submitted, A1C period pads... and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jan 19, 2024 7:34


It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Vertex pauses their stem cell transplantation trials after a patient death, spray insulin is tested, learning more about Dexcom's sensor for type 2, measuring A1C through menstrual blood and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcript: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX Our top story this week… XX Vertex Pharmaceuticals, Inc. has paused a study of stem cell–derived, fully pancreatic islet cell replacement therapy (VX-880) following two patient deaths. Neither death is related to the therapy itself - called VX-880 – according to the company. Vertex says they plan to share full data soon. In the study that was paused, 14 patients with type 1 received infusions of VX-880 and standard immunosuppression. After 90 days, 13 of the patients have an A1C under 7 without using exogenous insulin. This was the study that made a big splash in the New York Times in late 2021 with the headline “A Cure for Type 1 Diabetes?” and featuring Brian Shelton among others. Shelton is one of the two patients who have died.   https://www.medscape.com/viewarticle/vertex-pauses-islet-cell-study-after-patient-deaths-2024a10000oe XX Early days but researchers in Norway are testing an insulin body spray. Patients squirt the insulin directly on to their inner forearm, where skin tends to be thinner, allowing easier absorption. Within minutes, it gets absorbed into the bloodstream. This joins other research on skin patches packed with micro-needles that punch tiny and reportedly painless holes in the skin to let insulin seep through. The spray contains insulin and propylene carbonate, a chemical often used in cosmetic skin creams to help them penetrate the outer layers of the skin. In this case, it's hoped the chemical — attached to insulin in the spray droplets — will help the hormone seep as far as the tiny blood vessels that lie beneath the surface of the skin, where the hormone will then get absorbed into the bloodstream.   InsuLife, the Norwegian company developing the body spray, is setting up a trial involving 12 patients with type 1 diabetes to see how different doses of the spray compare with injected insulin in controlling blood-sugar levels. It is used just before a meal, like injected insulin.   The clinical trial was set up after a study involving five people found the spray reduced blood sugar levels by about 20 per cent after a meal. https://www.dailymail.co.uk/health/article-12965203/insulin-spray-arm-diabetes-jab-Hope-sight-millions.html XX The FDA clears the Qvin's Q-Pad™ A1c Test System which uses menstrual blood to get an A1C result. The kit is intended for the collection of menstrual blood samples by individuals 18 years of age and older using the Q-Pad, a pad with an embedded blood collection strip (Q-Strip). Each kit includes 2 Q-Pads, a return sample container, and a stamped mailing pouch. The FDA clearance was based on data from a clinical validation study that included 198 participants. Samples were collected using the Q-Pad Kit and were returned to the laboratory by mail. To provide the reference sample, a venous blood draw was performed on participants by a phlebotomist. An analysis of both samples demonstrated that the clinical performance of the Q-Pad test system in measuring HBA1c was equivalent to the traditional method of blood testing. https://www.empr.com/home/news/fda-approved-q-pad-test-system-uses-menstrual-blood-to-measure-hba1c/ XX Learning more about Dexcom's upcoming CGM designed for people with type 2 who don't use insulin. It's to be called Stelo and they've submitted to the FDA with an eye on a late summer launch. I was at the announced last June – this is a system that will have very few alerts and alarms.. Stelo looks a lot like the G7 but will have different software and will last for about 15 days per sensor. https://www.theverge.com/2024/1/11/24034098/dexcom-stelo-cgm-diabetes-health-tech-ces-2024 XX Tandem Diabetes Care's t:slim X2 Insulin Pump Automated Insulin Delivery System is now the first to incorporate the Abbott FreeStyle Libre 2 Plus Sensor for users in the United States. The FreeStyle Libre 2 Plus sensor is a modified version of the FreeStyle Libre 2 sensor cleared in 2023 by the US Food & Drug Administration for use with automated insulin delivery (AID) systems. The move follows Tandem's December announcement of integration with the recently available 10-day Dexcom G7 sensor. https://www.medscape.com/viewarticle/tandem-insulin-pump-system-integrates-libre-sensor-2024a10000iq?form=fpf XX If you use Omnipod 5 with an Android, there's a software update you need to do. The FDA has issued a Class one correction recall. due to a software error that occurs when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point. This recall is not a product removal and users should have already received an alert that won't let them use the app until they do the software update. https://www.fda.gov/medical-devices/medical-device-recalls/insulet-corporation-recalls-omnipod-5-android-app-due-software-error#:~:text=Reason%20for%20Recall,zero%20before%20the%20decimal%20point. XX   Embecta continues to move ahead with its insulin patch pump.. submitting a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. This is a disposable pump for people with type 2 diabetes. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study. Henry Anhalt, chief medical officer, says nine out of 10 people with diabetes live with type 2 diabetes. However, Anhalt says the majority of automated insulin delivery systems cater to those with type 1 diabetes. Embecta aims to offer more options and tools to the broader diabetes care community, he says.   https://www.drugdeliverybusiness.com/embecta-submits-insulin-patch-pump-fda/ XX Update on insulin prices.. as a few prices changes went into affect at the beginning of the year. So, what took effect this month was that Sanofi followed suit with Eli Lilly and Novo Nordisk to implement this cap on insulin co-pays at $35 that took effect January 1. And that comes after the provisions of the Inflation Reduction Act capped insulin for people on Medicare at $35. The Medicare cap is automatic and part of policy. For everyone with commercial insurance, the cap is voluntary from the companies. For those without government or private insurance, the picture is more complicated. If your insulin is still more than $35 per month, ask your pharmacist for coupons or check out getinsulin dot org. https://www.pbs.org/newshour/show/new-law-caps-insulin-prices-for-some-with-diabetes-but-cost-remains-high-for-millions   XX       Commercial XX XX Young adults who reported higher stress during their teenage years to adulthood were more likely to have high blood pressure, obesity and other cardiometabolic risk factors than their peers who reported less stress, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association. Cardiometabolic risk factors often occur together and are a significant cause of cardiovascular disease. These include obesity, Type 2 diabetes or prediabetes, high cholesterol and high blood pressure, researchers noted. In 2020, cardiometabolic diseases, including cardiovascular diseases and Type 2 diabetes, were the most prevalent chronic health conditions and collectively accounted for nearly a quarter of all deaths in the U.S., according to the American Heart Association statistics. In 2023, the American Heart Association noted the strong connections among cardiovascular disease, kidney disease, Type 2 diabetes and obesity, and suggested redefining cardiovascular risk, prevention and management.   https://finance.yahoo.com/news/childhood-stress-linked-higher-risk-100000670.html XX Shout out to NBC News for a great story they did recently on LADA – featuring two women who have both been on this podcast. Dr. Phyllisa DeRoze and Mila Clark were both first misdiagnosed with type 2 before they got a correct diagnosis of LADA. I'll link up the NBC story along with our chats with both women.. thanks to Mila for giving me a mention as one of the voices in the diabetes community who made her think was she had might not be type 2.. but could be LADA. https://www.nbcnews.com/health/diabetes/diagnosed-type-2-diabetes-may-different-form-disease-rcna132571     XX Join us again soon!

Real-Time Real Talk by Dexcom
CGM + GLP-1s: A Dynamic Duo for Diabetes Management

Real-Time Real Talk by Dexcom

Play Episode Listen Later Jan 17, 2024 31:53


GLP-1 medications have been around since early 2000s but only recently started getting more media coverage, thanks to celebrities and influencers. In this episode of Real-Time, Real Talk host Cher Pastore speaks to acclaimed Timothy Gilbert, MD, a clinical endocrinologist with over 15 years of experience in diabetes management. He has a practice in Louisiana where he and his team, including physicians, nurses, dieticians, and diabetes care and education specialists see many patients every day. Dr Gilbert will demystify this extremely popular weight loss drug, explain the clinical indications for use, when it is beneficial for the patient, and in what scenario GLP-1 may or may not be the best choice. Using examples from his practice, he will answer the question we all been waiting for: how does CGM and GLP-1 medication work together, and what key role CGM plays in optimizing therapy. Cher says this is her favorite episode to date, so definitely not one to be missed! Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide (https://bit.ly/3MSkRUv). For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Timothy R Gilbert, MD is a paid spokesperson for Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. Dexcom Provider website: https://provider.dexcom.com/ Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries.

Diabetech - Diabetes Tech, News, and Management
Dexcom's New 15-Day CGM & G7 Connectivity Updates

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Jan 15, 2024 21:08


I spoke with Dexcom about its latest cgm called Stelo designed for people with type 2 diabetes. I also got more information on Dexcom G7 direct to watch and connectivity.   Join Patreon for Exclusive Content   Fill out T1D Exchange Registry    Follow for more: Instagram | Tik Tok | YouTube | Facebook   Watch Video Podcast on Youtube    DISCLAIMER: This podcast is not medical advice. Always consult with your doctor before making changes to your health care.

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

To celebrate the end of 2023, hosts recap the top 10 episodes of the past year and offer perspective on how the news discussed in these episodes has shaped the future of diabetes management. Episode Highlights 00:32 Automated Insulin Delivery News in October 2023 04:35 Breaking Down AACE's New Type 2 Diabetes Management Algorithms 06:45 What Medicare Drug Price Negotiations Mean for Diabetes  09:15 STEP-HFpEF Reaction  12:10 Dexcom G7 and the Future of CGM, with Jake Leach 13:20 Tandem Mobi and Welldoc's BlueStar Platform 16:20 Making Sense of Semaglutide in Type 1 Diabetes 18:35 Establishing Time in Range as a Primary Glucose Metric 21:15 TRANSITION-T2D, with Paloma Rodriguez, MD, and Kevin Pantalone, DO  25:15 What to Know about the iLet Bionic Pancreas

ReInvent Healthcare
What You Need To Know About CGMs

ReInvent Healthcare

Play Episode Listen Later Dec 20, 2023 21:17


In today's episode, I talk about a device that is reshaping the landscape of personal health — Continuous Glucose Meters (CGMs). Join me as I go over the importance of CGMs and their impact on the lives of our clients. From monitoring glucose levels to unveiling crucial insights into metabolic health, I explore how CGMs are not just devices but catalysts for positive change. So let's dive in and discover the transformative power of CGMs together.IN THIS EPISODE:Importance of Continuous Glucose Meters (CGMs)Continuous Glucose Meters (CGMs) play a crucial role as valuable tools in monitoring glucose levels continuously, especially considering that 93% of the population exhibits signs of metabolic illness, indicating issues with glucose and insulin regulation. The significance lies in the ability to monitor glucose to address potential health challenges, ranging from common issues like excess belly fat and fatigue to more severe conditions such as kidney problems and cardiovascular issues. Therefore, the continuous tracking provided by CGMs is essential for understanding and managing the metabolic health of our clients.How and Where to Get CGMsCGMs, exemplified by brands like Dexcom and Abbott Freestyle Libre, are devices affixed to the arm or belly to monitor glucose levels continuously. Multiple companies manufacture CGMs, and practitioners can recommend these devices for their clients. There are various CGM models, such as Dexcom G6, Freestyle Libre 2, and the more recent Dexcom G7 available. While encountering resistance in prescribing through conventional means, there are alternative avenues for you and your clients to acquire CGMs, including online pharmacies and third-party companies, expanding accessibility to these valuable monitoring tools.CGM Issues and HesitationsAlthough CGMs are revolutionary tools in managing and understanding metabolic health, like any technology, they come with certain issues and concerns. One primary concern revolves around the perceived pain associated with CGM insertion. While the devices are designed to be relatively painless, users may still experience initial discomfort or apprehension. Financial considerations also play a role, with some individuals facing challenges in covering the costs of CGMs. However, solutions such as exploring coupons or prescription assistance programs can help alleviate this concern. Integrating CGMs into daily life activities, like showering or swimming, raises questions about the devices' durability and practicality. While addressing these concerns, the podcast emphasizes the importance of educating users on calibrating and spot-checking for accuracy, offering insights into optimizing CGM use. Additionally, privacy and data security concerns arise, prompting a need for individuals to understand how their data is handled and stored. Important ReInvent Healthcare Links Access Additional Resources for Practitioners ready to improve clinical outcomes through our Nutritional Endocrinology Practitioner Training. Visit the ReInvent Healthcare site to check out other podcast episodes and resources to support you in empowering your clients health recovery journeysCheck out my Insulin Resistance Course here. Learn more about Theia Health here.

Real-Time Real Talk by Dexcom
Unleashing the Power of Partnerships: Tandem Control IQ & Dexcom G7

Real-Time Real Talk by Dexcom

Play Episode Listen Later Dec 20, 2023 22:12


In this episode of Dexcom's Real Time Real Talk, we're speaking to Tandem's Medical Director, Jordan Pinsker. Jordan is a pediatric endocrinologist by training, but has been involved in clinical trials and the development of automated insulin delivery products for many years. Our second guest is Kristy Castillo, the clinical solutions manager at Tandem who is also a nurse, diabetes educator and  lives with type one diabetes herself.   We'll discuss Tandem products including the sleek new number 1 one rated AID system, the t:slim X2 insulin pump, we'll talk about how it integrates with the Dexcom G6 and G7 and Kristy also shares her first-hand experience of using it.   Finally we'll discuss the advantages of connecting your AID system to your smartphone where possible, not just for those with diabetes but also for health care professionals. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Dr Jordan Pinsker and Kristy Castillo are employees of Tandem Diabetes Care. About Tandem Diabetes Care: https://www.tandemdiabetes.com/en-gb/home Warning: Do not use the Dexcom G7 CGM System or the Dexcom G6 System if you are on dialysis. The performance of these CGM systems has not been evaluated in this population and sensor readings may be inaccurate. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. Dexcom Provider website: https://provider.dexcom.com/ Tandem Control IQ Clinical Evidence: https://www.tandemdiabetes.com/en-gb/home References: 1. Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther. 2021 Sep;23(9):601-608. doi: 10.1089/dia.2021.0097. Epub 2021 Apr 21. PMID: 33784196; PMCID: PMC8501470. 2. Roy W. Beck, Lauren G. Kanapka, Marc D. Breton, Sue A. Brown, R. Paul Wadwa, Bruce A. Buckingham, Craig Kollman, and Boris Kovatchev.A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72.Diabetes Technology & Therapeutics.May 2023.329-342.http://doi.org/10.1089/dia.2022.0558 3. S.A. Brown, B.P. Kovatchev, D. Raghinaru, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes N Engl J Med 2019;381:1707-17. DOI: 10.1056/NEJMoa1907863 4. Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP; iDCL Trial Research Group. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736. PMID: 32846062; PMCID: PMC7920146. 5. Marc D. Breton and Boris P. Kovatchev One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology, Diabetes Technology & Therapeutics 2021 23:9, 601-608 6. Boris P. Kovatchev, Harsimran Singh, Lars Mueller, Linda A. Gonder-Frederick; Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis. Diabetes Care 1 November 2022; 45 (11): 2636–2643. https://doi.org/10.2337/dc22-1217

Diabetech - Diabetes Tech, News, and Management
Tandem's Future Tubeless Pump, Mobi & Dexcom G7 Support

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Dec 18, 2023 37:07


I speak with Liz Gasser, Tandem's EVP and Chief Strategy Officer, about Dexcom G7 support, Mobi's launch and functionality, and Tandem's upcoming tubeless pump called Sigi. Let us know what you're most excited about in the comments!   Today's Sponsors: Download Gluroo: iOS | Android Fill out T1D Exchange Registry    Follow for more: Instagram | Tik Tok | YouTube | Facebook    Watch Video Podcast on Youtube     More on Tandem's Tubeless Pump    DISCLAIMER: This podcast is not medical advice. Always consult with your doctor before making changes to your health care.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Arthritis drug studied for T1D, calls to poison control over Ozempic, Tandem Source released, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Dec 15, 2023 14:12


It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: an existing drug for arthritis is being studied for treatment of T1D, poison control centers report a big increase in calls about misdosing of Ozmepic and semaglutides, Tandem releases it's Tandem Source software, we've got an update on a possible non invasive glucose monitoring system, ADA releases it's standards of care and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark XX Our top story this week… XX A world-first clinical trial has found a common drug used to treat rheumatoid arthritis can suppress the progression of type 1 diabetes in recently diagnosed patients. Australian reserachers say they've discovered that baricitinib *bare-uh-sit-en-ub* can preserve the body's own insulin production. The scientists recruited 91 people, aged between 10 and 30 years old, to take part in the double-blind randomised trial. All patients had been diagnosed with type 1 diabetes within the last 100 days and continued with their prescribed insulin therapy throughout the study. The results showed those in the baricitinib group were able safely and effectively to preserve their body's own insulin production and suppress the progression of type 1 diabetes. "Our trial showed that, if started early enough after diagnosis, and while the participants remained on the medication, their production of insulin was maintained. "People with type 1 diabetes in the trial who were given the drug required significantly less insulin for treatment." Dr Faye Riley, research communications manager at Diabetes UK, said of the latest trial: "These findings show by tackling the root of type 1 diabetes - an immune system attack - an existing drug can help to shield the pancreas, in people recently diagnosed with type 1, so they can continue making more insulin for longer. "This can give people with type 1 diabetes much steadier blood sugar levels and help to protect against serious diabetes complications down the line. "Immunotherapies are edging us towards a new era in type 1 diabetes treatment, and could help us overcome a major hurdle en route to finding a cure for the condition. "This trial takes us another step closer." The study was funded by JDRF, a non-profit organization which focuses on type 1 diabetes research. The research has been published in the New England Journal of Medicine. https://news.sky.com/story/world-first-trial-finds-arthritis-drug-may-help-treat-type-1-diabetes-13024706 XX Earlier this month, Dexcom's G7 became compatible with two pump systems: Beta Bionic's ilet pump and Tandem Diabetes tslim X2. Current customers should have received instructions on how to download the updated software – new pumps will be shipped with G7 software already loaded. Tandem has also announced their new Tandem Source platform – full launch in the US with international rollout slated for next year. Anyone in the U.S. who uses a Tandem pump—as well as their respective healthcare providers—will now have access to the Source platform. On the patient side, insulin dosage data will automatically transfer from the pump to the platform, by way of the t:connect mobile app, where it'll be compiled into three reports for your doctor. Patients will also be able to use the platform to access new software updates for their pumps and to reorder supplies as needed. Long term, the company hopes to use the data from users – which would be blinded- to update automated insulin dosing algorithms. https://www.fiercebiotech.com/medtech/tandem-begins-full-us-rollout-source-diabetes-management-platform XX New look at benefits from a plant based diet – this research says it can reduce the risk of type 2 diabetes by 24%. It's not just about weight loss. They reviewed data on more than 113,000 participants in a large-scale British observational study, gathered over 12 years. They found that normal values for cholesterol, blood sugar, inflammation, and insulin are associated with a low risk of diabetes. They also found that good liver and kidney function is important in diabetes prevention. A plant based diet helped with all of those factors. The researchers do point out that there is such a thing as an unhealthy plant-based diet. Those that are still high in sweets, refined grains and sugary drinks are associated with an increased risk of type 2 diabetes, researchers found. https://www.usnews.com/news/health-news/articles/2023-12-13/plant-based-diets-cut-diabetes-risk-by-24 XX Reports of more patients with type 2 diabetes having trouble getting coverage for medication like Ozempic and Mounjaro – because health insurance companies are putting new restrictions in place. Most U.S. health plans cover GLP-1s for type 2 diabetes but many providers will prescribe it off label for weight loss. There is another medication – Wegovy – approved for weight loss, it's the same drug as Ozempic just packaged in a difference dose and name. The average number of weekly Ozempic prescriptions rose 33% between the first and third quarters of this year, but has since dropped more than 6% to about 431,000, according to Iqvia Institute for Data Science. Doctors and patients are bracing for changes in January, when individual health plans often set new coverage terms. "It may be that January 1, all of a sudden something that was covered is no longer," said Dr. Robert Gabbay, chief science officer at the American Diabetes Association. https://www.reuters.com/business/healthcare-pharmaceuticals/us-diabetes-patients-face-delays-insurers-tighten-ozempic-coverage-2023-12-12/ XX Poison control centers across the US say they are seeing a steep increase in calls related to semaglutide, with some people reporting symptoms related to accidental overdoses. From January through November, the America's Poison Centers reports nearly 3,000 calls involving semaglutide, an increase of more than 15-fold since 2019. In 94% of calls, this medication was the only substance reported. The compounded versions of semaglutide are often different from the patented drug. Many contain semaglutide salts called semaglutide sodium and semaglutide acetate. The FDA says the salt forms of the drug have not been tested and approved to be safe and effective the way the patented form of the medication has, and thus they don't qualify for the compounding exemption in the law for drugs in shortage. In other cases, the compounded versions are sold in unapproved dosages. But these compounded versions are popular because they may cost less out-of-pocket, especially if the treatment isn't covered by insurance. The name-brand drugs are sold in pre-filled pens, which come with some safeguards. Patients dial to the correct dose and click to inject, so it's harder to make mistakes. Compounded versions, however, typically come in multidose glass vials, and patients draw their own doses into syringes. It's easy to get confused. https://www.cnn.com/2023/12/13/health/semaglutide-overdoses-wellness/index.html XX XX Type 2 diabetes patients who received endocrinology care through telehealth alone had poor glycemic outcomes compared with those who received in-person or hybrid care, which contrasts with prior research findings, according to a new study. Previous research has shown that telehealth is effective in improving glycemic control, but there has not been enough data on utilization and outcomes linked to routine telehealth care for type 2 diabetes since 2020, especially in the endocrinology setting, the researchers wrote. One reason may be that the strategies to support glycemic improvement deployed during in-person appointments, like self-management education and sharing home blood glucose data, have not been consistently translated to telehealth. “Implementation of approaches to overcome these differences, such as team-based virtual care and technological tools to automate blood glucose data sharing, are needed to ensure all patients receive high-quality diabetes care regardless of care modality,” they wrote. These study findings contrast with previous research, including a study published in early 2022 that revealed that telehealth maintained quality of care and led to better health outcomes for patients with type 2 diabetes during the COVID-19 pandemic. The study included 16,588 with type 2 diabetes who received care before or during the pandemic, with 7,581 having a telehealth visit with either a primary care physician or an endocrinologist. https://mhealthintelligence.com/news/telehealth-only-care-fails-to-improve-type-2-diabetes-outcomes XX Medtronic's deal to buy a South Korea based insulin patch pump maker is off. Back in May Medtrnoic announced a 738-million dollar deal to buy EOFlow, which makes EOPatch, a tubeless, wearable and fully disposable insulin delivery device. EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device for U.S. FDA clearance in January. https://www.massdevice.com/medtronic-nixes-738m-deal-for-insulin-patch-pump-maker-eoflow/ XX Commercial XX Update on non invasive continuous glucose monitoring. The most recent validation of the technology's accuracy has been released as a preprint. In an experiment, researchers fed thousands of radio frequency glucose readings into a machine learning model to translate them into blood sugar values and compared the results against those from a Dexcom G6. CGM accuracy is judged by mean absolute relative difference, or MARD. The statistic is reported as a percentage: a MARD of 10 percent, for example, means that the CGM is on average within 10 percent of the reference value. The Bio-RFID system scored a MARD of 11.27 percent. In truth, this result is difficult to interpret. Though Bio-RFID's MARD is not yet in the same neighborhood as its competitors' (the Freestyle Libre 3 and the Dexcom G7 report MARDs of 7.9 percent and 8.7 percent, respectively), the experiment wasn't a true test of the device's capabilities, because it didn't use a lab-drawn glucose measurement as its reference value. The volunteers also did not have diabetes, which meant that their blood sugar levels were likely more stable than those of most future customers. The FDA has specific accuracy standards that it expects CGM manufacturers to meet for devices intended for “nonadjunctive” use and for use in a closed-loop insulin pump system. Know Labs's product will need to meet these objective standards to be validated as a truly reliable CGM. The Path to Approval “Our expectation is that we'll be in front of the FDA as we move into the second half of 2024,” says Erickson. Much larger trials will be needed to show that the device works and meets FDA standards. Erickson says, “We expect to have an FDA-cleared device in 2025.” Though the business is still finalizing the form of the next generation, it expects that it can navigate the FDA approval process quickly. The FDA has already confirmed that RFID is quite safe and there should be little worry about side effects (though there could be a hazard of interference for patients already using electronic medical devices such as pacemakers). https://www.diabetesdaily.com/blog/this-company-is-racing-to-create-the-worlds-first-non-invasive-cgm-718069/ XX Today, the American Diabetes Association® (ADA) released the Standards of Care in Diabetes—2024 (Standards of Care), a set of comprehensive and evidence-based guidelines for managing type 1, type 2, gestational diabetes, and prediabetes based on the latest scientific research and clinical trials. It includes strategies for diagnosing and treating diabetes in both youth and adults, methods to prevent or delay type 2 diabetes and its associated comorbidities like cardiovascular disease (CVD) and obesity, and therapeutic approaches aimed at minimizing complications and enhancing health outcomes. "The latest ADA guidelines present pivotal updates for health care professionals, ensuring comprehensive, evidence-based care for diabetes management. These changes reflect our ongoing commitment to optimizing patient outcomes through informed, adaptable, and patient-centered health care practices,” said Robert Gabbay, MD, PhD, the ADA's chief scientific and medical officer. “The ADA's Standards of Care ensures health care professionals, especially our primary care workforce, provide the best possible care to those living with diabetes.” Notable updates to the Standards of Care in Diabetes─2024 include: New updates in managing obesity in people with diabetes, including approaches to reduce therapeutic inertia, support more personalization, and incorporate additional obesity measurements beyond body mass index (i.e., waist circumference, waist-to-hip ratio, and/or waist-to-height ratio). New screening recommendations for heart failure in people with diabetes. Updated recommendations for peripheral arterial disease (PAD) screening in people with diabetes. Guidance on screening and the use of teplizumab, approved to delay the onset of type 1 diabetes. More guidance on the use of new obesity medications, glucagon-like peptide 1 (GLP-1) agonists or dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, to reach sustained weight management goals. Updates in guidance on the diagnosis and classification of diabetes. A focus on hypoglycemia prevention and management. Emphasis on screening people with diabetes for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis at primary care and diabetes clinics. New emphasis on the evaluation and treatment of bone health and added attention to diabetes-specific risk factors for fracture. A focus on screening and management of people with diabetes and disability. Emphasis on enabling health care providers to master diabetes technology, using artificial intelligence for retinal screenings with necessary referrals, and embracing telehealth and digital tools for diabetes self-management education. New information on the possible association between COVID-19 infections and new onset of type 1 diabetes. "As the ADA's chair of professional practice committee, I'm excited to share our latest updates to advance diabetes care through new scientific insights and technological innovation, all aimed at enhancing experience for people with diabetes and health care professionals in managing this complex condition," said Nuha A. El Sayed, MD, MM Sc, the ADA's senior vice president of health care improvement. Other noteworthy changes to the 2024 Standards of Care include: Updated immunization guidance to include newly approved RSV vaccines in adults over 60 years of age with diabetes. New emphasis on cultural sensitivity in diabetes self-management education, with considerations for changing reimbursement policies. More detail and emphasis on psychosocial screening protocols to better identify diabetes distress. The importance of diabetes technology, with an emphasis on continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems. Continued emphasis on inclusion and person-centered care. “At the ADA, we are focused on improving the quality of care for anyone who lives with diabetes, prediabetes, or who is at risk of developing diabetes. The Standards of Care is critical to ensuring the improved treatment of diabetes, a chronic disease that requires continuous care through a well-informed and coordinated health care team. These standards equip health care professionals with the gold standard in diabetes care, ensuring the highest level of service and knowledge in the field,” said Chuck Henderson, the ADA's chief executive officer. The ADA annually updates its Standards of Care through the efforts of its Professional Practice Committee (PPC). Comprising 21 global experts from diverse professional backgrounds, the PPC includes physicians, nurse practitioners, certified diabetes care and education specialists, registered dietitians, pharmacists, and methodologists. Its members hold expertise in areas like adult and pediatric endocrinology, epidemiology, public health, cardiovascular risk management, kidney disease, microvascular complications, preconception and pregnancy care, weight management, diabetes prevention, behavioral and mental health, inpatient care, and technology in diabetes management. Additionally, the committee collaborates with 19 specialized content experts. The 2024 Standards of Care has garnered endorsements from the American College of Cardiology (Section 10), the American Society of Bone and Mineral Research (Bone section in Section 4), and the Obesity Society (Section 8). Today, the Standards of Care in Diabetes—2024 is available online and is published as a supplement to the January 2024 issue of Diabetes Care®. A shortened version of the guidelines, known as the Abridged Standards of Care, will be made available for primary care providers in the journal Clinical Diabetes®, along with a convenient Standards of Care app as well as a Standards of Care pocket chart. The online version will be annotated in real-time with necessary updates if new evidence or regulatory changes merit immediate incorporation through the “living” Standards of Care process. Other Standards of Care resources, including a webcast with continuing education (CE) credit and a full slide deck, can be found on the ADA's professional website, DiabetesPro®. https://diabetes.org/newsroom/press-releases/american-diabetes-association-releases-standards-care-diabetes-2024 XX Join us again soon!  

Fast Five Medtech News Podcast
Tandem integrates Dexcom G7 into insulin pumps, Medtronic wins CE mark for neurostim tech

Fast Five Medtech News Podcast

Play Episode Listen Later Dec 7, 2023 9:14


Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, Dec. 7, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Merit Medical upsized a private placement to $650 million and could bring in as much as $725 million from the offering. Fast Five hosts Jim Hammerand and Sean Whooley look at the details of the offering, as well as Merit's potential plans with the proceeds. The hosts look at a major reimbursement win for Ambu, breaking down some of the features of the company's single-use bronchoscope technology and why CMS decided to allow incremental reimbursement for outpatient procedures. Levita Magnetics announced the completion of the first procedures outside the U.S. with its surgical robotic technology. Hear all about the magnetic-based MARS platform, the surgeries that took place in South America and what this milestone means to Levita's CEO. Medtronic earned CE mark for the latest device in its Precept family of deep brain stimulation implants. While it remains investigational in the U.S., the hosts look at what this implant brings to the European market as a first-of-its-kind offering. In a milestone announcement for diabetes technology, Tandem Diabetes Care and Dexcom say they launched an integrated artificial pancreas system using Tandem's pump technology and Dexcom's next-generation G7 CGM. Whooley and Hammerand explain the significance of this integration and the benefits for users of the technology.

Real-Time Real Talk by Dexcom
Mastering CGM: Real Stories and Expert Tips for Seamless Glucose Monitoring

Real-Time Real Talk by Dexcom

Play Episode Listen Later Oct 3, 2023 52:59


In the latest episode of Real Time Real Talk, we engage in an enlightening conversation on the progressive strides in diabetes management with our special guest, Dr. Nicholas Argento. With personal experience spanning over five decades of living with type one diabetes and leveraging his professional expertise in diabetes technology, Dr. Argento details the indispensable role that CGM plays in his life from diagnosis in 1968, the evolution of glucose monitoring, ie. From insulin to now integrating CGM with an automated insulin delivery devices and what the future could hold. In this insightful discussion, Dr. Argento also offers his first-hand experience with the Dexcom G6 device, drawing parallels between CGM and a personal GPS for glucose. He elaborates on the downside of the traditional finger sticks method of monitoring blood glucose levels and champions the CGM as a significant milestone in diabetes management. He also shares actionable strategies for dietary adjustments and lifestyle modification, emphasizing the link between diet, light exercises, and effective blood glucose level management. This is a fantastic episode with great takeaways, not just for those living with diabetes but also health care professionals. This episode was recoded at ADA - The American Diabetes Association in July 2023. Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Dr. Nicholas Argento MD, PhD is a paid spokesperson for Dexcom. About Hello Dexcom Dexcom Provider website Warning: Do not use the Dexcom G7 CGM System or the Dexcom G6 System if you are on dialysis. The performance of these CGM systems has not been evaluated in this population and sensor readings may be inaccurate. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther. 2021 Sep;23(9):601-608. doi: 10.1089/dia.2021.0097. Epub 2021 Apr 21. PMID: 33784196; PMCID: PMC8501470. 2. Tadej Battelino, et al; Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care 1 August 2019; 42 (8): 1593–1603. https://doi.org/10.2337/dci19-0028

Real-Time Real Talk by Dexcom
A Dynamic Duo: Dexcom & Omnipod

Real-Time Real Talk by Dexcom

Play Episode Listen Later Sep 12, 2023 37:44


Join us for an insightful journey into the world of diabetes management technology on this very special episode of Real-Time, Real Talk. Recorded live from the American Diabetes Association's 83rd Scientific Sessions in San Diego, host Nancy Hanna is joined by Dexcom's Cher Pastore in our very first simulcast. To explore how Dexcom and Omnipod are influencing the dynamics of diabetes technology and reshaping patient outcomes for the better, they're joined by Dr. Viral Shah - an endocrinologist whose research into these innovative therapies has touched and improved countless lives. Across the episode, you'll discover how technological advancements are changing the game and reducing daily management burdens for people with diabetes. Hear invaluable insights from Dr. Shah on the importance of early adoption of tools and how they can prove pivotal in managing diabetes and improving glycemic control. Dr Shah examines the different barriers to technology adoption, and how fostering a pro-active conversation can help overcome them. All this, plus a sneak peek into the future of diabetes tech. Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G6 User Guide (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://dexcompdf.s3.us-west-2.amazonaws.com/en-us/G6-CGM-Users-Guide-new.pdf). For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G6 app or receiver before making treatment decisions. Dr. Viral Shah MD, is a paid spokesperson for Dexcom. About Hello Dexcom (https://provider.dexcom.com/prescribe-sample#block-contactus) Dexcom Provider website (https://provider.dexcom.com/) Warning: Do not use the Dexcom G7 CGM System or the Dexcom G6 System if you are on dialysis. The performance of these CGM systems has not been evaluated in this population and sensor readings may be inaccurate. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G6 Continuous Glucose Monitoring System (G6) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G6 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Sue A. Brown, et al, Omnipod 5 Research Group; Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 1 July 2021; 44 (7): 1630–1640. https://doi.org/10.2337/dc21-0172 2. Champakanath A, Akturk HK, Alonso GT, Snell-Bergeon JK, Shah VN. Continuous Glucose Monitoring Initiation Within First Year of Type 1 Diabetes Diagnosis Is Associated With Improved Glycemic Outcomes: 7-Year Follow-Up Study. Diabetes Care. 2022 Mar 1;45(3):750-753. doi: 10.2337/dc21-2004. 3. Mulinacci G, Alonso GT, Snell-Bergeon JK, Shah VN. Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):6-10. doi: 10.1089/dia.2018.0257. 4. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52464&ver=49&contractorName=all&sortBy=updated&bc=13 5. Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy. Diabetes Care. 2023 Apr 1;46(4):742-750. doi: 10.2337/dc22-1915. 6. Davis GM, et al. Automated Insulin Delivery with Remote Real-Time Continuous Glucose Monitoring for Hospitalized Patients with Diabetes: A Multi-Center, Single-arm, Feasibility Trial. Diabetes Technol Ther. 2023 Aug 14. doi: 10.1089/dia.2023.0304.

Real-Time Real Talk by Dexcom
Beta Bionics iLet – The Ultimate Game Changer in Diabetes Care

Real-Time Real Talk by Dexcom

Play Episode Listen Later Aug 23, 2023 54:57


In this month's episode of Dexcom's ‘Real Time Real Talk', host Cher Pastore talks to Beta Bionic's Chief Medical Officer, Dr. Steven Russell about the iLet Bionic Pancreas - the revolutionary automated insulin delivery system from ADA - The American Diabetes Association held in San Diego. The iLet has been years in the making with Dr Ed Damiano, Beta Bionic's founder starting this journey when his son was diagnosed with T1 diabetes aged just 11 months, to back in May when Beta Bionics have announced FDA Clearance and Commercialization of the iLet. Founded in 2015 explicitly to be a force for good for the diabetes community, the iLet ticks that box as it reduces the need to make decisions about your diabetes management – as it makes the decisions for you. No more carb counting, carb ratios, correction factors or pre-set Basal rates, How does it do that? By using a few algorithms: Basal, corrections and meal dose, and all you need to do to get started is to put your body weight in! Topics discussed in this episode include the journey of how the iLet came to be and how it differs from other automated insulin delivery systems in that it solves two notable challenges that have long burdened both type 1 diabetics and healthcare providers — carbohydrate counting and pre-bolusing. Dr Russell also discusses some of the findings from the extensive pivotal trials that took place, how the iLet is working with the Dexcom G6, some findings from the targeted initial launch and the roadmap Beta Bionics are planning for the future of the iLet. Whether you're using the iLet, want to use it or are a Health Care Provider, this episode is not one to miss out. Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide (https://dexcompdf.s3.us-west-2.amazonaws.com/en-us/G7-CGM-Users-Guide.pdf). For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. In this month's episode of Dexcom's ‘Real Time Real Talk', host Cher Pastore talks to Beta Bionic's Chief Medical Officer, Dr. Steven Russell about the iLet Bionic Pancreas - the revolutionary automated insulin delivery system from ADA - The American Diabetes Association held in San Diego. The iLet has been years in the making with Dr. Ed Damiano, Beta Bionic's founder starting this journey when his son was diagnosed with T1 diabetes aged just 11 months, to back in May when Beta Bionics have announced FDA Clearance and Commercialization of the iLet. Founded in 2015 explicitly to be a force for good for the diabetes community, the iLet ticks that box as it reduces the need to make decisions about your diabetes management – as it makes the decisions for you. No more carb counting, carb ratios, correction factors or pre-set Basal rates, How does it do that? By using a few algorithms: Basal, corrections and meal dose, and all you need to do to get started is to put your body weight in! Topics discussed in this episode include the journey of how the iLet came to be and how it differs from other automated insulin delivery systems in that it solves two notable challenges that have long burdened both type 1 diabetics and healthcare providers — carbohydrate counting and pre-bolusing. Dr. Russell also discusses some of the findings from the extensive pivotal trials that took place, how the iLet is working with the Dexcom G6, some findings from the targeted initial launch and the roadmap Beta Bionics are planning for the future of the iLet. Whether you're using the iLet, want to use it or are a Health Care Provider, this episode is not one to miss out. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Dr. Steven Russell MD, PhD is a Chief Medical Officer of Beta Bionics. About Hello Dexcom: https://provider.dexcom.com/prescribe-sample#block-contactus Dexcom Provider website: https://provider.dexcom.com/ About Beta Bionics: https://www.betabionics.com/ Warning: Do not use the Dexcom G7 CGM System or the Dexcom G6 System if you are on dialysis. The performance of these CGM systems has not been evaluated in this population and sensor readings may be inaccurate. BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Lynch J, Kanapka LG, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Calhoun P, Beck RW. The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):726-736. doi: 10.1089/dia.2022.0341. PMID: 36173238; PMCID: PMC9529297. 2. Beck RW, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Li Z, Calhoun P. A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):681-696. doi: 10.1089/dia.2022.0167. PMID: 36173235; PMCID: PMC9529301. 3. Kruger D, Kass A, Lonier J, Pettus J, Raskin P, Salam M, Trikudanathan S, Zhou K, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Li Z, Marak MC, Calhoun P, Beck RW. A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):697-711. doi: 10.1089/dia.2022.0200. PMID: 36173236; PMCID: PMC9634987.

This is Type 1: Real-Life Type 1 Diabetes
MVP - CGM Manufacturers

This is Type 1: Real-Life Type 1 Diabetes

Play Episode Listen Later Jul 25, 2023 44:31


Our follow-up episode to the discussion on insulin pumps, this MVP discusses the different CGM manufacturers and what we knew at the time for what was coming. Since the original episode aired, the Dexcom G7 has been released, but is (as of summer 2023) still undergoing integration with the Tandem t:Slim X2 insulin pump. Knowing about the different CGM options is just as important (if not more important) than knowing what pumps are out there. If I had to choose between a pump and a sensor, I'd choose a sensor every time.Information is potential power, and you can't make a decision about which CGM to use if you don't know the options. Join the Half-Dead Pancreas Club! What to do next... Leave a review on Apple Podcasts Join the Half-Dead Pancreas Club Follow the Pod on Instagram Follow Colleen on Instagram Follow Jessie on Instagram Follow us on TikTok

Real-Time Real Talk by Dexcom
Digital Health & Dexcom: The Role of CGM in Personalized Medicine

Real-Time Real Talk by Dexcom

Play Episode Listen Later Jul 4, 2023 25:47


In this podcast episode, host Cher Pastore speaks with Dr Sushma Reddy, a clinical endocrinologist at Carbon Health, a tech-enabled healthcare company on a mission to make great healthcare accessible by putting people first. Dr Reddy has used CGM for over 20 years and has developed innovative approaches to manage diabetes that incorporate CGM including a boot camp approach to uncontrolled type 2 diabetes, a CGM clinic and a therapeutic CGM training program. As an endocrinologist at Carbon Health, she sees patients completely virtually using a team based approach incorporating CGM. We discuss how the use of CGM and digital platforms can help improve outcomes for patients, she shares stories of patients using CGM and shares insights for other health care providers. Real-time real talk is intended for healthcare professionals in the US. DISCLAIMER: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the: Dexcom G7 User Guide: https://bit.ly/3MSkRUv For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. DEXCOM CLARITY SAFETY INFORMATION: The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. About Hello Dexcom: https://www.dexcom.com/en-us/get-started-cgm/11 Dexcom Provider website: https://provider.dexcom.com/

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Ozempic compound warning, T1D Go Fund Me study, Tandem timeline update.. and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jun 16, 2023 8:59


It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: FDA warning about compounded versions of semaglutides like Wegovy and Ozempic, new research on what people with diabetes who start Go Fund Me campaigns are asking for, Tandem's CEO gives an update on Dexcom G7 and Libre integration, follow-up on the French Open player denied insulin on the court, and more! Here's more info about Mom's Night Out: https://bit.ly/DMomsNightOut Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by Moms Night Out! Treat yourself to some time away with other moms who get it! XX The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain the same ingredients as the prescription products and may not be safe or effective. Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn't say what the problems were. The trouble is that those versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in people. As of May, Ozempic and Wegovy remain on the FDA's list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications. Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said. https://time.com/6284497/fda-warning-ozempic-wegovy/ XX ZVHER-ehv pronounce https://www.youtube.com/watch?v=u8spdvgpIzs French Open organizers reversed their initial decision denying Alexander Zverev access to insulin injections on the court. Initially they said he'd have to do his injections during off-court bathroom breaks, something players are limited to only two of. Zverev has lived with type 1 since he was three years old? And apparently there were complaints after he injected himself during his fourth-round match. Zverev said he was told it didn't look right when he injected himself on the court. “This is not a clever take because if I don't do it, my life will be in danger. But they said it looks weird,” he said. And it prompted a response from type 1 diabetes research charity JDRF. In an open letter, the charity said: “We would like to emphasise that insulin administration is an essential aspect of type 1 diabetes management, and it should be treated with the same respect and understanding as any other medical intervention. “It is critical that athletes with diabetes, like Mr. Zverev, are given the necessary accommodations and support to effectively manage their condition while competing. This includes the ability to administer insulin when required, as recommended by their healthcare professionals.” XX Many people with diabetes in the United States have turned to crowdfunding to pay their medical bills, even though a quarter of patients sampled had insurance, according a new study by Duke University researchers. In the United States, more than 40% of patients with diabetes struggle to pay their medical bills. Among those patients, more than half — 56% — have either delayed or foregone care entirely, Caroline E. Sloan, MD, MPH, a primary care physician at Duke University School of Medicine, and colleagues wrote. One estimate suggested that the average patient who is dependent on insulin and has insurance spends about $4,800 every year on physician visits, supplies, medications, hospitalizations and lost wages — the equivalent to 15% of the median U.S. per capita income. They evaluated 313 GoFundMe campaigns describing patients' medical situations, expenses and fundraising goals. The researchers included an oversampling of type 1 diabetes campaigns so they could have roughly even proportions of type 1 and non-type 1 diabetes campaigns “and ensure a wide breadth of experiences.” Sloan and colleagues found that the median fundraising goal was $10,000, the median amount raised was $2,600, and just 14% of campaigns reached their goal. Additionally, 25% of fundraisers had insurance, but 49% of those who did have insurance said their out-of-pocket costs were still too high. Fewer than 10% requested money specifically for insulin; 48% of direct medical expenses were not directly related to glucose control. When it came to characteristics of campaigns for types of diabetes, they found that 21% of total campaigns — almost all of which were campaigns for type 1 diabetes — requested money for diabetic alert dogs. Campaigns not for type 1 diabetes mentioned indirect medical expenses more often than campaigns for type 1 diabetes: 63% vs. 34%. “Thirty-five percent of patients with type 1 diabetes started fundraising campaigns for diabetic alert dogs, which cost about $15,000 and are not covered by insurance because of high variability in effectiveness,” the researchers wrote. “Clinicians who learn of a patient's intent to purchase a dog could redirect them toward proven management strategies, such as continuous glucose monitors.” https://www.healio.com/news/primary-care/20230613/patients-with-diabetes-are-increasingly-turning-to-gofundme-to-pay-medical-bills XX XX United Healthcare will now cover the Eversense E3 CGM System for people with type 1 diabetes and people with type 2 who use insulin. That's as of July 1. The Eversense E3 CGM is inserted just under the skin and stays there for six months. UnitedHealthcare is the largest health insurance company in the United States https://finance.yahoo.com/news/senseonics-announces-unitedhealthcare-coverage-eversense-110000925.html XX operational and commercial goals we set for this year,” CEO John Sheridan said in a call with investors on Wednesday afternoon. That confidence is helped along in particular by the company's plans for a spate of product expansions and launches later this year. “Overall, there's an enthusiasm at Tandem as we approach being able to offer another wave of innovative products to the diabetes community,” Sheridan said. “With these launches, we'll be building upon our reputation for offering high-quality products and services that reduce the burden of diabetes management.” Among those launches will be the integration of Dexcom's G7 continuous glucose monitor sensor and Abbott's FreeStyle Libre 2 and 3 into Tandem's t:slim X2 insulin pump system, which Sheridan said would make Tandem's device “the first FDA-cleared insulin pump integrated with multiple CGM sensors.” Those additions will come in the form of free, remote software updates, per the CEO, with the first updates slated to begin rolling out in the coming quarters. For each of the three integrated CGMs, Tandem will perform “internal walkabout testing” before adding them to its t:slim system in scaled launches first in the U.S. and then internationally; the process has already begun for Dexcom's G7 and Abbott's Libre 2 sensors, with the Libre 3 on track to be a “fast follow-up” after the previous model's U.S. launch this fall. Sheridan suggested that a “meaningful number of customers” could be using a G7-connected t:slim pump by the third quarter, while the FreeStyle Libre version of the tech should reach that same nebulous milestone in the fourth quarter Alongside the upgrades to its t:slim X2 pump, Tandem is also eyeing an upcoming launch for its new Mobi pump, which is still under FDA review. The pump is about half the size of the t:slim models and can be completely operated via a smartphone app. “Our dialogue with the agency remains constructive as we work through the process of FDA review and responding to questions,” Sheridan said. “In the meantime, we continue to prepare for its launch in the second half of the year.” https://www.fiercebiotech.com/medtech/tandem-plots-h2-launch-slimmed-down-insulin-pump-dexcom-and-abbott-cgm-integration XX XX Researchers at Washington University School of Medicine in St. Louis have identified a process in immune cells that links vitamin D deficiency during pregnancy to an increased risk of Type 2 diabetes in those born from those pregnancies. The research is published June 13 in the journal Nature Communications. Some theories of disease suggest that conditions in utero may have irreversible, lifelong consequences in offspring. The new study's principal investigator, Carlos Bernal-Mizrachi, MD, said that could be happening to the children of mothers who don't have adequate levels of vitamin D during pregnancy. https://www.news-medical.net/news/20230613/Vitamin-D-deficiency-during-pregnancy-linked-to-an-increased-risk-of-Type-2-diabetes-in-offspring.aspx XX In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I've taken the best elements from those events and created a brand new experience. We're going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D. XX Update on non invasive glucose monitoring.. Know Labs says they're in the next stage of their Bio-RFID sensor. Lots of behind the scenes and lab advancements here from what I can tell. But they release says: For 2023, Know Labs remains focused on external validation of its technology and contributing to its growing body of peer-reviewed evidence, which can be found at www.knowlabs.co/research-and-validation. The company will make further refinements to the Gen 1 Device as it works toward realizing its vision for the KnowU and UBand and bringing an FDA-cleared product to the marketplace. https://www.businesswire.com/news/home/20230607005237/en/Know-Labs-Completes-Build-of-Portable-Generation-1-Prototype-for-Non-Invasive-Glucose-Monitoring XX Dexcom focuses on mental heath during the UK Diabetes Awareness Week. They've released a new study showing 84% of people surveyed agree having diabetes can negatively impact mental health. Their news release goes on.. To honor the strength and resilience of the diabetes community, and to promote mental health and connection, Dexcom is encouraging people with diabetes - and their friends and family - to strike a #DexcomWarriorPose by hosting a day of free puppy yoga classes at Puppy Yoga London in Hoxton, London this Saturday 17 June. https://www.businesswire.com/news/home/20230612005039/en/New-Study-Shows-That-84-of-People-With-Diabetes-Struggle-With-Mental-Health1 XX On the podcast next week.. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon. ----

Pancreas Pals
Season 10 Ep. 2: Dexcom G7 vs. Freestyle Libre 3

Pancreas Pals

Play Episode Listen Later Jun 12, 2023 31:25


On Season 10 Episode 2, Emily tells Miriam about her experience with the Dexcom G7 and how it compares to her time using the Freestlye Libre 3 continuous glucose monitors. Hosted on Acast. See acast.com/privacy for more information.

Real-Time Real Talk by Dexcom
"Don't let diabetes define your life": Dexcom Warrior Ariana Frayer on diagnosis, G7 and living with Type 1

Real-Time Real Talk by Dexcom

Play Episode Listen Later Jun 6, 2023 38:38


In this podcast episode, host Cher Pastore speaks with Cup of OJ Founder, Ariana Frayer, who was diagnosed with type 1 diabetes aged 10. Ariana shares her journey, what it was like growing up with diabetes, and how it impacted things like school and dating. We also hear about her unique experience with CGM, what she likes about the G7, the differences from the G6 as well as her favourite features. Lastly, we learn about a community she founded on Instagram and Cup of OJ to pursue her goal of sharing knowledge and inspiring growth, keeping herself accountable for her diabetes whilst uniting others who also share this experience. Real-time real talk is intended for healthcare professionals in the US. DISCLAIMER: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the: Dexcom G7 User Guide: https://bit.ly/3MSkRUv For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products. A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Ariana Frayer is a paid spokesperson and a Dexcom Warrior. BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. DEXCOM CLARITY SAFETY INFORMATION: The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. About Hello Dexcom: https://www.dexcom.com/en-us/get-started-cgm/11 Dexcom Provider website: https://provider.dexcom.com/

Diabetech - Diabetes Tech, News, and Management
The Dexcom G7 So Far and the Future of CGM Technology

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later May 29, 2023 46:24


Pharmacy Podcast Network
What The Expanded CMS Guidelines Mean for your Medicare Patients | Real-Time Real Talk by Dexcom

Pharmacy Podcast Network

Play Episode Listen Later May 15, 2023 29:53


Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information.   Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. About New Expanded Medicare Guidelines About Hello Dexcom   Dexcom Provider website   About Medicaid coverage   Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.   A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries.   Dexcom G7 User Guide Martens T, Beck RW, Bailey R, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin:A Randomized Clinical Trial.  2021;325(22):2262–2272. doi:10.1001/jama.2021.7444 Aleppo G, et al. The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin. Diabetes Care. 2021 Dec;44(12):2729-2737. doi: 10.2337/dc21-1304. Epub 2021 Sep 29. PMID: 34588210; PMCID: PMC8669539. Psavko S, Katz N, Mirchi T, Green CR. Usability and teachability of continuous glucose monitoring devices in older adults and diabetes educators: a task analysis and ease of use survey. JMIR Hum Factors. 2022 Nov 8. doi: 10.2196/42057 International Hypoglycemia Study Group. Diabetes Care. 2015;38:1583-1591. Boureau AS, et al. Nocturnal hypoglycemia is underdiagnosed in older people with insulin-treated type 2 diabetes: The HYPOAGE observational study. J Am Geriatr Soc. 2023;1–13. DOI: 10.1111/jgs.18341. Acciaroli G, Welsh JB, Akturk HK. Mitigation of Rebound Hyperglycemia With Real-Time Continuous Glucose Monitoring Data and Predictive Alerts. J Diabetes Sci Technol. 2022 May;16(3):677-682. doi: 10.1177/1932296820982584. Epub 2021 Jan 5. PMID: 33401946; PMCID: PMC9294577. Puhr S, Derdzinski M, Welsh JB, Parker AS, Walker T, Price DA. Real-World Hypoglycemia Avoidance with a Continuous Glucose Monitoring System's Predictive Low Glucose Alert. Diabetes Technol Ther. 2019 Apr;21(4):155-158. doi: 10.1089/dia.2018.0359. Epub 2019 Mar 22. PMID: 30896290; PMCID: PMC6477579. Shichun Bao, Ryan Bailey, Peter Calhoun, and Roy W. Beck.Effectiveness of Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes Treated with Basal Insulin.Diabetes Technology & Therapeutics.May 2022.299-306.http://doi.org/10.1089/dia.2021.0494 By 2023, there had been 52 million ULS alerts from Dexcom CGM systems, and 11 million of those occurred during the night. Dexcom data on file, 2023.

Real-Time Real Talk by Dexcom
What The Expanded CMS Guidelines Mean for your Medicare Patients

Real-Time Real Talk by Dexcom

Play Episode Listen Later May 15, 2023 29:53


Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individualresults may vary – nothing you hear on this podcast should be considered medical advice. All claims are supportedby clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 UserGuide. For product-related questions, please refer to the instructions for use. For complete safety information, goto dexcom.com/safety-information.Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility.The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucosemonitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has nolimitations for use in pregnancy.About New Expanded Medicare GuidelinesAbout Hello DexcomDexcom Provider websiteAbout Medicaid coverageDexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7.Data from collaborator devices and products must be verified by those collaborator devices and products. Usersshould confirm data and connections with their collaborator devices and products.A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends.CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatmentdecisions.Brief Safety StatementBRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and itscomponents according to the instructions for use provided with your device and available athttps://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings,precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low bloodglucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result ininjury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to makediabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medicalemergency.Dexcom Clarity Safety InformationThe web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals toassist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historicalCGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGMdevices with data interface capabilities. Caution: The software does not provide any medical advice and should notbe used for that purpose. Home users must consult a healthcare professional before making any medicalinterpretation and therapy adjustments from the information in the software. Caution: Healthcare professionalsshould use information in the software in conjunction with other clinical information available to them. Caution:Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional.Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S.,and may be registered in other countries.References1. Dexcom G7 User Guide2. Martens T, Beck RW, Bailey R, et al. Effect of Continuous Glucose Monitoring on Glycemic Control inPatients With Type 2 Diabetes Treated With Basal Insulin: A Randomized ClinicalTrial. JAMA. 2021;325(22):2262–2272. doi:10.1001/jama.2021.74443. Aleppo G, et al. The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2Diabetes Treated With Basal Insulin. Diabetes Care. 2021 Dec;44(12):2729-2737. doi: 10.2337/dc21-1304

Diabetech - Diabetes Tech, News, and Management
Dexcom G7 CEO Interview: Your Questions Answered

Diabetech - Diabetes Tech, News, and Management

Play Episode Listen Later Apr 30, 2023 23:35


I spoke with Dexcom's CEO, Kevin Sayer, about the recently released Dexcom G7 cgm. You sent in questions on social medial and I asked them. I ask about the upcoming direct-to-Apple Watch support, future 15 day wear, and the future of cgm technology.      Subscribe to this podcast for new episodes every Monday.       Follow for more: Instagram | Tik Tok | YouTube | Facebook   Watch Video Podcast on Youtube      This podcast should NOT be considered medical advice. Always consult with your doctor before making changes to health care treatment.

ceo apple watches dexcom dexcom g7 kevin sayer
Pharmacy Podcast Network
Real-Time CGM Use in Pregnancy: A Breakthrough in the Treatment for Your Patients with Diabetes | Real-Time Real Talk by Dexcom

Pharmacy Podcast Network

Play Episode Listen Later Apr 13, 2023 34:42


Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information.   Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Amy Valent, MD is a paid spokesperson for Dexcom and is a guest on this episode of the podcast. About Hello Dexcom   Dexcom Provider website   Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.   A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References Dexcom G7 User Guide Satish K. Garg, MD, et al. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes.Diabetes Technology & Therapeutics.Jun 2022.373 380.http://doi.org/10.1089/dia.2022.0011. Denice S Feig, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial.  

Real-Time Real Talk by Dexcom
Real-Time CGM Use in Pregnancy: A Breakthrough in the Treatment for Your Patients with Diabetes | Real-Time Real Talk by Dexcom

Real-Time Real Talk by Dexcom

Play Episode Listen Later Apr 13, 2023 34:42


Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information.   Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility. The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older. Dexcom G7 has no limitations for use in pregnancy. Amy Valent, MD is a paid spokesperson for Dexcom and is a guest on this episode of the podcast. About Hello Dexcom   Dexcom Provider website   Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.   A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References Dexcom G7 User Guide Satish K. Garg, MD, et al. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes.Diabetes Technology & Therapeutics.Jun 2022.373 380.http://doi.org/10.1089/dia.2022.0011. Denice S Feig, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial.

Keeping It 100 Radio: Uncensored Diabetes Conversations
EP 89: Diabetes Technology: What to Expect in 2023 with Madalyn Vasquez, MS, RD, CDCES

Keeping It 100 Radio: Uncensored Diabetes Conversations

Play Episode Listen Later Mar 27, 2023 43:04


Diabetes technology is constantly evolving - which means there is a lot to keep up with. Omnipod 5, Control IQ, Dexcom G7.. what's there to know? Inside this episode, I sit down with Madalyn Vasquez, MS, RD, CDCES and pump trainer to discuss all the new tech in 2023. Resources for this episode: Follow Madalyn on Instagram: https://instagram.com/diabetes.rd Take our free quiz: http://needlesandspoons.com/quiz-optin Join us inside the Keeping it 100 Diabetes Coaching Experience: https://bit.ly/3E5TX5W Grab the Keeping it 100 Diabetes Journal: https://www.amazon.com/dp/B0BB5ZL6R8?ref_=pe_3052080_397514860 Check out our blog: https://bit.ly/3AkABcm Follow us on Instagram: https://bit.ly/3hMqhU9 Check out our free resource hub: https://bit.ly/3tF2tnC Try Skin Grip and use the code "LISSIE" at skingrip.com Check out our favorite products: https://www.amazon.com/shop/needlesandspoons_?ref=ac_inf_tb_vh *Disclaimer: Nothing inside of Keeping it 100 Radio or our resources is intended as medical advice. Always consult a physician before making changes to your insulin doses, diet or general wellness.

Pharmacy Podcast Network
Introducing Dexcom G7 | Real-Time Real Talk by Dexcom

Pharmacy Podcast Network

Play Episode Listen Later Feb 27, 2023 41:41


Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information.    Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility.  The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older.  Egils Bogdanovics, MD is a paid spokesperson for Dexcom and is a guest on this episode of the podcast. About Hello Dexcom    Dexcom Provider website   Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.   A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional.  Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References Dexcom G7 User Guide Seagrove Partners. The Diabetes Forum: 2021 CGM Market Primer. P26 Psavko S, Katz N, Mirchi T, Green CR. Usability and teachability of continuous glucose monitoring devices in older adults and diabetes educators: a task analysis and ease of use survey. JMIR Hum Factors. 2022 Nov 8. doi: 10.2196/42057. Welsh JB, Psavko S, Zhang X, Gao P, Balo AK. Comparisons of Fifth-, Sixth-, and Seventh- Generation Continuous Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Jun 13:19322968221099879. PMID: 35695305. doi: 10.1177/19322968221099879. Satish K. Garg, MD, et al. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes.Diabetes Technology & Therapeutics.Jun 2022.373 380.http://doi.org/10.1089/dia.2022.0011. Automatically Generated Continuous Glucose Monitoring (CGM) Notifications and Their Association with Glycemic Control Kaushik Shankar, Priscilla Hastedt, Mark Derdzinski, John Welsh, Caleb Barger, Gary Cohen, San Diego, CA, Portland, OR Diabetes 2020;69 (Supplement_1):79-LB Insights from big data (2): Benefits of self-guided retrospective review of continuous glucose monitoring reports. Parker AS, Welsh J, Jimenez A, Walker T. Diabetes Technol Ther. 2018;20(S1):A-27 Denice S Feig, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial.   

Real-Time Real Talk by Dexcom
Introducing Dexcom G7

Real-Time Real Talk by Dexcom

Play Episode Listen Later Feb 27, 2023 41:34


Real-time real talk is intended for healthcare professionals in the US. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information.    Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer. Smart devices are sold separately. For a list of compatible smart devices, visit: dexcom.com/compatibility.  The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons aged 2 years and older.  Egils Bogdanovics, MD is a paid spokesperson for Dexcom and is a guest on this episode of the podcast. About Hello Dexcom    Dexcom Provider website   Dexcom's partners are working to integrate insulin pumps, insulin pens, and digital health apps with Dexcom G7. Data from collaborator devices and products must be verified by those collaborator devices and products. Users should confirm data and connections with their collaborator devices and products.   A separate Follow app and internet connection are required to follow CGM users' glucose readings and trends. CGM users should always confirm glucose readings on the Dexcom G7 app or receiver before making treatment decisions. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom G7 Continuous Glucose Monitoring System (G7) and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose0 or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the G7 do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom Clarity Safety Information The web-based Dexcom Clarity software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional.  Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References Dexcom G7 User Guide Seagrove Partners. The Diabetes Forum: 2021 CGM Market Primer. P26 Psavko S, Katz N, Mirchi T, Green CR. Usability and teachability of continuous glucose monitoring devices in older adults and diabetes educators: a task analysis and ease of use survey. JMIR Hum Factors. 2022 Nov 8. doi: 10.2196/42057. Welsh JB, Psavko S, Zhang X, Gao P, Balo AK. Comparisons of Fifth-, Sixth-, and Seventh- Generatio

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Dexcom G7 launch, cannabis and type 1, Insulet acquisitions and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Feb 17, 2023 7:05


It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Dexcom G7 is now available in the United States, Insulet buys assets from Bigfoot and another California company, new studies about cannabis and type 1 and COVID and diabetes, different predictors of type 2 in women and men, plus scholarships for T1D students. Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode Transcription:  Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by T1D Exchange dedicated to improving outcomes for the entire T1D population XX Our top story. Today's the day. February 17th is the day Dexcom's G7 becomes available in the United States. Now.. whether you can get it still depends on your insurance, your doctor – a new prescription is needed – and the availability at your pharmacy. Whether you want to get it may depend on if you use a compatible pump system – the G7 will NOT work with Tandem's CIQ or Omnipod 5 for several more months. The G7 will be accessible to all Medicare patients with diabetes who meet the eligibility criteria as of today.. so no wait there. Much more to come on the launch I'm sure.. https://investors.dexcom.com/news/news-details/2023/Dexcom-G7-Continuous-Glucose-Monitoring-System-Will-Be-Available-to-Medicare-Beneficiaries-at-Launch/default.aspx?fbclid=IwAR0cKhAv5C8TMZ8v8f98rlhnvBQ0JkFj3SLRyc7RdMeOAO3_Tpl95cKNX20 XX People who've had Covid-19 have a higher risk of developing diabetes, and that link seems to have persisted into the Omicron era, a new study finds. Mounting evidence suggests Covid-19 infections are tied to a new diagnosis of diabetes, though it's not clear whether this relationship is a coincidence or cause-and-effect. Big study here, 23,000 adults who'd had Covid-19 at least once. The raw data showed that people who'd had Covid-19 had higher risks of being diagnosed with diabetes, high cholesterol and high blood pressure after their infections. But when the researchers adjusted those numbers to account for the benchmark diagnosis, only the risk of diabetes remained significantly elevated. Covid-19 increased the odds of a new diabetes diagnosis by an average of about 58%. The new study is notable because it adds recent data, said Wander, who was not involved in the research. It also used strategies to try to address shifts in health care during the pandemic. Another strength of the study was that it included people who were diagnosed between March 2020 and June 2022, so it was able to estimate the risk even after the Omicron variant swept through the US. https://www.cnn.com/2023/02/14/health/covid-diabetes-risk-study/index.html XX Insulet making a couple of interesting acquisitions.. $25 million in assets from Automated Glucose Control LLC in California. And the same amount $25 million of assets from Bigfoot Biomedical. AGC and Insulet have had a partnership since 2016 which mostly involved the algorithm that led to Omnipod 5. Bigfoot has also claimed patents regarding more hands-off insulin delivery, The acquisition effectively doubles Insulet's IP portfolio, Eric Benjamin, the company's executive VP of innovation, strategy and digital products, said in a press release. XX Dr. Halis Akturk and colleagues began noticing patterns among people with T1D in Colorado hospital emergency departments (ED) after cannabis was legalized in the state. They have since conducted several nationwide retrospective studies on those living with T1D that also use cannabis, including hospitalization records and T1D Exchange Registry participant surveys. They found that T1D participants had repeated return visits to the ED in the following weeks, and DKA was frequently misdiagnosed. Based on that research, Dr. Akturk's team has recently developed a key to differentiating between DKA and a new syndrome that mimics DKA, one they've named HK-CHS: Hyperglycemic Ketosis-Cannabis Hyperemesis Syndrome. To treat HK-CHS, your care team will typically increase fluids, treat the high blood glucose with insulin, and balance your electrolytes, or anion gap. You will be advised to stop using cannabis until the symptoms resolve. These treatments will bring your blood glucose levels back into target range and get your gut moving again, which will ease the nausea and vomiting. Depending on your dose, frequency, and duration of use, symptoms may take several days to several weeks to resolve. https://t1dexchange.org/cannabis-t1d-risks/ XX About two thirds of people with type 1 diabetes in the United States have overweight or obesity, nearly the same proportion as Americans without diabetes, new nationwide survey data suggest. What's more, among people with overweight or obesity, those with type 1 diabetes are less likely to receive lifestyle recommendations from healthcare professionals than those with type 2 diabetes, and are less likely to actually engage in lifestyle weight management activities than others with overweight or obesity, with or without type 2 diabetes. "the lack of evidence for safe, effective methods of diet- and exercise-based weight control in people with type 1 diabetes may be keeping doctors from recommending such methods," these researchers say. "Large clinical trials have been done in type 2 diabetes patients to establish guidelines for diet- and exercise-based weight management, and we now need something similar for type 1 diabetes patients." https://www.medscape.com/viewarticle/988199 XX New research showing men and women have different risk factors when it comes to type 2 diabetes. In healthy women, low serum level of the adipose tissue protein adiponectin was an independent strong predictor of type 2 diabetes and prediabetes in the future. In healthy men, instead, low serum level of the liver protein IGFBP-1, was an independent strong predictor of type 2 diabetes and prediabetes This means that these proteins, which are measures of insulin sensitivity in adipose tissue (adiponectin) and liver and muscle (IGFBP-1), can predict whether one has a high risk of getting type 2 diabetes in 10 years. A previous study performed in Shanghai in 2016 showed gender differences in the same direction. In men with prediabetes the risk of future type 2 diabetes was significantly reduced if they increased their physical activity and muscle mass . In contrast, the same study showed that women with prediabetes must avoid increasing waist circumference and abdominal obesity or reducing large waist circumference to prevent type 2 diabetes. https://medicalxpress.com/news/2023-02-women-men-shown-factors-diabetes.html XX Tempramed/ VIVI Cap XX XX 2023 Diabetes Scholars applications are now open! If you're a high school senior living with type 1 diabetes in the US, you can apply to get money for college. https://diabetesscholars.org/apply-now/?fbclid=IwAR2txFmkmxp9qoMf5ZkKX0f83oxj3aOr69rCXeqozRDxq7Dt94e9QdBQrjg XX On the podcast next week.. Diatech Diabetes is a medical device company based out of Memphis, TN committed to changing the way infusion set failure detection is done with our infusion set failure detection system, SmartFusion. The last episode is with Dr Phyllisa Deroze all about explaining to your child when you, the parent, have diabetes. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon. ---- The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.

Pharm5
OTC Narcan, PBM Transparency Act, rocuronium shortage, & more!

Pharm5

Play Episode Listen Later Feb 17, 2023 4:05


This week on Pharm5: Narcan possibly OTC soon Dexcom G7 now available PBM Transparency Act hearing Rocuronium shortage Phase I Rankings now open Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Hoffman J. Narcan is safe to sell over the counter, advisers to the F.D.A. conclude. The New York Times. http://bit.ly/3S2btPf. Published February 15, 2023. Accessed February 16, 2023. Person, Bhanvi Satija PJ. U.S. FDA panel backs OTC opioid overdose drug, proposes label changes. Reuters. http://bit.ly/3xrx0r5. Published February 16, 2023. Accessed February 16, 2023. New Dexcom G7 CGM Nick Jonas Super bowl 2023. Dexcom. http://bit.ly/3Is32cU. Accessed February 16, 2023. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed February 16, 2022. Bringing transparency and accountability to Pharmacy Benefit Managers. U.S. Senate Committee on Commerce, Science, & Transportation. http://bit.ly/3YAhjKg. Published February 16, 2023. Accessed February 16, 2023. FDA drug shortages. FDA Drug Shortages. http://bit.ly/3Ir1kZb. Accessed February 16, 2023. Drug shortage detail: Rocuronium injection. ASHP. http://bit.ly/3Kat9q3. Accessed February 16, 2023. Schedule of dates. ASHP Match | Schedule. http://bit.ly/3I8MJA7. Published January 19, 2023. Accessed February 16, 2023.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Dexcom G7 Release Date, Omnipod Eros Discontinued, Best Age to Screen for T1D and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Feb 3, 2023 8:16


It's In the News, a look at the top stories and headlines from the diabetes community happening now. This week, Dexcom sets a US release date for the G7, we find out whether Tandem will be a Tidepool Loop partner now that Insulet and Medtronic are out, Omnipod Eros to be discontinued, a new study says there's a better age to test kids for type 1, a new smart insulin pen sensor can also be used to track dosing of GLP-1 medications, a new twist in the Faustman study of the TB vaccine to treat diabetes, the Sims 4 update brings CGMs to the game and more. Links and transcript below Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode Transcription:  Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by VIVI Cap – confidence on the go that keeps your insulin protected in hot or cold XX Learning a bit more about the Tidepool pump partnership, at least who it won't be. When Tidepool Loop approval was announced last month, it came without the original pump partners, Omnipod and Medtronic. CEO Howard Look said they do have a pump partner but that they're not ready to announced yet. I spoke to Tandem for next week's episode and they say its' not them. Quote “That's not part of our roadmap, it's not an integration we're working on.” XX Insulet announces it will discontinue the original Omnipod system. In a letter to healthcare professionals, the company says the system, referred to as Eros or Omnipod Classic will be discontinued at the end of this year. It's no longer available to new patients and existing customers will be transitioned to Dash or Omnipod 5. I'll link up the letter in the show notes. “Dear healthcare professionals, We have made the decision to discontinue the original omnipod insulin management system in the us after December 31 2023. This system is often referred to omnipod eros or omnipod classic. Insulet will continue to support the omnipod system throughout this year to allow existing patients ample time to transition to newer omnipod technology such as Omnipod dash or Omnipod 5. please note this product is no longer available for new patients in the US. After December 31, 2023 Insulet will not be able to guarantee the availability of the omnipod system supplies. “ https://www.facebook.com/photo/?fbid=10225188520677483&set=a.1253748061199 XX Civica continues to move ahead with more affordable insulin, announcing that Ypsomed will make and supply their pens. Civica plans to produce three insulin biosimilars priced at no more than $30 per vial and no more than $55 for a box of five pen cartridges. Contingent on FDA approval, Civica anticipates that its insulins will be available for purchase beginning as soon as 2024. XX New study shows screening kids at risk for type 1 diabetes only once – at age ten – is very effective in detecting the condition by the age of 18. These researchers also say “Almost no one” who is islet autoantibody negative at age 10 years despite a high familial risk for type 1 diabetes will develop clinical diabetes by the age of 18. Full study published in the Lancet. https://www.medwirenews.com/diabetes/age-10-years-optimal-type-1-diabetes-screening-point/23957596 https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00350-9/fulltext?fbclid=IwAR2kRNyGg6lnq3ZWsFkXnCvkeNiisg9mE2bbN_OnGiLrUpcHKXAaff3OkE4 XX The nonprofit public health advocacy group the Physicians Committee issued a formal complaint that a recent CBS "60 Minutes" segment was a promotion for Novo Nordisk's obesity drug, Wegovy, that was dressed up as a news segment. The Washington, D.C.-based group has filed a complaint with federal bodies alleging that the CBS "60 Minutes" segment that aired on New Year's Day breached the FDA's “fair balance” rules for drug ads. The Committee said in a release that the feature failed to talk about alternatives to the drug or about other weight-loss methods; that only experts “paid by Novo” were used in the program; and that the piece used overly promotional language. This has caused Wegovy supply issues for Novo which, coupled with manufacturing problems, only deepened bumps in production last year for the drug and led to an official shortage of the drug in 2022. A spokesperson for Novo Nordisk told Fierce Pharma Marketing: “Novo Nordisk did not provide any payment or sponsorship to CBS 60 Minutes for their reporting on obesity as part of a news segment that aired on January 1, 2023, and we did not control any of the content or have any role in identifying or selecting the doctors and patients featured in the news segment.” https://www.fiercepharma.com/marketing/health-group-lambasts-novo-nordisk-60-minutes-paid-news-program-weight-loss-med-wegovy XX Some researchers have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants. This is part of the Faustman study of the BCG vaccine. Some recent research suggests that the vaccine, first administered in 1921, also may protect against Covid-19 and respiratory diseases because of its broad effects on the immune system. The lead investigators of the pediatric trial are proceeding with the study, but N.Y.U. Langone's abrupt withdrawal could potentially jeopardize its viability if they are unable to collect data on the children at the N.Y.U. site. An earlier study by the scientists at Massachusetts General found that two doses of B.C.G. vaccine reduced blood sugar levels to near normal in a very small group of adults with Type 1 diabetes. Other studies of B.C.G., using different versions of the vaccine and following Type 1 diabetes subjects for varying periods of time, have yielded mixed results. The lead investigator of the trial, Dr. Denise Faustman, director of the immunobiology laboratory at Massachusetts General Hospital, said that N.Y.U.'s withdrawal was a serious deviation from trial protocol that may call into question the final results. https://www.nytimes.com/2023/01/20/health/diabetes-bcg-nyu.html XX A new smart insulin pen sensor can also be used to track dosing of GLP-1 medications. Brand names for GLP-1 medications include Trulicity and Ozempic. This device, called Mallya, attaches to the injector and connects it to a mobile app. It's already cleared in Europe and should be available in the US in the next few months. The device is compatible with most popular insulin pens, including Lilly's Kwikpen, Sanofi's Solostar, and the Novo Nordisk FlexPen. Biocorp also announced that it has partnered with Novo Nordisk, Sanofi, and Roche Diabetes Care to improve Mallya's current design moving forward. According to the Mallya website, the device's lifespan is two years before a replacement is needed, and in no way does it change the way that users operate their insulin pen. The device can be charged via USB and, with average use of three to four injections per day, requires charging once a month. Also, for those who have different pens for multiple types of insulin, the app can connect multiple Mallya devices, one for basal insulin and another for bolus, for instance. https://diatribe.org/fda-clears-smart-injector-pen-device-mallya XX Tempramed/ VIVI Cap XX New features popped up this week in the latest version of The Sims – after an update, players can opt for their characters to wear a CGM – Libre or Dexcom Freestyle Libre in the Sims 4 game. Search for CGM or Libre XX The Jonas Brothers officially have a star on the Hollywood Walk of Fame. On Monday, Nick, Joe and Kevin Jonas were honored during a ceremony on Hollywood Boulevard where their careers as musicians were celebrated. Their star was dedicated in the category of Recording and the trio was introduced by Monte and Avery Lipman of Republic Records, Ryan Tedder and writer and producer Jon Bellion. While the brothers still maintain their own separate projects -- Nick Jonas is set to produce and star in the upcoming film "Foreign Relations," Joe Jonas recently starred in the film "Devotion," and Kevin Jonas hosts the ABC series "Claim to Fame" -- they continue to make music together and are slated to release new songs this year. The group closed out Monday's ceremony by announcing big news about their upcoming new album, which will be released in May. They also said they'll be going on tour again. XX On the podcast next week.. Tandem Diabetes with an update on their road map announced last year. They've since acquired a patch pump company and one that makes infusion sets. A lot to catch up on! This past week's long format episode is with Tidepool Loop, a deep dive into what was approved with CEO Howard Look That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

DeviceTalks by MassDevice
Hear about Dexcom's evolving mission statement and Medtronic's Cranial and Spinal Technologies plans

DeviceTalks by MassDevice

Play Episode Listen Later Jan 20, 2023 75:17


In this week's episode, CEO Kevin Sayer takes a few minutes to share Dexcom's vision for the future OUTSIDE of diabetes. What does this mean for people with diabetes and others who could benefit from the powerful Dexcom G7? We also bring in a very popular interview from our MedtronicTalks podcast series – Skip Kiil, president of cranial and spinal technologies, shares some very wise career advice that helped him accelerate his career. He also talks with Tom Salemi about his move to Medtronic and how the company is ramping up to dominate the spinal and cranial spaces. His interview is sponsored by Allied Motion Technologies. Chris Newmarker, executive editor of life sciences at MassDevice shares his Newmarker's Newsmakers including Dexcom, Medtronic, Masimo, Philips, Abbott and Shockwave. Thanks for listening to the DeviceTalks Weekly Podcast. You can subscribe to the DeviceTalks Podcast Network on any major podcast player.

HomeKit Insider
Eve Matter Update, Dexcom G7 First-Look, Leviton Scene Controller Review

HomeKit Insider

Play Episode Listen Later Dec 19, 2022 45:32


Eve updates several devices to Matter, Airversa announces a HomeKit humidifier, Andrew gets a first look at the Dexcom G7 glucose monitor, and we review the Leviton Scene Controller and Lutron Diva smart dimmer.Send us your HomeKit questions and recommendations with the hashtag homekitinsider. Tweet and follow our hosts at @andrew_osu and @stephenrobles or email us here. Find us in your favorite podcast player by searching for "HomeKit Insider" and support the show by leaving a 5-Star rating and comment in Apple Podcasts.Sponsored by:Zocdoc: Go to zocdoc.com/hki and download the app to sign-up for FREE. Find doctors and specialists that take your insurance and even book appointments online!Kolide: Send your employees automated Slack messages with security and privacy recommendations! Get a FREE Kolide Gift Bundle after trial activation when you visit: kolide.com/homekitHomeKit Insider YouTube ChannelSubscribe to the HomeKit Insider YouTube Channel and watch our episodes every week! Click here to subscribe.Links from the showJustWatch - The Streaming GuideEve rolling out Matter firmware update for some HomeKit productsGetting started with Matter | evehome.comKasa Apple HomeKit Smart Dimmer Airversa to Launch Thread-Enabled HumidifierLevel Lock+ | LevelFirst look: New Dexcom G7 glucose monitorLeviton Scene Controller SwitchLutron Diva Smart DimmerLutron Claro Smart SwitchButton of the Month - The VergeSubscribe and listen to our AppleInsider Daily podcast for the latest Apple news Monday through Friday. You can find it on Apple Podcasts, Overcast, or anywhere you listen to podcasts.Those interested in sponsoring the show can reach out to us at: andrew@appleinsider.com

Juicebox Podcast: Type 1 Diabetes
#806 Dexcom G7 Approved By FDA (with Dexcom COO Jake Leach)

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Dec 10, 2022 39:35


Dexcom COO Jake Leach is here to talk about the FDA approval of the Dexcom G7. Get Gvoke Glucagon  CONTOUR NEXT ONE smart meter and CONTOUR DIABETES app Learn about the Dexcom CGM You may be eligible for a free 30 day supply of the Omnipod DASH  Get your supplies from US MEDwith the link or 888-721-1514 Learn about Touched By Type 1 Take the T1DExchange survey A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

In Touch with iOS
233 - Karaoke Music Sing With End to End Encryption - With Guest Chuck Joiner and Jeff Gamet

In Touch with iOS

Play Episode Listen Later Dec 10, 2022 76:19


The latest In Touch With iOS with Dave he is joined by guest Chuck Joiner and Jeff Gamet. Apple has added Music Sing karaoke. Our devices will have even more security with end to end encryption and you need to know the key. iOS 16.2 will be out next week with a 10 min limit on everyone setting in Airdrop. The App store has big pricing changes from  $0.29 to $10,000.There are 5 more things Apple still needs to release in 2023. Plus a guide to what phones have the fastest 5G in different countries.  The show notes are at InTouchwithiOS.com 
Direct Link to Audio  Links to our Show Click this link Buy me a Coffee to support the show we would really appreciate it. intouchwithios.com/coffee  Another way to support the show is to become a Patreon member patreon.com/intouchwithios Website: In Touch With iOS YouTube Channel In Touch with iOS Magazine on Flipboard Facebook Page Twitter Instagram News Apple Shares Most Popular Podcasts of 2022 Twitter Blue will be more expensive on iPhone to offset App Store fees Apple Announces App Store Changes, Including Expanded Pricing Up to $10,000 Biggest Apple News+ magazines may be having a tough time Tim Cook Confirms Apple Will Buy TSMC Chips Manufactured in Arizona Apple Music Adding a Karaoke Experience With Apple Music Sing   Press Release Apple introduces Apple Music Sing Then it's limited. Apple Music Sing Limited to Latest Apple TV, Not Coming to Older Models FDA approves iPhone connectible Dexcom G7 glucose monitor Apple Abandons Controversial Plans to Detect Known CSAM in iCloud Photos Topics Beta this week. Apple Seeds Release Candidate Versions of iOS 16.2 and iPadOS 16.2 iOS 16.2 for iPhone Expected to Launch Next Week With These 12 New Features Apple Seeds watchOS 9.2 Release Candidate to Developers Apple Seeds Release Candidate Version of tvOS 16.2 to Developers With Apple Music Sing Apple Expanding 10-Minute 'Everyone' AirDrop Limit to All Users With iOS 16.2 Apple Music Sing Now Available in iOS 16.2 Release Candidate End to end encryption on Apple devices! We review this latest addition to secure your data. Along with setting up a contact that can help unlock if you don't have the key. Apple Plans New Encryption System to Ward Off Hackers and Protect iCloud Data  Apple news release Apple advances user security with powerful new data protections Apple Announces End-to-End Encryption Option for iCloud Photos, Notes, Backups, and More  Apple Previews New iMessage and Apple ID Security Features Coming in 2023 Everything You Need to Know About Apple's New iCloud Encryption Feature Fastest 5G phones around the world. Details on the Fastest 5G Mobile Devices We explain what all these symbols are. What the cellular, Wi-Fi, and satellite symbols mean on your iPhone or iPad Apple Still Has These 5 Things to Release Heading Into 2023 Our Host Dave Ginsburg is an IT professional supporting Mac, iOS and Windows users and shares his wealth of knowledge of iPhone, iPad, Apple Watch, Apple TV and related technologies. Visit the YouTube channel https://youtube.com/intouchwithios follow him on Mastadon @daveg65,  Twitter @daveg65.and the show @intouchwithios Our Regular Contributor Jeff Gamet is a podcaster, technology blogger, artist, and author. Previously, he was The Mac Observer's managing editor, and Smile's TextExpander Evangelist. You can find him on Mastadon @jgamet as well as Twitter and Instagram as @jgamet  His YouTube channel https://youtube.com/jgamet About our Guest Chuck Joiner is the host of MacVoices and hosts video podcasts with influential members of the Apple community. Make sure to visit macvoices.com and subscribe to his podcast. You can follow him on Twitter @chuckjoiner and join his MacVoices Facebook group.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Dexcom G7 approved, Mark Cuban pharmacy looks at insulin pricing, T1D teens & blood pressure, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Dec 9, 2022 9:33


It's In the News.. a look at the top news stories in the diabetes community over the past seven days. This week, The US FDA gives the green light to Dexcom's G7 CGM, Mark Cuban's Cost Plus Pharmacy puts out a survey all about insulin, new studies looking at teens with type 1 and blood pressure as well as CGM and hospitalizations at the VA and much more! Previous episodes on Dexcom's G7: https://diabetes-connections.com/?s=g7 Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story is big news.. Dexcom's G7 gets FDA approval. This device with a shorter, half hour warm up time, with the sensor and transmitter all in one piece was approved for people age 2 and up with all types of diabetes. It was approved as an iCGM as expected, which is good news for the automated systems the G6 currently works with.. much more to come of course, we've done a lot of episodes on the features and design of the G7 so I'd urge you to listen to those if you haven't yet and of course we'll follow up with a new episode with Dexcom as soon as they'll talk to me! XX In other news.. Illinois Attorney General files a fraud lawsuit, accusing Eli Lilly, CVS Pharmacy, Novo Nordisk and several other pharmaceutical companies of artificially inflating the cost of insulin by over 1,000% since the late 1990s. The complaint singles out Eli Lilly in particular, noting the price for a dose of its analog insulin Humalog rose by 1,527% between 1997 and 2018. "Remarkably, nothing about these medications has changed," the complaint states. "Today's $350 insulin is the exact same drug defendants originally sold for $20." The suit also notes that 13% of Illinoisans, about 1.3 million people, live with diabetes, making the pharma companies' alleged monopoly scheme a public health threat. There are several other state and class action suits against the insulin makers going through the courts right now. So far none have landed more than a glancing blow. https://www.courthousenews.com/illinois-attorney-general-sues-over-sky-high-insulin-prices/ XX A new contender, though, might be entering the arena. Mark Cuban's Cost Plus Pharmacy put out a tweet this week asking for feedback on adding insulin to their lower-cost inventory. Quote - Insulin users: we are evaluating a future insulin test program and would like your feedback. If we offered a 90-day supply of a fast-acting insulin (up to 12 vials/8 packs of pens) for $170 incl. shipping, what would you think?” There's a feedback form and I'll link that up in the show notes. https://forms.office.com/Pages/ResponsePage.aspx?id=nlWlyavTPES7xglhq5HvDwx1m5bO2mRDq1ekDvUshMtUNUZBM0dDUTA3RVpUOEY1WVNWVDE4U0JTMiQlQCN0PWcu XX People with diabetes who used glucose lowering drugs prior to getting COVID-19 seem to have fewer COVID-19 related adverse outcomes during hospitalization. The mediations have already been shown, albeit in conflicting findings, to have possible benefits regarding morbidity and mortality among patients with diabetes who become infected with COVID-19. These meds include orals like Metformin as well as injectables like sglt2 inhibitors like Jardiance and Invokana GLP-1 agonists like Ozempic and Trulicity. https://www.ajmc.com/view/glucose-lowering-drugs-may-reduce-risk-of-covid-19-related-adverse-events-in-patients-with-diabetes XX New research about opioids and diabetes. This study says people People with diabetes who underwent surgery had a significantly increased rate of prolonged opioid use (POU) compared to people without diabetes who underwent surgery. 56% higher for people with type 2 and more than 200% higher for those with type 1. This was a big, retrospective, observational study of more than 43,000 people who had operations at a single diverse healthcare system in 2008-2019. The researchers say this shows that in a real-world setting healthcare providers are generally not accounting for individual risk factors when prescribing postoperative opioids. https://www.medscape.com/viewarticle/985068 XX Teens with Type 1 diabetes (T1D) who took bromocriptine, a medication used to treat Parkinson's disease and Type 2 diabetes, had lower blood pressure and less stiff arteries after one month of treatment compared to those who did not take the medicine, according to a small study published in Hypertension, an American Heart Association journal. People with type 1 are at higher risk of high blood pressure and those diagnosed with T1D as children have even higher risks for heart disease. Therefore, researchers are interested in ways to slow down the onset of vascular disease in children with T1D. The study's small size is a limitation. However, the researchers note that further research into bromocriptine's impact on vascular health in a greater number of people with Type 1 diabetes is warranted; they are planning larger trials. https://medicalxpress.com/news/2022-12-parkinson-medication-blood-pressure-teens.html XX CVS is facing a fraud charge with a lawsuit accusing them of deceptive fundraising in a campaign it held for the American Diabetes Association. Prior to each customer's transaction, a checkout screen prompts the customer with several options for pre-selected dollar amounts, as well as an opt-out option, allowing donations to the diabetes association. Yet, the plaintiff alleges, CVS did not forward donations to the diabetes association, but instead applied the donations toward a legally binding $10 million obligation CVS made to the diabetes association. In November, Edward L. Powers, a lawyer for CVS, filed a motion to dismiss the case, challenging the plaintiff and his lawyer on their interpretation of the alleged $10 million “debt.” CVS says they agreed to fundraise from customers and turn over the donations to the diabetes association. After more than three years of fundraising, CVS would make up the difference between the cumulative customer donations and $10 million, according to the motion. The group bringing the suit disagrees and says everyone who made a campaign donations” are entitled to damages. https://www.bostonglobe.com/2022/12/05/metro/tweet-draws-attention-lawsuit-accusing-cvs-fundraising-fraud-checkout-cvs-has-filed-motion-dismiss-suit/ XX Wearing a CGM can keep you out of the hospital.. according to a new study focusing on Veterans Affairs clinics in the US. Wearing a CGM was associated with a lower risk for all-cause hospitalization and mortality in adults with type 1 and type 2 diabetes. This was even though the people with type 2 who received CGM were actually unhealthier [than non-CGM users] according to the researchers, who called the mortality reductions, dramatic. During a presentation at the World Congress on Insulin Resistance, this researcher said: “All of this data suggests that we may need to look at these types of outcomes in a much more serious fashion, because there may be some additional benefits that we didn't appreciate. If true, then maybe CGM use may become more like the SGLT2 inhibitors, and we'll start using them in a much more comprehensive way.” https://www.healio.com/news/endocrinology/20221202/cgm-use-lowers-hospitalizations-may-reduce-mortality-in-type-1-and-type-2-diabetes XX Back to the news in a moment but first.. The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey XX outed by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications. Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it's authorized for so far. But that's left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. The class of drugs are GLP-1 receptor agonists, which mimic the effects of a hormone that can help people feel full. Within this group, Novo Nordisk's obesity drug Wegovy and diabetes drug Ozempic have been in short supply for months due to manufacturing issues and increased demand. Lilly's diabetes medication Trulicity has also been in tight supply, according to the drugmaker. That leaves tirzepatide, sold under the name Mounjaro. Lilly said in a statement that the drug is currently not in shortage, but that the company is continuing to monitor availability of competitor therapies and “supply with a focus on access for people with type 2 diabetes.” Related: Patients seeking novel weight loss drugs find a ‘wild west' of online prescribers In October, Lilly made changes to a discount program for the drug, now requiring people to attest they have type 2 diabetes. The coupons allowed patients to get the drug for $25 a month when it would otherwise cost about $1,000. Some pharmacies are also now checking if people have a diabetes diagnosis before filling prescriptions. https://www.statnews.com/2022/12/07/eli-lilly-tightens-access-tirzepatide-mounjaro-diabetes-obesity/ XX XX On the podcast next week.. yale lacrosse player Bri Carrasquillo was diagnosed just after her freshman year. Now she's part of Dexcom U – a new program for college athletes with type 1. Last week's show was One Drop is making a CGM? We'll talk to CEO Jeff Dachis about that. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Pharm5
COVID and monkeypox vaccines, PCAT retirement, and new FDA approvals!

Pharm5

Play Episode Listen Later Dec 9, 2022 4:11


This week on Pharm5: Bivalent booster for kids Jynneos protects against monkeypox Dexcom G7 approved for diabetes Rezlidhia (olutasidenib) approved for AML PCAT retirement in 2024 Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) covid-19 vaccines for children down to 6 months of age. U.S. Food and Drug Administration. https://bit.ly/3UIOuIP. Accessed December 8, 2022. Webinar November 29, 2022 - flu, RSV, COVID-19 and other respiratory threats this fall and Winter. Centers for Disease Control and Prevention. http://bit.ly/3Bf21AX. Published November 16, 2022. Accessed December 8, 2022. Reduced risk for Mpox after receipt of 1 or 2 doses of JYNNEOS vaccine compared with risk among unvaccinated persons - 43 U.S. jurisdictions, July 31–October 1, 2022. Centers for Disease Control and Prevention. https://bit.ly/3FzvTdL. Published December 8, 2022. Accessed December 8, 2022. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed December 8, 2022. Center for Drug Evaluation and Research. FDA approves Olutasidenib. U.S. Food and Drug Administration. https://bit.ly/3W2vSo5. Accessed December 8, 2022. Pharmcas Community. Retirement of the Pharmacy College Admission Test (PCAT). https://bit.ly/3Y9EomW. Published December 6, 2022. Accessed December 8, 2022.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Teplizumab approved, Twitter mess for Lilly, Medtronic 7-day infusion set launches, and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Nov 18, 2022 11:41


It's in the News.. the top diabetes stories of the past seven days. This week, the first drug to prevent T1D for any length of time is approved, Eli Lilly takes a financial hit from a Twitter impersonation stunt, Medtronic's 7-day pump infusion set is ready for consumers, Dexcom's G7 gets great reviews from older folks and educators for ease of use, a new study about light at night and diabetes and more! Learn more about the T1D Exchange: www.t1dexchange.com/stacey  Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX And by my new book “Still The World's Worst Diabetes Mom: More Real Life Stories of Parenting a Child With Type 1 Diabetes” available on Amazon in paperback and for kindle. XX Our top story  this week, the US U.S. Food and Drug Administration approves teplizumab, the first drug to delay the onset of type 1 diabets. We've been following this for a long time and I'll ink up our previous interviews with Provention Bio, the company that makes it. The brand name will be Tzield (teplizumab-mzwv) and it's an injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.   Tzield is administered by intravenous infusion once daily for 14 consecutive days. Lots of questions here and we'll follow up with an interview and more as soon as I can. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes https://diabetes-connections.com/delaying-a-t1d-diagnosis-the-fda-considers-teplizumab/ XX Our top story this week – the kerfuffle over on Twitter where a couple of accounts spoofed Ely Lilly. The insulin makers stock tanked 6% over just one day late last week, wiping billions of dollars from its market cap. On Nov.10, someone pretending to be Lilly's corporate account tweeted: “We are excited to announced insulin is free now.” You may know that Twitter under new owner Elon Musk was verifying any account with any name for just 8-dollars. Another verified but fake Lilly account tweeted profanities and taunted people who use insulin with higher pricing, again, also fake. Other major insulin makers Sanofi and Novo Nordisk were also caught up in the crossfire, with their stock prices dipping and questions over the high cost of insulin back in the headlines. In the understatement of the year, Lilly CEO David Ricks said – quote – “it probably highlights that we have more work to do to bring down the cost of insulin for more people” XX Mice with diabetes appeared cured after transplantation of insulin-secreting pancreatic islet cells, according to a Stanford Medicine study. The animals' immune systems were coaxed to accept the donated cells prior to transplantation through a three-pronged process that could be easily replicated in humans, the researchers said. No immune-suppressing treatments were necessary after the transplant to prevent rejection of the foreign islet cells. The technique, which builds on earlier work at Stanford Medicine, may open the door to a new type of organ transplant that doesn't require an immunologically matched donor or years on immune-suppressing medication. The difference here is that they do two transplants.. first doing a partial blood stem cell transplant which makes the new pancreas cells recognized as the body's own and less likely to be rejected. Long way to go here, but promising idea. https://med.stanford.edu/news/all-news/2022/11/islet-transplant-diabetes.html XX The first and only 7-day infusion set is ready to go.. after approval more than a year ago – in September of 2021, Medtronic says customers can now order the Medtronic Extended for the 600 and 700 series pumps. In clinical studies of the Medtronic Extended infusion set, study participants observed a decrease in the number of times an infusion set needed to be changed by 50% and the number of infusion set failures associated with high glucose levels was lowered.3,4 Study participants using the Medtronic Extended infusion set commented on the new infusion set being more comfortable to wear compared to their previous infusion sets and were happy with the longer wear feature in helping reduce the overall burden of insulin pump therapy.3,4 Additionally, use of the Medtronic Extended infusion set is estimated to result in annual costs savings of insulin of up to 25% due to a reduced number of infusion set and reservoir changes that result in unrecoverable insulin, as well as plastic waste reduction of up to 50%. https://www.prnewswire.com/news-releases/medtronic-launches-worlds-first-and-only-infusion-set-for-insulin-pumps-that-doubles-wear-time-up-to-7-days-in-us-301677790.html XX Recall for omnipod. This is an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. No serious injuries have been reported, but insulet has received reports tht the omnipod 5 controller chargting port or cable is discoloring or even melting due to excess heat. Customers are instructed to called insulet or login to an fda site. I'll link up all of that info in the show notes. at 1-800-6). Additional informati41-2049, which is available 24 hours a day, 7 days a week. Alternatively, Omnipod 5 users can utilize the FDA's MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htmExternal Link Disclaimer), by regular mail, or by fax (1-800-FDA-0178on, including instructions to customers to mitigate risk, can be found on the Company's website at www.omnipod.com/insulet-alertsExternal Link Disclaimer. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller XX Small study shows that using the Dexcom G7 is easier for older adults to insert and use. Results indicate that G7 CGM system required half as many steps to set up and deploy as the G6 system, with the system's system usability scale survey scores indicating excellent usability. The current study was launched to better understand ease of use and task burden of uptake of Dexcom's G7 CGM system. To do so, investigators designed their study as a formal task analysis with the intent of identifying the number and complexity of tasks associated with deployment of the G7 CGM system compared to the fifth- and sixth-generation systems in adults aged 65 years or older. A cohort of 10 older adults with no prior CGM experience and 10 CDCESs were recruited for inclusion in the investigators' formal task analysis. This analysis assessed ease of use among CDCESs through a survey after hands-on insertion and initiation of the system. For older adults in the study, ease of use was assessed using system usability scale (SUS) survey scores. In the post-test survey and SUS survey given to older adults, no responses lower than neutral were recorded and the SUS score for setup and insertion of the G7 system was 92.8, which investigators noted was reflective of an excellent usability rating. https://www.endocrinologynetwork.com/view/study-finds-dexcom-g7-set-up-is-easier-requires-fewer-tasks-for-older-adults-than-previous-generations XX Control IQ for people with type 2 works well and is safe. New study from Tandem Diabetes Care shows people with type 2 spent 3.6 hours a day long in target range after switching to the tslim x2 pump / Dexcom system from multiple daily injections or basal insulin only https://www.medtechdive.com/news/tandem-pump-dexcom-CGM-Type-2-diabetes/636448/ XX New program from Walgreens to help give more people access to information and diabetes services. Walgreens is teaming up with its Health Corners and third-party clinics to offer free A1C and blood glucose testing and diabetes education during November, Diabetes Awareness Month. For participating locations, visit Walgreens.com/FreeDiabetesScreening and I'll link that up. Walgreen is the largest provider of continuous glucose monitors including the Dexcom G6 and FreeStyle Libre 2 which track glucose levels all day and night – fewer finger sticks required. 7. Affordable care options and tools including Walgreens Prescription Savings Club and Find Rx Coverage which offer insulin savings programs and affordable, predictable copayments on select insulins. Walgreens Find Care provides access to in-person and virtual healthcare expertise from the comfort of one's home. XX Sleeping in a room exposed to outdoor artificial light at night may increase the risk of developing diabetes, according to a huge study of nearly 100,000 Chinese adults. People who lived in areas of China with high light pollution at night were about 28% more likely to develop diabetes than people who lived in the least polluted areas. We told you about a study published earlier this year that showed Sleeping for only one night with a dim light, such as a TV set with the sound off, raised the blood sugar and heart rate of the young people during the sleep lab experiment. These researchers caution that any direct link between diabetes and nighttime light pollution is still unclear, however, because living in an urban area is itself a known contributor to the development of diabetes https://www.cnn.com/2022/11/14/health/night-light-pollution-diabetes-sleep-wellness/index.html XX Researchers are recruiting 20,000 children for a trial to try to identify those at high risk of developing type 1 diabetes. If left undiagnosed or untreated, the condition can lead to life-threatening complications. The trial, led by the University of Birmingham, could mean access to new treatments for children at high risk. The researchers say it may also offer insights that could make screening for type 1 diabetes a possibility. ADVERTISEMENT Type 1 diabetes is an autoimmune condition where the immune system attacks and destroys cells in the pancreas which produce insulin. Insulin is crucial because it moves energy from food from the blood to the cells of the body - without it, the body cannot function properly. Approximately 29,000 children in the UK currently have type 1 diabetes, out of a total of about 400,000 people. For them, managing the condition involves injecting insulin and testing blood glucose levels regularly. The condition is very different to type 2 diabetes, which is often linked to poor diet or an unhealthy lifestyle. The organisers want children aged three to 13 to sign up for the trial, which will analyse their blood - through finger prick and vein tests - for autoantibodies. These are linked to the development of type 1 diabetes. Those with two or more autoantibodies have an 85% chance of having the condition within 15 years, and are almost certain to develop it in their lifetime. 'A simple test could have saved my son' Parth Narendran, professor of diabetes medicine, and Dr Lauren Quinn, clinical research fellow at the University of Birmingham, said there was a need to explore if screening children for type 1 diabetes in the UK would be possible in the UK. "Screening children can reduce their risk of DKA (diabetic ketoacidosis) at diagnosis around fivefold and can help them and their families settle into the type 1 diagnosis better," they said. DKA is a life-threatening complication of type 1 which can occur when diagnosis does not happen quickly. Rachel Connor, director of research partnerships at JDRF UK, which is co-funding the study, said new drugs that target the immune system were progressing through trials. "We are demonstrating that it is possible to delay the need for intensive insulin treatment in those most at risk. When these drugs become available in the UK, we need to be ready to use them straight away," she said. Dr Elizabeth Robertson, from Diabetes UK, which also funded the study, said: "Extra years without the condition means a childhood no longer lived on a knife-edge of blood sugar checks and insulin injections, free from the relentlessness and emotional burden of type 1 diabetes." https://www.bbc.com/news/health-63622084 XX New study on pancreas transplants. These researchers say Up to 90% of people who received a pancreas transplant enjoy freedom from insulin therapy and the need for close glucose monitoring. Biggest drawback is having to take immunosuppressants for the rest of their life. The number of pancreas transplants has declined in recent years. New paper this week in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. Another downside is that this isn't a long-term cure.. the paper says the median graft survival is around eight years and the transplanted pancreas does not always work well, so the patient might not be completely insulin-free. However, I do believe that the combined kidney/pancreas transplant should be considered for all patients with type 1 diabetes with an indication for a kidney transplant.” https://www.healthline.com/health-news/type-1-diabetes-the-benefits-and-limitations-of-a-pancreas-transplant XX Medtrnoic sending emails out regarding the CareLink™ Software outages. . For most of our customers, we were able to resolve the issue relatively quickly through an application fix that took effect when individuals logged out and then logged back into their CareLink™ accounts (reminder of these recommended actions available here). But we know this was not the experience for all, and for some of you the experience was extremely frustrating and lasted longer. Medtnoic is still working to resolve the issue for some customers. They stress this was not because of a security breach but don't give further details. https://app.medtronicdib.mdtpatient.com/e/es?s=357929245&e=822474&elqTrackId=b0ce7494b5bd47ad9b9c672c71086a1c&elq=3155b86a3ca045f0a2e27c182f392387&elqaid=7514&elqat=1&fbclid=IwAR1XYIdfEFpkUrdk-yTk6WKSvlsdncJBNrSy_OpdeuJhHXD2zi78WnxaSG8 XX Women with polycystic ovary syndrome (PCOS) were found to be at higher risk for developing type 2 diabetes over a 30-year period, according to new research presented at the 2022 American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo, and described in an article at Healio. PCOS is a hormonal disorder that causes enlarged ovaries containing small fluid-filled sacs, and it can have painful symptoms. Hormonal changes related to PCOS can also have effects throughout the body — including effects related to diabetes. One study estimated that nearly one in five adolescent girls with type 2 diabetes also has PCOS, although the nature of the link between PCOS and diabetes is still not fully understood. Many scientists believe, though, that insulin resistance — when tissues in the body become less sensitive to insulin, which is a large part of the disease process in type 2 diabetes — also plays a role in the development of PCOS. There is also evidence that correcting the hormonal imbalances seen in PCOS may reduce the risk of developing type 2 diabetes. A recent study showed that taking oral birth control pills as a treatment for PCOS reduced the risk for type 2 diabetes. https://www.diabetesselfmanagement.com/news-research/2022/11/16/polycystic-ovary-syndrome-linked-to-higher-risk-for-type-2-diabetes/ XX XX Back to the news in a moment but first.. The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey XX SAFE TRAVELS to all en route to San Francisco for the Fall 2022 #Diabetes Mine #Innovation Days. Can't wait to see u all in person! Nov 17 and 18 XX XX On the podcast next week.. My daughter Lea talks about siblings and type 1. Last week was all about Eversense E3 and the future of long-term CGM sensors. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Juicebox Podcast: Type 1 Diabetes
#782 Dexcom G7 User

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Nov 1, 2022 89:34


Emily's son has type 1 diabetes and he uses the Dexcom G7! InPen from Medtronic Diabetes Get Gvoke Glucagon  CONTOUR NEXT ONEsmart meter and CONTOUR DIABETES app Learn about the Dexcom CGM You may be eligible for a free 30 day supply of the Omnipod DASH  Get your supplies from US MED with the link or 888-721-1514 Learn about Touched By Type 1 Tak the T1DExchange survey A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives
Diabetes Dialogue: EASD 2022 and Recent CGM News

Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

Play Episode Listen Later Oct 13, 2022 34:08


In this special edition episode of Diabetes Dialogue, our hosts break down their top clinical takeaways from the European Association for the Study of Diabetes 2022 annual meeting, new data from the FLASH-UK trial, the global launch of Dexcom G7, and the announcement of US availability for the FreeStyle Libre 3.

Taking Control Of Your Diabetes - The Podcast!
#13: Diabetes and Technology

Taking Control Of Your Diabetes - The Podcast!

Play Episode Listen Later Oct 9, 2022 40:35


Drs. E and P are taking a trip down memory lane! They're discussing what living with diabetes was like before Continuous Glucose Monitoring (CGM) from inaccurate urine testing to finger sticks and rogue test strips everywhere. They discuss the evolution of CGM leading up to the most current devices and what makes each system unique, and how hybrid closed loop systems have completely changed the game. Learn why it's never too late to take control of your diabetes!  Questions We'll Cover in This Episode: What was it like living with diabetes before Continuous Glucose Monitoring (CGM)? What is the evolution of devices from Blood Glucose Monitors (BGM) to Continuous Glucose Monitors (CGM)? What was it like to get your first CGM? What are the different measurements you can get with CGM? What are the different options for CGMs? How will the Dexcom G7 improve from the Dexcom G6? How will the FreeStyle Libre 3 improve from the FreeStyle Libre 2? Is CGM necessary for people with type 2 diabetes? What are the different types of hybrid closed loop systems? Show notesLecture Dr. P meeting Dr. E for the first time: https://www.youtube.com/watch?v=g0FOfBrVjaM&t=3sLecture on Alerts and alarms: https://www.youtube.com/watch?v=3sp-15o-QcA&t=2sTCOYD Video Vault: https://tcoyd.org/tcoyd-video-vault/ ★ Support this podcast ★

Juicebox Podcast: Type 1 Diabetes
#768 Dexcom G7 Design

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Oct 7, 2022 41:24


Dexcom Senior Director of Global Product Design, Alex Diener has type 1 diabetes and he's here to talk about designing the Dexcom G7. Learn about the Dexcom CGM InPen from Medtronic Diabetes Get Gvoke Glucagon  CONTOUR NEXT ONEsmart meter and CONTOUR DIABETES app You may be eligible for a free 30 day supply of the Omnipod DASH  Get your supplies fromUS MEDwith the link or 888-721-1514 Learn about Touched By Type 1 Tak the T1DExchange survey A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... States explore insulin production, Dexcom G7 in wider release, weekly basal insulin and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Oct 7, 2022 7:10


It's “In the News…” a look at the top diabetes stories and headlines of the past seven days. This week: Michigan joins California in exploring producing and distributing insulin made in-state, new study looks at why girls have a harder time with T1D than boys, weekly basal insulin moves forward, Dexcom puts G7 in wider release (but not yet in the US) and more! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Michigan following California when it comes to exploring making and distributing insulin. Governor Gretchen Whitmer signed an executive directive this week to establish a Michigan-based insulin manufacturing facility, and facilitate the development, in conjunction with a partner or partners, of a low-cost insulin product for distribution in Michigan. Whitmer already announced a plan to cap insulin costs in her State of the State address in January. https://michiganadvance.com/blog/whitmer-signs-directive-seeking-to-lower-insulin-costs-wins-bipartisan-praise/ XX Novo Nordisk plans to move forward with its once a week insulin icodec. Recent studies show it worked as well or better than daily basal insulin, reducing A1C after 52 weeks. Novo Nordisk's ONWARDS program for once-weekly insulin icodec comprises six phase 3a global clinical trials, including a trial with RWE involving more than 4,000 adults with type 1 or type 2 diabetes. It is expected that Novo Nordisk will file for regulatory approval of the once-weekly insulin icodec in the first half of 2023 in the US, the EU, and in China. There is a separate and additional study for people with type 1 – looking at weekly insulin icodec wth mealtime insulin. That's expected to conclude in about six months. https://pharmaphorum.com/news/novo-nordisk-achieve-headline-results-with-icodec-insulin/ XX Big new study shows that girls tend to have more serious issues with type 1 diabetes than boys. This is physical, quantifiable stuff, including higher blood sugar levels, weight issues, and higher cholesterol. This was a review of 90 previous studies at Amsterdam University Medical Centers. that women and girls have typically not received as much attention as study subjects as men. These researchers say more study is needed including finding ways to help doctors treat girls with type I diabetes differently than boys https://www.healthline.com/health-news/why-type-1-diabetes-can-be-tougher-on-girls-than-boys XX Alarming new study says that cases of type 1 worldwide could double by 2040. Tracking has improved in recent years, but Type 1 diabetes is underrepresented. In addition, because many countries don't collect Type 1 diabetes data, the numbers have historically skewed toward North America and Europe. About 175,000 people worldwide died because of Type 1 diabetes in 2021, they believe, and 63 to 70 percent of the deaths in those under age 25 occurred because the disease wasn't diagnosed. This study is in the Lancet Diabetes and Endocrinology https://www.washingtonpost.com/health/2022/10/03/diabetes-type-one-surge/ XX Big new study looking at which drugs paired with Metformin work the best for type 2. The trial was conducted at 36 study centers nationwide with more than 5000 people. Three groups took metformin plus a medicine that increased insulin levels: sitagliptin or Januvia, liraglutide or Victoza, or glimepiride or Amaryl. The fourth group took metformin and a long acting insulin. After about five years of follow-up, the researchers found that all four drugs improved blood glucose levels when added to metformin. But those taking metformin plus liraglutide or the long-acting insulin achieved and maintained their target blood levels for the longest time. The effects of treatment did not differ with age, sex, race, or ethnicity. However, none of the combinations overwhelmingly outperformed the others. https://www.nih.gov/news-events/nih-research-matters/popular-diabetes-drugs-compared-large-trial XX Dexcom's G7 is getting a wider rollout: the United Kingdom, Ireland, Germany, Austria and Hong Kong, with launches in New Zealand and South Africa in the coming weeks. I'll link up the promotional video.. no news yet from the US FDA on when the G7 will be approved in the US. I am talking to Dexcom's Senior Director of Global Product Design for Tuesday's podcast episode. https://www.youtube.com/watch?v=dYqNUf0paAU XX Tandem's t:connect mobile app is now compatible with the latest iOS operating system on version 2.3 of the t:connect mobile app. Until this update, you could lose the mobile bolus if you updated your phone. Tandem also added a new iPhone and nine new android devices to their compatibility list. We'll link that up in the show notes. : https://www.tandemdiabetes.com/.../device-compatibility XX Back to the news in a moment but first.. The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey XX The College Diabetes Network announces a name change – they'll now be known as the Diabetes Link. The groups says this new name reflects a commitment to expand support to the larger young adult diabetes community, whatever the type of diabetes they live with and whether they're in school or in the workforce. Currently, there are 3 million young adults (ages 17-30) living with diabetes in the U.S. and that number continues to increase every day. The Diabetes Link is the only national organization that focuses specifically on people in their teens and twenties, in recognition that this time of their lives is full of enough change and challenges without a chronic disease added to the mix. XX And finally, another zoo animal with a CGM. Tiana is a lemur in New Zeleand. The zoo's education officer, has diabetes and recommended the Dexcom for the lemur. Interestingly, they aren't using insulin here, but rather a hypoglycemia medication and are altering the lemur's diet. Apparently lemurs are prone to something more like type 2 diabetes due to some iron issues or if they eat too much sugar, but Tiana's case more resembles type 1. https://www.stuff.co.nz/national/130016440/meet-tiana-the-diabetic-lemur-with-a-glucose-monitor-stuck-to-her-back#:~:text=Hamilton%20Zoo%20resident%20lemur%2C%20Tiana,with%20diabetes%20in%20the%20zoo.&text=Zoo%20vet%20Tori%20Turner%20says,Hamilton%20has%20joined%20the%20club. XX On the podcast next week.. Dexcom's Senior Director of Global Product Design – Very We'll talk about what goes into designing a comletley new product like the G7. He lives with type 1 himself. This past episode is all about how diabetes communities around the world stayed connected during the early days of the pandemic, Listen wherever you get your podcasts Hey for you parents, we've got a webinar on Halloween, link in the show notes and on my social media. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Islet cell implant update, BG check with radio waves, preschool T1D detection & more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Sep 9, 2022 6:45


It's in the news! The top stories and headlines around the diabetes community this week include: A new way to sneak islet cells into the body without needing immunosuppressive drugs, routinely checking young children for T1D markets before symptoms show up, a non invasive way to measure blood glucose uses Radio Frequency, a DIY movement publishes in the New England Journal of Medicine and more! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX French biopharma company Adocia has established a first proof of concept for its AdoShell Islets implant. This was in rats.. but they achieved glycemic control without insulin injections and without immunosuppressive drugs for four months. AdoShell Islets is an immuno-protective synthetic biomaterial that secrets insulin in response to blood glucose levels. The physical barrier formed by the AdoShell biomaterial allows the implanted cells to be invisible to the host's immune system while allowing the necessary physiological exchanges to occur for the survival and function of the islets. These researchers are optimistic that their unique approach can be translated from one species to another. https://www.labiotech.eu/trends-news/adocia-implants-diabetes/ XX Can starting a closed loop system right away help keep kids with type 1 in the honeymoon stage longer? New study says.. probably not. The latest findings are from the Closed Loop From Onset in Type 1 Diabetes (CLOuD) trial, a multicenter, open-label, parallel-group, randomized study, published online September 7 in the New England Journal of Medicine by Charlotte K. Boughton, PhD, and colleagues. In CLOuD, 97 youths aged 10-17 years were randomized to hybrid closed-loop therapy or standard insulin therapy (control) within 21 days of type 1 diabetes diagnosis. I found this a bit confusing, in the standard insulin therapy groups, participants could switch to insulin pump therapy or use flash or continuous glucose monitoring (CGM) or approved closed-loop systems if clinically indicated. So this isn't comparing an AID system to MDI. At 12 months, there were no differences after a mixed-meal tolerance test, with levels declining in both groups and dropping further by 24 months. Interestingly, they said glycemic control didn't differ significantly between the two groups. https://www.medscape.com/viewarticle/980356 XX Moving closer to a non-invasive way to measure blood glucose. The GlucoRx BioXensor uses radio frequency technology alongside a multiple sensor approach to measure blood glucose levels every minute. This looks to be about the size of a Libre 3 or Dexcom G7.. It's said to have smart alarms and remote monitoring capability and just sticks on the skin. The MARD is 10 point 4, which is less accurate than CGMs on the market now, but much better than any other noninvasive device to make it this far. In addition to measuring blood glucose the makers say it can measure oxygen levels, ECG, respiration rate, heart rate, temperature, activity, sleep, and early fall detection. Pivotal clinical study later this year and then the say they'll submit for European approval. https://www.med-technews.com/news/latest-medtech-news/glucorx-and-cardiff-university-to-bring-out-non-invasive-con/ XX RESEARCHERS in Oxford have launched the first UK study in the general population to test for early markers of type 1 diabetes, before children develop symptoms or need insulin. They're offering a finger stick test when children have their pre-school vaccination. Very small start, only 60 kids, but these researchers say with a recent, more accurate test to check for markers early on, they hope to find more children before DKA sets in. https://www.oxfordmail.co.uk/news/20977659.oxford-scientists-launch-study-early-markers-type-1-diabetes-children/ XX The first Randomized Controlled Trial on open source automated insulin delivery (AID) is now published in a peer-reviewed medical journal. Big news for and from the we are not waiting crowd. The CREATE Trial evaluated the efficacy and safety of an open-source system using the OpenAPS algorithm in a modified version of AndroidAPS. This study included children and adults and found that across all ages, time in range was 14 percent higher than those who used commercial hybrid closed loop systems. There's more to it, and I”ll link it up, but this study concluded that a widely used open-source AID solution, works and is safe. Congrats to Dana Lewis and all the researchers involved. https://diyps.org/2022/09/07/nejm-publishes-rct-on-open-source-automated-insulin-delivery-openaps-algorithm-in-androidaps-in-the-create-trial/ XX Back to the news in a moment but first.. The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey XX Medtronic is waiting for FDA clearing of the new 780G.. already approved in Europe. New study results published in The Lancet Diabetes & Endocrinology, Medtronic announced Thursday put the AID pump up against multiple daily injections plus CGM. Small study, 82 people, all with an A1C over 8. After using the 780G for six months, the group saw a reduction of 1.4 percent in their levels with a quarter of that group dropping their A1C below 7. None of the MDI group dropped to that level. Time in range saw most improvement overnight. The MiniMed 780G system has been cleared in Europe since 2020. Medtronic submitted it to the FDA for U.S. approval in the spring of 2021 but is still awaiting a decision, slowed down by the roadblocks caused by a late 2021 warning letter from the agency that called out quality control issues at the California headquarters of its diabetes business. https://www.fiercebiotech.com/medtech/medtronics-new-minimed-insulin-pump-adds-27-boost-time-range-study-finds XX Change at one of the top posts at Dexcom. Jake Leach moves from Chief Technology Officer to Chief operating officer. He's been at the company since 2004 to work on the first commercial Dexcom CGM system. He's been a frequent guest of the show and we hope that continues. https://www.businesswire.com/news/home/20220831005236/en/DexCom-Promotes-Jake-Leach-to-Chief-Operating-Officer XX Next week we're looking ahead to the New York City Marthong. Beyond Type 1 puts together a gret team each year and I'm taking to one of the runners. He's also nabbed a spot in the world series of poker – which do you think is tougher on his type 1 diabetes? This past episode is all about Omnipod 5 – a panel of people who've sued it for a few weeks now.. and the director of medical affairs to answer your questions. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Juicebox Podcast: Type 1 Diabetes
#710 Joanne Milo Wants Her Data

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Jun 30, 2022 36:49


Comment submissions are closed next Thursday (July 7th) so DO NOT WAIT to show your support. Instructions: Tap on link: tinyurl.com/ct6n22ft Fill in the comment box with your message Select Option: Device Industry C0012 Enter your email Tell about yourself: choose either Individual or Anonymous Check the box that you have read/understood Tap the GREEN Submit button THAT'S IT! All in under 2 minutes! Do you like continuous access to your CGM BG data so that your DIY Loop WORKS?! Do you know that we might lose that access with Dexcom G7 and Abbott Libre3 has never allowed access?   I NEED YOU TO ACT ... IT MATTERS! Please join me in a letter-writing campaign to fill their inbox with our comments and concerns! NOW!   Suggested text: "I live with insulin-requiring diabetes, an incurable chronic disease requiring continuous monitoring of blood glucose values and administration of insulin. It is imperative that access to my own devices remains possible. The ability to receive glucose values from my continuous glucose monitor and the ability to command my insulin pump to deliver insulin are already permitted and expected of me. In fact, if I don't do these, I will die. So please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my own devices."   When you put your name (or even if you post anonymously) consider including ‘pwd' or ‘t1d' or however you identify yourself as someone with diabetes, I.e. ‘Sally Smith, T1D' so that they know our community has a voice   You can see the comments that have already been submitted and approved: https://www.regulations.gov/docket/FDA-2021-D-1158/comments

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Dexcom to acquire Omnipod? People with T1D living longer, JDRF awareness on Everest and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later May 27, 2022 5:37


It's in the news! Got a few minutes? Get caught up! Top stories this week: Dexcom is reportedly in talks to buy Omnipod, Abbott & Dexcom sue and countersue each other over patents, new study showing people with type 1 diabetes are living longer, a JDRF advocate climbs Mt Everest, and more! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story this week is still developing.. but Bloomberg reports that Dexcom is in talks to acquire Insulet, the makers of Omnipod. Neither company has commented publicly on the report. Bloombeg says, “Talks between the companies are ongoing and an agreement could be reached in the coming weeks, said the people, who asked not to be identified because the information is private. Discussions could still be delayed or fall apart, the people said.” Insulet's stock has gone up and Dexcom's has gone down. These companies already have an agreement in which the Omnipod and Dexcom CGMs communicate.. Dexcom also has an agreement with Tandem and some other companies – those aren't expected to change in the short term, but there are a lot more questions than answers about this report. I'm scheduled to talk to Dexcom's CEO in early June and we'll continue to follow this story. https://www.bloomberg.com/news/articles/2022-05-23/dexcom-is-said-in-talks-to-acquire-device-firm-insulet XX Meanwhile, Dexcom and Abbott are currently going head-to-head over twelve separate patents covering their respective CGMs. Both companies are launching newer products soon, with the Dexcom G7 and Freestyle Libre 3 already available in Germany. Dexcom first sued in 2021.. Abbot then countersued. A UK High Court will hold three separate technical trials, planned for December 2022, April 2023 and July 2023. https://www.juve-patent.com/news-and-stories/cases/dexcom-and-abbotts-fight-over-glucose-monitoring-patents-intensifies-in-europe/ XX People with type 1 diabetes are living longer according to a new study based on data from Australia, Denmark, Latvia, Scotland, Spain, and the United States. The years analyzed varied by country, but overall, they cover 2000 to 2016 and include 1.5 million person-years. The data show that country-by-country annual changes in age- and sex-standardized all-cause mortality among people with T1D dropped by between 2% and nearly 6% over the study period. The risk of dying was still higher than in people without type 1, mostly because of diabetes complications. https://www.ajmc.com/view/all-cause-mortality-falling-among-people-with-type-1-diabetes XX A new study finds that herpes virus may contribute increased risk of type 2 diabetes. Herpes viruses are one of the most common viruses in humans, with 8 types currently known. Any of these can cause lifelong latent infections after an initial, usually mild or asymptomatic primary infection. Until recently, viruses had only been proposed as a potential trigger for the development of type 1 diabetes. This study was based on health data from nearly 2000 people, men and women, in Germany. The researchers found that herpes viruses consistently and complementarily contributed to the development of prediabetes and diabetes, even after accounting for sex, age, BMI, education, smoking, physical activity, parental diabetes, hypertension, lipid levels, insulin resistance, and fasting glucose. https://www.pharmacytimes.com/view/study-herpesvirus-infection-may-increase-risk-of-diabetes XX This one sounds kind of odd, but a one-time diabetes treatment may lower average blood sugar and improve long-term insulin resistance and pancreatic function. The company is Fractyl, the treamtment is an outpatient proceure that applies heat to the intestinal walls to – quote – strip out and reset the mucosal lining, which can thicken over years from dietary fats, sugars and other foods. Fractyl believes this thickening contributes to the insulin resistance seen in Type 2 diabetes. The device has breakthrough FDA designation, but no approval yet. It is approved in Europe. https://www.fiercebiotech.com/medtech/fractyl-shows-its-intestine-resurfacing-device-type-2-diabetes-improves-insulin-resistance XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX XX Cameron Kenny just climbed Mt Everest and unfurled the JDRF flag at the summit. Kenny doesn't live with diabetes, but his brother does. Kenny is an accomplished climber and raised money for JDRF during his prep and climb of Everest. I can't seem to find his brother's name anywhere, even in the JDRF posts, so if you know this family, please let me know. XX On this week's long format episode, you'll hear about Mike Joyce is set to complete an incredible long-distance hiking trail. It's actually three trails – the longest in the US – he'll talk about how he does this with type 1. Next week, type one way ticket travel – a new way to get teenagers with T1D to experience international adventure travel. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Diabetes Connections with Stacey Simms Type 1 Diabetes
Dexcom G7 Update With CTO Jake Leach

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later May 10, 2022 42:42


Dexcom's G7 is in front of the FDA right now. There are some significant changes to the system, including what's basically a snooze for essential alarms, including the urgent low. Dexcom's Chief Technology Officer Jake Leach answers your questions about adhesive, direct to watch, accuracy, and even mentions the G8. Here's more information about the European approval (includes a video of the system) This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about AFREZZA* *Click here to learn more about OMNIPOD* *Click here to learn more about DEXCOM*

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. FDA suspends stem cell study, Omnipod 5 wider rollout, Dexcom G7 update and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later May 6, 2022 6:40


It's "In the News..." Got a few minutes? Get caught up! Top stories this week: An FDA hiccup for Vertex, Omnipod 5 starts wider rollout, New peek at Dexcom G7 features, Beta Bionic study info, "Hey Alexa, predict my blood sugar" and Healthline shuts down their main source of diabetes news and information. -- Join us LIVE every Wednesday at 4:30pm ET Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about AFREZZA* *Click here to learn more about OMNIPOD* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story – bit of a surprise for Vertex – the FDA puts a clinical hold on their newest trial. This is the company that made big headlines last fall – that New York Times article likely sent to you by everyone you know about a stem cell cure for type 1. That's when Vertex reported data on the cell therapy from a single patient who achieved a “robust” restoration of islet cell function after receiving a drug called VX-880. That response is going strong they say at day 270. This week, Vertex showcased results from another patient and said a third patient has received the full dose. A company spokesman says they're surprised by the clinical hold given the evidence so far and there have been no serious adverse events. They say they'll work with the FDA to get the trial moving again as soon as possible. https://www.fiercebiotech.com/biotech/unwelcome-surprise-vertex-fda-slaps-hold-phase-12-diabetes-cell-therapy-study XX Insulet announces that Omnipod 5 has completed the Limited Market Release and will be rolling out to a wider audience soon. Those who signed up for what they call the interest list will be notified first – we're told watch for that email this week. If you haven't signed up, sit tight. Omnipod 5 still isn't yet available through all insurers and at every pharmacy, but the roll out will continue slowly through the year. https://www.omnipod.com/current-podders/resources/omnipod-5/faqs?fbclid=IwAR1fghbXl4uP4H3z8DGovriAocpZyDyPzLdPzME_taonv3_ZfPC3XqukHJY XX We're learning more about Dexcom's G7 – approved in Europe and in front of the US FDA right now. Sensors will have a bit of a grace period – they'll keep working 12 hours after the 10 days are up. You'll also be able to silence the urgent low and sensor fail alarms for six hours – that's new. I'm talking to CTO Jake Leach for next week's long-format show and he's got a lot of info to share. I asked as many of your questions as I could, so please come back for that one. XX New study results about the iLet, the insulin only bionic pancreas from Beta Bionics. This is one of the many studies presented at A-T-T-D.. People in the study saw about half a point come off their A1Cs after 13 weeks and there was no increase in hypoglycemia. They also saw more than 2 and a half hours more time in range. The iLet is unique in that you only enter your weight and tell the pump system when you're eating – there are no basal rates or a need to enter carbs. No timeline for release but the company says its regulatory submission is currently under FDA review. https://www.globenewswire.com/news-release/2022/04/30/2433019/0/en/The-iLet-Bionic-Pancreas-Significantly-Reduced-HbA1c-and-Improved-Time-in-Range-vs-Standard-of-Care-for-a-Diverse-Range-of-People-with-Type-1-Diabetes.html XX Amazon.com's online pharmacy PillPack has agreed to pay almost 6-million dollars to resolve claims that it overcharged government health insurance programs by dispensing more insulin injector pens than patients needed. That's the headline, but -editorial here – this story just shows a lot about what's wrong with our system. Many of us have had this happen – used to be if you had a prescription for insulin pens, they'd just give you the box of 5 – even if the prescription was written for 3 or 4. Now, they have to break open the box and count out the exact amount. It's not as though a patient was over-charged.. and that's not the focus of this lawsuit. This was about government health insurance programs. I get it, we're all paying for that in our taxes, but there's got to be a better way. Maybe pass that co-pay cap, or let Medicare negotiate prices or just cap the price overall. Then this issue – and many others – goes away. https://www.reuters.com/legal/litigation/amazon-unit-pay-58-mln-insulin-overbilling-2022-05-02/ XX Walmart Health's telehealth company MeMD launched a virtual care diabetes program this past week. The initiative, known as the Walmart Health Virtual Care Diabetes Program, was developed for employers and payers as a standalone offering or as part of a comprehensive telehealth program. It's a partnership with the ADA and includes a consultation with a licensed medical provider to discuss patient history, eating habits and more. https://www.healthcareitnews.com/news/walmart-launches-telehealth-program-aimed-diabetes XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX An Australian company joins the diabetes conversation on your Alexa device. Jade Diabetes says their My Jade skill can centralize logging, dose calculation and dose management. It can also suggest dose changes within 3 hours. They say “Jade is the only system to use accurate predictions to alert patients of future risks at a given time.” It uses info from CGMs, connected glucose meters, digital pens and data from Apple Health. https://www.businesswire.com/news/home/20220504005004/en/Jade-Diabetes-makes-Diabetes-Simpler-with-Alexa-Insulin-Dosing XX Really sad to hear that Healthline has decided to close down what I think has been just one of the best sources of Diabetes news & info.. Diabetesmine. It was started by Amy Tenderich after her diagnosis in 2003 and acquired by Healthline in 2013. I've had her and Managing Editor Mike Hoskins on the show many times. Amy's amazing other project – D-Data Exchange will live on. These are the bi-annual #DData forums connect experts, advocates and innovators developing data platforms, apps, algorithms and next-gen devices to take full advantage of data-driven diabetes care. You may recall the term We Are Not Waiting was coined at the first D-Data exchange – it's a cool place to be! The next one is coming up June 2nd, more info in the show notes. https://summer2022-ddata.eventbrite.com XX On this week's long format episode, you'll hear about the Mental Health Plus diabetes conference.. the organizers said every conference has one session on mental health – we really need more. So they did it. Love that! Next week, as I mentioned, Dexcom's Chief Technical Officer on the G7, some interesting new info.. and I asked him all of your questions. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

Juicebox Podcast: Type 1 Diabetes
#676 Dexcom G7 is Getting Close

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later May 5, 2022 36:35


Jake Leach Executive Vice President and Chief Technology Officer at Dexcom is back to talk G7. Show notes for people who are Bold with Insulin Get your supplies from US MED with the link or 888-721-1514 Learn about the Dexcom CGM You may be eligible for a free 30 day supply of the Omnipod DASH  Get Gvoke Glucagon  Learn about Touched By Type 1 CONTOUR NEXT ONE smart meter and CONTOUR DIABETES app Tak the T1DExchange survey A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadioRadio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... ATTD News From Dexcom, Beta Bionics, Libre, Ypsomed & more

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Apr 29, 2022 6:29


It's “In the News…” Got a few minutes? Get caught up! Our top stories this week include headlines from the ATTD Conference - that's the Advanced Technologies and Treatments for Diabetes Conference. There's a bit of new information about the Dexcom G7, Beta Bionics announces it will release pivotal trial results, and news of the first AID system using the Libre 3 is announced. Along with ATTD there's news about type 2 diabetes and grocery stores, all types of diabetes and nursing homes and a person with T1D is on the cover of British Vogue. Learn more about T1D Exchange here  Join us LIVE every Wednesday at 4:30pm ET Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about AFREZZA* *Click here to learn more about OMNIPOD* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX This week ATTD begins – that's the Advanced Technologies and Treatments for Diabetes Conference, so you can expect to hear a lot of news. I'll include some here, some next week and we've got future interviews lined up with a lot of the companies making headlines.. XX First up, a peek at more features in Dexcom's G7 system. It's approved in Europe but not the US and features what they're calling more meaningful alarms. You can silence more alarms, including urgent low & sensor fail for up to six hours, there's also a new 12 hour grace period at the end of the 10-day sensor life. It's already been announced the G7 has a much shorter warm up period, only half an hour, and is much smaller. -- Also at ATTD, Beta Bionics will be releasing Pivotal Trial Results of the iLet Bionic Pancreas. The iLet is a pump – connected to a CGM that is designed to autonomously determine and deliver insulin doses to control blood glucose levels. You'll recall this pump was originally designed to deliver both insulin and glucagon.. but the current iteration is insulin only. They says this pivotal trial population was more diverse and representative of the United States type 1 diabetes community than any previous pivotal trial of an automated insulin delivery system. We'll have more info on what these trials actually said next week. https://www.globenewswire.com/news-release/2022/04/25/2427846/0/en/Pivotal-Trial-Results-of-the-iLet-Bionic-Pancreas-To-Be-Presented-at-ATTD.html XX The first automated insulin delivery system using the FreeStyle Libre has been announced. This is in Europe and it's the Libre 3, Ypsomed pump and CamDiab software system. Expected by the end of the year, this is described as a self-learning app, a hybrid, closed-loop system that runs on an Android smartphone and can be tuned to users as young as one year old https://www.fiercebiotech.com/medtech/abbott-launches-diabetes-team-ypsomed-camdiab-bring-artificial-pancreas-system-europe XX And a new consensus meeting on Time in Range. In 2019, diaTribe formed the Time in Range Coalition, whose goal was to ensure that Time in Range (TIR) becomes the primary glucose metric for daily management, complemented by A1C, in diabetes care globally. But there isn't an internationally consensus on the use of CGMs in clinical trials. This meeting will help standardize those methods. XX Other highly anticipated – or at least well-publicized- studies coming to ATTD include those from Tandem and Omnipod and almost every big diabetes tech company. Lots more to come next week and we already have interviews set with Dexcom and Beta Bionics to we'll talk about all this in the long format episodes in weeks to come. XX Overtreating type 2 diabetes is apparently very common in nursing homes.. which can be a big problem as people get older and may require changes. New study in the Journal of the American Geriatric Society show about 40% of nursing home residents with type 2 diabetes may be overtreated. These researchers say one big issue is that at admission, residents are given a very big medical work up, but that isn't followed up on year to year. Often as people age, its recommended their A1C is maintained a bit higher, for safety reasons, so a target A1C could easily change years or even months after someone moves into assisted care or a nursing home. https://www.healio.com/news/endocrinology/20220422/diabetes-overtreatment-common-in-nursing-homes-with-little-medication-deintensification XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX New survey looking at how people with diabetes rate their grocery stores. From D-Q&A this was a big survey, more than 5-thousand people statistically representative of all people with diabetes in the United States. They found more than half of people with diabetes did not feel very supported in maintaining their preferred eating habits at home. 28% of low-income people with diabetes find it somewhat or very challenging to find their preferred foods when grocery shopping. Stores rated best? Aldi, Publix, Costco, H-E-B, and Hyvee. The worst rated were BJ's, Vons, Shaw's, Ralphs, Tops & Randalls https://d-qa.com/major-grocery-chains-failing-to-meet-the-needs-of-people-with-diabetes/ XX Last year she made big news by walking the runway with her Omnipod visible, this year Lila Moss is – we think – the first person with type 1 on the cover of Vogue magazine. She did an interview with them that's on YouTube – I'll link up the video. She says she has an Apple air tag attached to her Pod PDM. Going through her handbag essentials, she included glucose tabs and talked about how her diabetes is something she doesn't keep hidden but just isn't always visible. Just nice to see a matter of fact interview featuring type 1. https://www.youtube.com/watch?v=5piEaumF6f0 XX On this week's long format episode, you'll hear from Civica RX – this is the company pledging to put out insulin without making a profit. We'll hear why they think this will work and how soon it'll be available for purchase. Next week we're talking about a new mental health conference for people with diabetes – it's virtual so you can participate from anywhere. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Dexcom G7 approved in Europe, people with diabetes living longer, non-profit insulin and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Mar 18, 2022 5:52


It's “In the News…” Got a few minutes? Get caught up! Top stories this week: Dexcom G7 approved in Europe, JDRF speaks out on non-profit insulin plan, Ukraine diabetes aid progress, texting for T2D, Reaction to Pixar's Turning Red -- Join us LIVE every Wednesday at 4:30pm ET Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX The news is brought to you by The World's Worst Diabetes Mom: Real Life Stories of Parenting a Child With Type 1 Diabetes. Winner of best new non-fiction at the American Book Fest and named a Book Authority best parenting book. Available in paperback, eBook or audio book at amazon. XX Our top story this week.. Dexcom gets the CE Mark for it's new G7 system, which means it's approved in Europe. The approval is for people ages 2 and up, including pregnant women. I'm putting the full screen photo up here and I'll post this on the website and in the FB group for those listening.. interesting to finally get a good look at the much smaller applicator – as expected looks a lot like the Libre. Also interesting, all the PR for this has said, developed in partnership with Verily.. remember them? That was part of google, probably best known for saying they were going to develop a contact lens that would monitor glucose. I've reached out to Verily, love to know more about this partnership. Anyway, we've done a ton on G7, I'll link up some of our recent conversations with the folks at Dexcom. They submitted to the US FDA at the end of 2021, no firm timeline on US approval. https://www.medicaldevice-network.com/news/dexcom-ce-mark-g7-cgm-system/ XX Some good news about living longer with chronic conditions, including diabetes. This was a 20-year British study that ended in 2011, so one caveat here, it doesn't include COVID. Men gained 4-point-6 years of life expectancy; women gained 2-point-1. When it comes to disability-free life expectancy, men gained about a year less and women stayed the same. This included people with chronic conditions including those with diabetes. These researchers do point out that while they'd expect to see the same increase in the US – the lack of health and social safety net programs could make a negative difference here. But they point to CGM technology and better medication as making a big difference for those with diabetes. https://www.healthline.com/health-news/why-people-with-chronic-conditions-such-as-diabetes-are-living-longer-without-disability#Cognitive-impairment-is-the-exception XX Children who develop type 1 diabetes show epi-genetic changes in the cells of their immune system long before the antibodies of the disease are detected in their blood. An epigenetic change affects how our genes work. Outside factors such as environmental, viral infections, are usually the cause. These researchers say these are previously unknown changes that signal the increased risk of developing type 1 and could give an even earlier indication than the anti-body marker tests available now. https://www.news-medical.net/news/20220316/Epigenetic-changes-could-be-a-biomarker-for-early-detection-of-type-1-diabetes.aspx XX Could text-messaging with their doctors help people with type 2? A new team in Chicago is looking at text-based intervention in underserved communities. The intervention will deliver personalized information directly to patients through text messages, including reminders about self-monitoring and prescription refills, interactive office hours and general information about diabetes, motivational support and answers to frequently asked questions. These doctors say the idea is to create more opportunities for patients to meaningfully engage and reduce barriers by employing technology already in people's hands. https://today.uic.edu/an-sms-solution-for-type-2-diabetes XX Last week we told you about the effort by Civica RX to make affordable insulin. Civica, is a nonprofit generic pharmaceutical company. JDRF directed funds to this effort and CEO Aaron Kowalski wrote an op ed that I'll link up. In it, he talks about the success Civica has had lowering the costs of other medications. We'll have Kowalski on the show soon and I've reached out to Civica as well. This would lower the price to $35 a vial no matter your insurance. Congress still hung on a $35 co-pay cap for those with insurance. https://www.healthline.com/diabetesmine/op-ed-jdrf-leader-on-insulin-affordability-for-all-americans XX Over in the UK they keep moving forward – covering all 400-thousand Britons with type 1 for the Libre CGM. Former guest of the podcast, Dr. Partha Kar, says everyone with type 1 will be able to get a CGM if they want one by the end of March. It will no longer be restricted by who doctors think need it the most. By the way, Briton means someone from England, Scotland or Wales. It's the first time I'm using that word so UK friends.. let me know if I've got it right! https://www.dailymail.co.uk/health/article-10606335/All-400-000-type-1-diabetic-Britons-offered-high-tech-implant.html XX Still a big need for diabetes help to Ukraine. A lot of the efforts are paying off – Insulin for Life showing that the supplies are on their way or have arrived. Spare a Rose reports that individual donations so far have totaled more than 115-thousand-dollars. I'll keep linking up places to donate https://www.jdrf.org/blog/2022/03/02/helping-the-diabetes-community-in-ukraine/ XX Reaction to Pixar's Turning Red. I loved this. I put out a call for photos of people seeing themselves in the movie's tiny little moments of diabetes representation. Thanks to all who sent those in – you can see them on Diabetes Connections on Facebook and Twitter. And my Stacey Simms account on Instagram. It's all just one account there. XX While Turning Red had diabetes in the background.. this week on the long format episode we're talking about a movie that wants to put type 1 front and center. And it's got the Star Trek community excited as well! Meet the Star Trek Discovery actor with type 1 who's leading this effort. Next week, we're going on a deep dive about stem cell research with the folks at Viactye. They're working on two fronts now.. encapsulation AND gene editing with the people at CRISPR. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

Diabetes Connections with Stacey Simms Type 1 Diabetes
Smaller, Smarter, & More Flexible: A look into Tandem's product pipeline

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jan 25, 2022 42:05


Take a deep dive into the future of Tandem Diabetes. In December, the company laid out an ambitious 5-year plan to update software, move to a smaller pump and ultimately a tubeless version. Company leaders say they want to think even bigger and we're talking to Chief Strategy Officer Elizabeth Gasser. We'll go through the short term changes Tandem has in the pipeline like the tiny Mobi pump and talk about philosophy and more. Tandem R&D Presentation (slides)  Tandem R&D Presentation (replay)  This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *DEXCOM*   Stacey Simms  0:00 Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 where Diabetes Connections are made. This is Diabetes Connections with Stacey Simms. This week, a deep dive into the future of Tandem diabetes. That company laid out an ambitious five-year plan to update software, move to a smaller pump and ultimately move to a tubeless version. company leaders say they want to think even bigger.   Elizabeth Gasser  0:37 we have thermostats that manage our home temperature for us. We have self-driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. Come on. We should demand that level of ease of use in what we're doing here as well.   Stacey Simms  0:54 That's Tandem Chief Strategy Officer Elizabeth Gasser. We'll  go through the short term changes Tandem has in the pipeline like the tiny Mobi pump, she'll answer a bunch of your questions. We'll talk about the philosophy of the company moving forward, and more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Welcome to another week of the show, I am only so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. back in December Tandem made a big splash with their very first research and development presentation. If you haven't seen that, I highly recommend that it is rather long, but it's definitely worth checking out. I'll link that up in the show notes. And you can always find out more at diabetes connections.com. But in this R&D presentation, they laid out a very ambitious five-year plan for the company, which we're going to go through and talk about in detail today. Quick date check for you This interview was taped on January 10 2022. And we're releasing it on January 25 2022. So as of right now, the FDA has not approved anything new for Tandem no Mobile bolus that is in front of the FDA, and we'll talk about that and so much more. There were a few questions I didn't have time to get to or that you sent in after the interview. So I sent those to Tandem and I will come back after the interview. I'll update you and answer what I can also after the interview, if you are a health care provider, a diabetes educator and endocrinologist if you work in those offices. And a very specific question for you. Please come back. I'll make it quick. But I need some information. And I know you will can help me. Okay. My guest this week is Tandem Chief Strategy Officer Elizabeth Gasser she says Call me Liz. So I do. Her background isn't in diabetes, it is in strategy and corporate development, working at Qualcomm in their internet services division and at open wave systems, the world's leading Mobile browser provider at that time, and we talk about what it's like to come from that world to this one, I think it's really important to kind of get an idea for these individuals, you know who they are, who are making these decisions that affect so many of us. And of course, we go through that 10 to five year plan product by product.   Liz, welcome to Diabetes Connections. Thank you so much for joining me, we have a lot to talk about today. Thanks for being here.   Elizabeth Gasser  3:24 Oh, my pleasure. I'm excited to chat.   Stacey Simms  3:27 There are a lot of items that Tandem announced in December, there's a lot to go through there. But I wonder if we could start kind of by backing up a little bit I've heard that you Tandem is kind of talking about being less of a hardware company, right, the pump, which will always be there in some way, shape, or form. But thinking more about the software, can we step back a little bit from the products here and talk a little bit more about kind of the philosophy or the vision? Oh, happy   Elizabeth Gasser  3:53 to and if you've watched our R&D day, you'll you'll know that I do enjoy expanding on this particular topic. You know, as with any connected device, the minute you take a piece of hardware, and you give it a cellular connection or or a Wi Fi connection or a connection to the Internet, you've opened up the potential way to do an awful lot of creative things with both data but also with software, it really opens up the potential for continuous update functions and capability. And then also the ability to pull and push data back and forth from a device and and once you've done that, you you really crossed into that that world of the Internet of Things which requires you to be both an excellent hardware company, because you're managing the device, the functions of that device. It's touchpoints through connectivity, but it also requires you to be an excellent software company along the way. And if you look at the Tandem journey over the past five to seven years, you really do see the company's products moving down that pathway. Of course, the pump remains front and center for us it you know, the delivery of insulin is what we do. It's how we bring that therapy benefit to our users. But you also see a start to do things like the ability to update the pump software itself that unlocks new features and functionalities, including the algorithms which we can now continuously update, it allows us to update the different types of devices we integrate with, you'll see we've obviously moved from supporting Dexcom, G5, two, G6, and we're moving to G7. That's all done through software updates. And so it's really hard to be in this space and to be talking about connectivity and connected devices without also embracing the fact that you really are a software company and have to be incredibly good at it to deliver the value that you want to deliver to your customer base.   Stacey Simms  5:59 I do remember years ago, our first pump and I say our work has been he was to when he got it. So it was definitely it was a group effort. But it was the Animas pump. And then a few years or months who remembers after he got that there was an update, where you could bolus from the remote meter. But we had to wait until our insurance would cover until we were up for a new pump. We had to wait I think three and a half years before we could get that. And so when we switched over to Tandem, I think we had the pump for a month when we there was a software update. So it really has changed. And to your point it is it is really remarkable to see that. Let's talk about, as you mentioned, the R&D presentation and some of what's in development. And of course, the usual disclaimer, I am sure that a lot of what we're going to talk about here is in development, it is not FDA approved. So there are limitations, I'm sure about what you can and cannot speak about. And if you can't answer something we totally understand. But let's just jump on in and kind of go through a list here. My listeners are extremely interested in getting some kind of update on the bolus by phone, which is in the FDA hands. But I have to ask you about   Elizabeth Gasser  7:07 I figured you would like the the world is obviously a very unpredictable place these days, not least when it comes to projecting FDA timelines. That said, we still feel very confident and we're planning on an early 2022 approval. So I can't say much more than watch this space. But we're still leaning into the timelines. We talked about it R&D Day and looking at getting this much requested feature to our user base as soon as we can.   Stacey Simms  7:39 Can you share with the rollout process may be? In other words, will it be a simple update to the T Connect app? Will there be some kind of required or prescription required online patient training?   Elizabeth Gasser  7:49 Yeah, happy to and this this kind of ties to the conversation we were just having about, you know, being a software company, right? The introduction of this feature will be straightforward software updates. And so what does that mean? In practical terms, that means updating the iOS or Android Android application to the newest version, which will have the Mobile bolus capability. And at the same time, making sure you do a pump software update so that both sides of that dialogue can happen. And as part of the pumps software update, which happens through the Tandem device updater. There will be some online training, music click through to make sure that they understand the capabilities that we're introducing. And many of our users will be familiar with how you do that.   Stacey Simms  8:33 Would there be a prescription needed for that kind of feature? A   Elizabeth Gasser  8:36 Mobile bonus? Yeah, no,   Stacey Simms  8:39 this may be a silly question. But can you share any details of what Mobile bolus actually means? In other words, I visioned this as Benny will take the his phone out and have full functionality controlling the pump from the phone. Is that accurate?   Elizabeth Gasser  8:53 Yes or no, in that the primary goal of Mobile bolus is to allow for the delivery of a bolus from the phone. So in that sense, you're absolutely right, it will become for most of the day, the app will be the vehicle through which you can interact with the pump the piece, it won't do his full control of the pump. Meaning when you need to go in and look at changing settings, for example, that's not going to be in the Mobile bolus release. That's something that you don't have to do all the time, and can reasonably be done by taking the pump out and using the user interface on the device. As we get to the movie launch. Obviously, that will not have a screen. And so those control features, what we call full control will migrate into the app as well, for the movie pump.   Stacey Simms  9:46 Of course, yes, that makes perfect sense. I'm not going to let myself get too far ahead because boy do I want to ask you about but to just stay on on Mobile bolus for one one or two more questions, but with Mobile bolus are there other There are features that will be on the phone, obviously, it   Elizabeth Gasser  10:03 will marry with the app that currently exists today, right. And so that that is predominantly today, a secondary display tool allows you to see all of the things that are going on with the pump allows you to see blood glucose readings allows you to see insulin on board allows you to see the insulin delivery that you've conducted through the day. And so all of those features will remain. And the focus here really is on augmenting it with the ability to deliver a bolus from the phone. And so that sort of feels like it downplays. No. But it's incredibly, it's an incredibly exciting augmentation, and one that we think is an incredibly important first step towards that for control. Because it is the hardest use case, we have to get that absolutely right.   Stacey Simms  10:49 Will that have share and follow? Is that something that you're working on for down the line? Or is that something that may come sooner? So really   Elizabeth Gasser  10:56 good question. And we do recognize that share follow is incredibly important to our users and their families. Were continuing to look at where explicit share and follow capabilities for on our roadmap and what the best path to implementing that is, in large part because there's a diversity of CGM follow options out there, including our own Sugarmate application, which which can be used for blood glucose monitoring in a follow capacity. And so we don't have roadmap dates to share at this point in time, just know that we're sensitive to figuring out what the best possible implementation is for our customers here. And we want to make sure we're getting as much experience as we can, in the meantime, really understanding how to do good follow. And as I say, we're getting some of that through the Sugarmate app that we're operating, which actually just went live with the Dexcom real time API, right. And so there's a little complexity to thinking through what the best implementation model is. We're working on it and watch this space.   Stacey Simms  12:00 Well, since you brought up Sugarmate, I have to ask with Sugarmate, which is if it's not clear, Tandem owns as you said, many people don't realize that is sugar beet, something that people could use, kind of as a bit of a workaround for a Tandem share and follow or Sugarmate only displays Dexcom data right now.   Elizabeth Gasser  12:18 So today, sugar is explicitly a CGM companion application. It displays data from the Dexcom CGM. Over time we're looking at what features need to be added to that to ensure it delivers the best value proposition to our users. Really interesting   Stacey Simms  12:33 stuff. All right, you segwayed beautifully into my question about Dexcom. How soon after Dexcom G7 is FDA approved, do anticipate it being available on the x two and again, is that a simple software update?   Right back to our conversation, but first Diabetes Connections is brought to you by Dexcom. just about to talk about there. And one of the most common questions I get is about helping children become more independent. You know, those transitional times are very tricky elementary school to middle school middle to high school you get but I'm talking about using the Dexcom has made a big difference. For us. It is not all about sharing follow. I mean, that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to show their care team the number before Jim at one point, but he was up to 10 finger sticks a day and sometimes more and not having to do that makes his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo. And now back to Liz I just asked about tandems planned integration of Dexcom G7 when it is approved and released.   Elizabeth Gasser  13:53 We are intending to implement Dexcom G7 With both pump models so that means X2 and that means Mobi, down the road, our current goal, and this remains our goal is to deliver that within a quarter of FDA approval of the G7. And in terms of how they gets rolled out. I mean, it's very consistent with the software conversation we were just having right. The beauty of the software model is you know, as that gets approved, and as the implementation is ready, we'll be making it available to customers through a simple software update.   Stacey Simms  14:26 Let's move on and talk about the December R&D presentation where this large plan, I think very ambitious and exciting was laid out for the next five years. And we've already mentioned a couple of the products. We're going to go through it in some more detail, but I am curious kind of, you know just what it was like that day and if you didn't see it or hear it, I can link up the video. I'm assuming that it's still up there. But I guess I'm asking this is what were you all talking about that day? There were so many people involved in the presentation, kind of doing handoffs and saying, here's the product, here's the software, here's the philosophy, it had to be a big deal. Tandem had to be a lot of relief when all the technology worked. And everybody got their presentations through with it. You were done.   Elizabeth Gasser  15:07 Oh, absolutely. I couldn't agree more with that sense of it was momentous. And certainly at the end of it, we're all pretty tired. But no, it was, it was exhilarating, too. And I think, you know, we spend a lot of time because of because we're in a regulated space, we spend a lot of time talking day to day about the here and now the stuff that's approved, the stuff that's in market, and the reality is a lot of what we shared R&D day we've been working on for a while now. And you know, some of it's been skunkworks. Some of it's been more formal programs, you know, you just ticking along. And it was really exciting to have a vehicle to share a lot of that thinking and a lot of that innovation that we get to see day in day out. But we don't always get to tell the world about because of the rules and regulations in our space.   Stacey Simms  15:59 Alright, let's talk about it as much as we can. You've mentioned Mobi several times, this had been referred to and I had been told this was not gonna be the name. So we didn't know that. But this had been formally referred to as T-Sport. Now, it is Tandem Mobi. Can you go through the features? Can you go through what this product is?   Elizabeth Gasser  16:19 Absolutely. Where to start? First at it. It's the world's smallest durable pump. So if you're familiar with with the X2, it's half the size, that's really small, durable, four year lifespan hardware. So that in and of itself is exciting. In terms of where we go with the software on top of Mobi, it's going to support Control IQ. So same great algorithm that's in market today, it will be deployed on on both pumps in the same way. And so we get to bring that algorithm across the entire portfolio when Mobi launches, it will be controlled by phone as we were talking about earlier. And that means full control at this point in time, obviously, because there's no screen on the device itself. So what does that mean? Everything you need to do to interact with the pump settings, whether it's bolusing, whether it's looking at your statistics throughout the day, that will come from the phone, it will be charged inductively, which that you know, not something you don't really focus on. But that's that's pretty cool. With we're getting used to wireless charging for all of our consumer electronics devices not having to hunt around for a cord to plug it in. That's what we're doing with with Mobi as well. It'll sit on a little charging station, very easy, very straightforward, less pieces to worry about on pump bolus button. And this one we think is a little differentiated. Certainly in the on body arena, I think it will be the only one only pump out there of this size that has the option to fall back to a button push on the pump just to make sure because obviously, when you are interacting with your pump solely through a phone, we need to build in some measure of failsafe fallback, right if you find himself without the phone, and needs to bolus. And then lastly, waterproof. We're going to support waterproof capabilities through IPX8, which I think is pretty competitive. So lots of stuff packed into a really, really tiny device.   Stacey Simms  18:25 I'm sorry, what is IPX? Eight mean?   Elizabeth Gasser  18:28 The best way to articulate it, it's really just the standards we comply with and IPX eight means fully waterproof, you'll be able to swim and shower with it.   Stacey Simms  18:36 One question about Mobi is I'm trying to visualize how it connects. My understanding is that it uses the standard pumping fusion set that like my son's Tslim currently uses, is that correct? It just sits closer to the body.   Elizabeth Gasser  18:51 That is correct. The Mobi pump will work with the Tandem portfolio of infusion sets. And with the Mobi pump launch, we will also be introducing a shorter infusion set that four or five inches long, that allows for greater diversity of wear options.   Stacey Simms  19:09 I'm so fascinated to see how this works because I'm a very visual person. So he could put it on like my son could put it on his arm and it kind of dangles off. Does it also stick to the body in a way? Or does it just kind of hang there on the tubing, the tiny tubing   Elizabeth Gasser  19:24 work, we're working on the accessories to allow for a diversity of wear options, whether the belt clips or sleeves or a body worn adhesive patch through which you can that you can pop the pump into. So there's a variety of places you can push   Stacey Simms  19:39 it interesting, alright. And like I said, I will link up so you can you can really dial down if you want to and see all of the features of everything we're going to talk about. But just for time limitations, we're not able to go through every single thing. Let's move on to the T slim x three that seemed to be next in the pipeline. What is that?   Elizabeth Gasser  19:55 x three. That's the next iteration for the T slim X To pump. And really the focus there is to continue really honing the capabilities of the T slim form factor, right. And so we recognize that over time t slim continues to play a role in the portfolio, many of our users will continue to want a pump with a built in user interface. And so really the x three programs emphasis is on further developing the processor capabilities of that device, looking at battery life, looking at durability, reliability, looking at wireless software update capabilities, really to make sure that the T slim x two kind of line has continued vibrancy as part of the portfolio over time. And we're making the appropriate investments to support the diversity of software and user interfaces that we want to bring to the portfolio at large. So   Stacey Simms  20:54 right now, it sounds like the changes you're talking about aren't something that, you know, I would look at the pump and say that is significantly different, right? Or that works completely did you've changed at all, it's making small improvements and things that the user, frankly, may not notice? Or will they're, you know, things will just run better, like you said battery life, that sort of thing. Are there significant changes that you could think of that would be coming to the pump itself?   Elizabeth Gasser  21:16 Oh, no, that's absolutely right. I think this one's a little fun for me, because I come from the consumer electronics space, originally and spent 20 years you know, working on phones. And as you think about the types of releases, you do with consumer electronics, year to year, a lot of them are under the hood, that it's really focused on making it connect better, giving it more horsepower, making the battery last longer. And those things aren't always visible on the surface to a user, but may manifest through the quality of the user experience they get from interacting with that device.   Stacey Simms  21:50 The next product is Mobi tubeless. We've talked about what Mobi is, I'm assuming this means know to tell me a little bit about Mobile tubeless. This is   Elizabeth Gasser  22:01 a certain creativity and the naming convention there isn't so   Stacey Simms  22:06 we shouldn't laugh. It's a very big deal. It's a very big deal.   Elizabeth Gasser  22:09 No, I say that affectionately. And look, it's back to the conversation we were having on kind of the Mobi, shorter infusion set and different Bodywear options, more ways to air Mobi, right, we recognize that not everyone ultimately wants a pump with a tube. And so we've been pushing ourselves to say, okay, how can we improve the wearability and the wear option, so that we're reaching the broadest possible base of customers here. And, and this one's kind of an example of the things that we've had in the hopper for a while that not everyone gets to see, we took a little trip in the Wayback Machine and dusted off some of our earliest thinking on movie here. And maybe a tubeless infusion site option has been in our minds for a while. And so we felt it was the right time to bring that idea back to look at how to make it a reality as we get closer to the official launch of Mobi. And so this sits in the roadmap for Mobi as additional ways to utilize and engage with the product. And hopefully, it will give users choices, right? Some days, I don't want to wear my pump on my body, I might want to have it in my pocket and connect via a standard infusion site. Other days, I may be a little more active and find a really need to have a have a tubeless wear option, we get rid of the tube, the goal for us is to satisfy all of those use cases.   Stacey Simms  23:34 And then the last one is the completely disposable patch pump that's in the pipeline. Is this a different form factor than Mobi? Is it a different design? Or is it similar?   Elizabeth Gasser  23:44 So this is a different program? I can absolutely share that. I can't say a whole lot. This is one we want to keep fairly tight under wraps for competitive reasons. But the emphasis there is is very much on miniaturization. Got it. Can we really push the design envelope here on form factor for the device?   Stacey Simms  24:06 You know, it's so interesting. We've been in this community as a family for 15 years. So now you're certainly not as long as many other people but in that time, we've seen and heard a lot of products, right? We've heard about new things coming. We've seen some really great advancements, we see things go away. This is a very ambitious portfolio that we're looking at and five years is it doesn't seem like a long time really certainly as I get older, it seems less than less. Seems everything's going more and more quickly. But a lot can happen in five years is the is the plan here that all of these products will exist together. As you said, you know, the movie tubeless you kind of made it sound like I might be able to take out my Tandem movie with the longer tube and then switch to the tubeless another day is the idea that all of these would exist side by side.   Elizabeth Gasser  24:50 That's a great question, Stacey. I think the best way to answer that is to really reflect on the fact that we do fundamentally believe the day Diabetes space and particularly insulin dependent diabetes is a far more segmented market than every industry analysis would lead us to believe. You know, we often talk about type one and type two, as if those are the only segmentations that are relevant, we do actually think there's various needs, that we should appropriately be segmenting around, including, where preference form factor and user and interface size. And so as we look at the portfolio, we're really looking at how we can satisfy the broadest array of user needs. That may mean there is on occasion, some overlap in functionality between different products that sit in the mix. But the goal is really to provide the right device for the right group at the right time. And so as we think about where we go from here, the roadmap as we have sketched it out, for the 22 to 27 period really is very much about a tube pump offering with a screen, that's Tslim X2, a smaller form factor, more discreet phone operated screen, this option in the form of Mobi and there, the goal really is to create as diverse an array of wear options as we can to satisfy the needs of different user groups and their day to day activities, and then pass that as you think about the idea of a passionate disposable patch that exists as a third category that overtime will, we'll have to see how these different offerings play out with the segments that they're serving, and they are likely to coexist.   Stacey Simms  26:39 So interesting. As we begin to kind of wrap this up, I did have a couple of questions from listeners I wanted to get to, and one of them was about control IQ, frankly, and any changes coming. In other words, we had heard a lot about changing the adjustable, changing the target rates lower than 160 and 180, that they are right now not the target rates. That's when the pump takes action, that kind of thing. And I remember hearing that there was something in front of the FDA, I don't know how much you can share. But can you talk to us about changes coming to control like you, yeah, happy to   Elizabeth Gasser  27:09 talk about the design goals. In terms of control IQ today, it's delivering great outcomes. And in its current instantiation, I think one of the things that's helpful to understand about algorithms is that they're all going to work in different ways. It's like chocolate chip cookie recipes. If you think about it, lots of people have them, but it's how you put the pieces together and in what order and it's the secret sauce that affects how it tastes. Similarly, with algorithms, a lot of it comes down to how you put it together. And it's not always practical to compare from one to another. The real test is, you know, are you getting users to where they need to be in terms of, you know, being able to achieve their time and range goals, for example. So I think it's worth wrapping your head around that idea upfront. Now, having said that, for the control IQ roadmap, our next development frontier really is very much around personalization, and usability. While we're not going to get into very specific, you know, roadmap feature intersections at this time, we're exploring quite a bit here. And Jordan alluded to this a little bit in our R&D Day discussion, part of personalization for us does include exploring lower target ranges, and personalized target ranges, and looking at what it would take to deliver on those capabilities.   Stacey Simms  28:32 Here's a real speculative question that I don't expect you to answer. I'm hearing in the DIY space, that more and more people are coming up with algorithms that don't need meal announcements, or don't even need meal boluses. Is that something that Tandem is working on for an algorithm? Or I guess the real personal question is, could you please Liz, help me because my son forgets to bolus for many meals. He's 17. He's very independent. But oh my gosh, when I see people working on things like that, I just feel like that would be life changing.   Elizabeth Gasser  29:05 Yeah, mail handling unannounced meals on lounge consumption. Yeah, it's the hardest thing to confirm it with the algorithm here. It is fair to say that as part of our ongoing roadmap explorations, we are looking at what it means to improve unannounced meal handling.   Stacey Simms  29:24 I'll take it. I'll take it. Thank you. Another question came up about new infusion sets. And you had mentioned this, you touched on this briefly, but we talked to folks at ConvaTec who make many of the infusion sets and they were talking about longer life improvements to the cannulas or those sorts of things coming to Tandem. Yeah, so we   Elizabeth Gasser  29:46 did talk a little bit about our goals here. During R&D day. You know, it is only one piece of the system but we do recognize infusion set issues can be a real pain point for customers and so we have programs IPs that are ongoing. Some of them are internal driven by us. Some of them are in conjunction with our partners working on a diversity of things. Some of it is extended wear time, which we know is important. But we're also looking at insertion, ease and usability there, we're looking at how to reduce infusion site failures, specifically around occlusions, obviously continuing to look at things like adhesives, reduction of material waste. And so this one, it's a pretty diverse view that we're taking. It's not all necessarily anchored solely in the idea of extended wear, I can't give you any specific breaking news in terms of you know, what we're coming up with and the products we'd like to bring to market. But this one we're paying serious attention to, we recognize that our customers want to see progression here.   Stacey Simms  30:57 Yeah, I have been amazed since day one of pumping, I feel like the infusion sets have, at least for us, and everybody is different. And everybody's skin is different. Everybody's insertion technique is different, which is part of the problem. But you know, I've just been amazed to me, that has always been the weakest link of pumping. And the idea that I'm using pretty much the exact same infusion set that I put on my son's body 15 years ago, just with all the advances that we've had to me, that's the one that needs much more attention. So I'm really, really glad to hear you're working on that. Alright, so this is not a question. But this was a thought that ran through many of the comments. Many people wanted to say, thank you for getting this is terrible. Thank you for getting control IQ through the FDA before COVID. Because oh my gosh, nothing has happened since like, this was approved, what December of 2019. And many people started getting it I think the earliest was January of 2020. And the diabetes community it feels like very little, although there have been there have been approvals. But it feels like everything is moving so slowly now. So I'm sure Tandem is happy about that. But I know the community as well. So I'm not sure if I can even ask you to answer. There's no question there. But thank you.   Elizabeth Gasser  32:05 Oh, I'm not sure there's any good answers there either. Stacey, I certainly applaud the the yeoman's work going on at the FDA to manage through this crisis. And certainly while it's frustrating to have extended approval cycles, and yes, in retrospect, a blessing that we secured approval prior to COVID. I can't do anything but feel respect, admiration and a little bit of sympathy for our friends at the FDA. Yeah. And   Stacey Simms  32:35 again, I don't know if you can answer something like this. Have you heard that they are they're kind of making their way through it just seems like there was such a log jam, I understandably so any feeling any word that they are kind of clearing the deck, so   Elizabeth Gasser  32:47 to speak? I don't think it's my place to comment on my workflow there. I   Unknown Speaker  32:50 tried. You can we do have good   Elizabeth Gasser  32:52 back and forth with the FDA, you communicate with them regularly. And so they continue to engage with the industry constructively, productively.   Stacey Simms  33:02 Alright, before I let you go, you don't live with diabetes, as you said at the very beginning, you know, you come from a software background and that sort of thing. But what is it like to come from that and work in in diabetes, where the work that you do I mean, here I am complaining about infusion sets, and, you know, change the bolus, from what you know, before it reaches 180? You know, we're talking about all of these little things add up to such quality of life issues for people, you know, what does it been like for you to work in this space?   Elizabeth Gasser  33:28 That's a great question. It's one that I think you're the first person to ask me to reflect on. You know, I think it is both sobering and invigorating, sobering because, you know, when you come from a world that's, you know, focusing on clicks and engagement and eyeballs, and consumption of media, you can get lost in the little things, and really stepping back and recognizing just the enormity of what type 1 diabetes is, and the burden it places on people's lives, day to day, and feeling like I can show up to work and even in a little way, help with that. That's sobering and profoundly rewarding. It's also invigorating, because, you know, coming from a consumer electronics environment, you see what's possible with the technology as it exists today, and many of those technologies have not yet come to medical devices in a very fulsome way. And so I certainly get out of bed day in day out wondering how we can help therapy benefit from all of the innovation that is going on, in the consumer electronics world, right. You know, we have thermostats that manage our home temperature for us. We have self driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. I don't mean to trivialize the differences that are involved in translate I think that to medical devices, but I also think as you look at that and say, Come on, we should demand that level of ease of use in what we're doing here as well. And so that that's profoundly motivating.   Stacey Simms  35:13 That's great. Well, thank you so much for sharing so much information for answering what you could answer. And I hope we talk again soon. My pleasure.   Elizabeth Gasser  35:21 Thank you, Stacey.   Stacey Simms  35:27 You're listening to Diabetes Connections with Stacey Simms more information at diabetes connections.com, including the link to the research and development presentation. If you'd like to watch that or just listen to it, I will link that up over on the website along with the transcription. I really appreciate your patience with the transcriptions. I think we do a great job. But my transcription software doesn't speak diabetes, I try to teach it but it is a little unreliable. That way we go through and try to catch the big stuff. But if you do see anything egregious, or very confusing, please let me know. And I can pretty easily fix that. I want to take a moment and address a couple of the questions that we ran out of time with Tandem or your questions came in late. I'm going to do that in just a moment. But first, I mentioned at the beginning of the show that I had a question for healthcare providers, I have a question for you, I have a favor to ask of you. You may have heard me talk about Club 1921. I mentioned it right at the beginning of the show, I'm only talking about if you're at the end of some of the podcast episodes, and in the Facebook group, we are in beta. It is my new project. It's all about events in the diabetes community nationwide, any type of diabetes anywhere in the United States. I need your help, because it's very easy for me to find the big events, right friends for life, JDRF, even ADA stuff online. What I would like to add to the website, and what I think will be vital to its success are all of the events going on in your hospitals. Almost every hospital has a nutrition program for people with type two, an education program for gestational diabetes, things like that. They can be virtual, they can be in person, but I need to find those programs, I need to get into those hospitals, I need to reach the people who want to add those events. This is not a community calendar, where I hope a couple of groups post their events. And we all go from there. I want this to grow into a site where 1000s of people with diabetes, any type of diabetes, find their community find help find what's being offered. And I know that these hospitals want to connect with these folks. So if you could help me do that point me in the right directions to meet with the association's it doesn't have to be one on one with hospital systems, although that would be great, too. But whatever you think might be a help, I would really appreciate it, you can email me Stacey at diabetes connections.com, you can message me on social media, thank you so much, because this will only succeed if we reach out beyond the community that we are already talking to. So thanks. Okay, let's get to the kind of leftover questions from Tandem, the most common one had to do with international rollout. And I unfortunately, I don't really have any good answers for you. I'll tell you what Tandem said I asked specifically about Australia, I had two people who emailed me asking about what is going on in Australia with the rollout of Control, IQ, nevermind all these other features. And they just said we do not have an update at this time. And then asking about other international markets. So let me read that response in full Tandem says we have launched in a large majority of the international markets, and we're near to medium term focuses on ensuring we work to make our technology broadly available to these customers. We don't have anything to disclose with regard to additional markets at this time. So I know not the answer you were hoping for. I will keep asking on this one. And I do apologize, we are a very US centric podcast because I am US centric. But I appreciate the reminder. And I will try to keep that focused and you know on my list of questions as we move forward with lots of different technology this year. And then I had also asked them about changes to the current controller queue algorithm. I had asked during the interview if it could take action at a lower number than 160, which is where it jumps up to basil and 180 where it gives an auto bolus at 60% of the bolus rate that the person programs in and Liz did answer that question in the abstract, but I wish I had pushed on it. So I followed up because I thought I had heard that Tandem had already submitted a change on that to the FDA. They responded quote, as Liz mentioned in the interview, we are working on personalization features which include lower targets and thresholds. We've begun to engage the FDA and started our design work, but we're not currently providing any of the feature details and quote, I will add this editorial comment. Every pump company I talked to has started out saying we're going to have lower ranges, we're going to have tighter ranges, we're going to have customizable ranges and every time it hits the FDA that kind of starts to change set You know, Omnipod, if you'll go back and listen to the interviews from two or three years ago, they were going to submit with I think it was 80 to 100 as one of their ranges. And that didn't happen they've submitted with higher ranges, just like Tandem did. I think, again, this is my speculation, I think these will all gradually come down. But if you are looking now for tighter control with these hybrid closed loops, you might want to go the DIY route. Although if you keep your pump in sleep mode, you know you're sleeping beauties with Tandem it's trying to keep you at like one 12.5 The whole time you just have to remember to bolus which works beautifully for some people, and not at all for the person in my house.   Okay, before I let you go quick look ahead. Of course in the news is every Wednesday we do that live on Facebook, and YouTube and I added LinkedIn this week. My goodness, we're also live on Instagram a little bit later, still can't do all of that at once we're working on it. And then I turned that into an audio podcast episode that is released on Fridays, upcoming longer format shows we'll cover more technology including a new pump called Sigi. We've also got some really interesting community interviews. What is it like right now when you live with type one, but you also live with another autoimmune condition that makes it very difficult to get a COVID vaccine. And I'm going to be talking to some of the Joslin medalists who are this is a theme right living longer with type one and the issues that have cropped up for them that nobody really far, we would have to think about so I'm excited about that and so much more. Thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon until then, be kind to yourself.   Benny  41:48 Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged    

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. New G7 data, Lingo sensors, COVID & Diabetes studies and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jan 14, 2022 5:51


Every week "In the News..." brings you the top stories and headlines around the diabetes community. Top stories this week include: a Dexcom G7 data update, Abbott announces new Lingo sensors to measure ketones and more, it's 100 years since the first insulin shot, Lilly Diabetes discontinues T1D Everyday Magic and an ultra releases diabetes data to a medical journal -- Join us LIVE every Wednesday at 4:30pm EST Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below  Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. All sources linked up where you're watching and at Diabetes-Connections dot com when this airs as a podcast. XX Looking to get organized? Check out my new guide with top tips to clear your diabetes clutter. Everything from how to start to where to donate and how to keep it from taking over your house. Head over to diabetes-connections dot com to organize your diabetes supplies! XX Some new information about Dexcom's upcoming G7, which has been submitted to the US FDA and in Europe. Latest clinical study show the MARD of the G7 is 8.2 for adults, compared to 9 for the G6. MARD is the Mean absolute relative difference and the lower the better here. G7 was even lower, 8.1 for kids. This is close to the same results they talked about last summer, but the group in the trial was bigger. G7 is expected to get approval in Europe this quarter and likely in the US much later this year. Our last longer format interview episode is with Dexcom's CEO and we go in depth on this. https://www.drugdeliverybusiness.com/dexcom-ceo-touts-unprecedented-performance-of-g7-in-clinical-trial-awaits-fda-decision/?fbclid=IwAR3G5_Fu9fhPfR0M3FzgCNCsFYmo4gDRDy5nJySgxt56mMVJgrpUsVQedis https://investors.dexcom.com/static-files/0c3012e2-40f4-4046-a962-85e6b421d490 XX Two COVID and diabetes studies I want to talk about.. the first showing that more children are being diagnosed with type 1 and type 2 diabetes after getting COVID. This study looked at databases of people under 18 starting in March 2020 and going for 18 months. There are a LOT of questions here.. including whether post-COVID type 2 diabetes will actual be a temporary or chronic condition. Which leads us to the other study.. this one of adults, in almost 4-thousand covid patients, just under half developed high blood sugar levels, including many who were not previously diabetic. These researchers say a lot of the patients here were in their 30s and 40s, no sign of diabetes before COVID.. and the levels of glucose in their blood were incredibly high, sometimes more than twice the level that indicates diabetes. These patients still had high levels of C-peptide, which shows that they were still producing insulin. The theory here is that something is disrupting the fat cells. But the researchers admit they are just at the beginning of figuring this out. It's this latter study and others like it that seem to be showing that there really is something different about COVID and blood glucose. I saw a lot of people dismissing the children's study with, well, any virus can cause T1D.  I'm glad these researchers are digging into what's going on. https://www.sciencenews.org/article/coronavirus-covid-diabetes-fat-cells-blood-sugar https://www.nytimes.com/2022/01/07/health/kids-covid-diabetes-cdc.html XX Abbott unveils plans for a new line of consumer bio-wearable sensors that will collect a broader range of biological readings to help users optimize their exercise and nutrition regimens and overall health. Called “Lingo”- which are still under development and aren't intended for medical use— they are based on the existing Freestyle Libre diabetes monitoring technology. We're talking about glucose, ketones, lactate and alcohol. Interesting to me that these were shown at the Consumer Electronics Show and not a medical conference, but Abbott is up front that these are basically for athletes and not for people with diabetes or those who need to make medical decisions based on the sensors. We'll see which of these makes it off the drawing board. https://www.fiercebiotech.com/medtech/abbott-ceo-ford-unveils-lingo-line-sports-biosensors-based-diabetes-monitoring-tech XX Another divestment for Lilly Diabetes – last week we told you they were doing away with their Journey Medals for diaversaries.. they have since announced that T1D everyday magic is no more. This was a partnership between Lilly and Disney that was a blog and a place for recipes and the home of those Coco books, the cute monkey with diabetes who hangs out with Mickey & Minnie Mouse. As of today you can still get digital versions of the books via the website but we'll see how long that lasts. Full disclosure: I wrote for them a couple of times – and was paid by them – glad I saved those columns. https://www.t1everydaymagic.com/thank-you-for-sharing-the-magic/ XX Interesting news from an amazing athlete with type 1. We told you that Sebastien Sasseville biked across Canada this summer. He previously went up Mt Everest and did a brutal race across the Sahara. Now, all the data on his blood sugar during that recent ride has been published. It's in the Journal of Diabetes, Obesity & Metabolism. Sasseville wore the Tandem and Dexcom Control IQ system during the ride.. the article is about how using that kind of automated insulin delivery system can help ultra athletes with diabetes.   https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14629?fbclid=IwAR2JLTn9dGJu43have5EMqXkWlENuDgPFDQq6RrsbY7TJyRJV0aERsDxYbo XX This week marks 100 years since the first person received a shot of insulin. Canadian teenager Leonard Thompson got that life saving injection on January 11, 1922. Of course, this was via Dr. Frederick Banting and his team.. Thompson was drifting in and out of a diabetic coma and weighed only 65 pounds. He was 14 years old. The first shot was found to be impure and didn't work. But they were able to fix the problem and administer a second purer shot. Thompson only lived to age 27 but his actions helped save so many lives. https://www.healthline.com/diabetesmine/diabetes-care-joslin-100-years-first-human-insulin-shot#A-century-of-Joslin XX Before I let you go, as I mentioned earlier, the podcast this week is an update from Dexcom. CEO Kevin Sayer answers your questions about the G7 and lots more. Listen wherever you get your podcasts or if you're listening to this as on a podcast app, just go back an episode. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Diabetes Connections with Stacey Simms Type 1 Diabetes
"Different every step of the way" - A Dexcom G7 Update (and more) with CEO Kevin Sayer

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jan 11, 2022 32:24


This week, Dexcom CEO Kevin Sayer spoke to the JP Morgan Healthcare Conference about the G7 and beyond. We talk about information from that presentation and get to as many of your questions as time allows. This interview took place on Tuesday Jan 11 and much of what we discussed isn't FDA approved. Dexcom presentation info here Club1921 info here  Our usual disclaimer: Dexcom is a sponsor of this podcast, but they don't dictate content and they don't tell me what to ask their executives. Recent Dexcom episodes: CTO Jake Leach talks about Garmin, Dexcom One & more CEO Kevin Sayer talks about G7, Direct to Watch, Adhesive and more CEO Kevin Sayer talks about Dexcom in Hospital, G7, VA program and more Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below  Stacey Simms 0:00 Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921. Where Diabetes Connections are made This is Diabetes Connections with Stacey Simms. Welcome to another week of the show. You know I'm always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. And I'm talking with Dexcom CEO this week, it's Kevin Sayer, he is back to check in with us again. And in the interest of getting this episode out to you as soon as I could. It might sound a little different right here at the beginning. But Dexcom episodes are always so high interest that it really merits a quick turnaround. I didn't want to sit on this interview for a week. So here's the setup. Dexcom CEO Kevin Sayer gave a presentation to the JP Morgan healthcare conference, if you're listening as this episode goes live, that was just Monday of this week, January 10, the interview you're about to hear took place on Tuesday, January 11. My usual disclaimer Dexcom is a sponsor of this podcast, but they don't dictate content and they don't tell me what to ask their executives. I asked the Diabetes Connections podcast Facebook group for questions. And Whoa, boy, did you have a lot as always not a surprise. And I really appreciate you sending those in, I got to as many as I could, while also trying to include what the folks at Dexcom had really asked me to bring up there are some topics that they wanted Kevin to make sure to address. And I think we do a pretty good job of trying to reach a balance here. Kevin, welcome and Happy New Year, Kevin Sayer 1:46 and Happy New Year to you. Stacey Simms 1:48 Thank you. Well, this seems to have started out in pretty happy way on the headline, just from this week. Dexcom CEO touts unprecedented performance of G7 in clinical trial. This is after your talk at the annual JP Morgan healthcare conference. Tell me a little bit about that unprecedented performance data. Kevin Sayer 2:08 I'm happy to. And I just have to qualify it by saying no, I can't send it to all your listeners at the end of the call yet. We're still waiting for approval in Europe. And we have filed this with the FDA, I'm going to take you back a little bit, we made a decision when we were going through the G7 development process that we wanted to answer that performed better than G6. And all of our scientists looked at us and they go oh, really, you're sure because this is really good. And so we spent a lot of time new algorithms and new manufacturing techniques, there's a lot of things in G7 that make it different. We also wanted to validate that performance with a study that was so large, nobody could refute it. So as you look at the data that I presented at the conference yesterday, over 300 patients 39,000 Match pairs all across since one ranges and on the I CGM standard side, but with the 5% 95% lower bound, and even the absolute points, you can see we are well within all of the iCGM standards, which are very technical and actually are a very good measure of how a sensor actually performs in reality. And they were very thoughtful in developing these standards to try and pick the centers that don't work to put you statistically in a bind to whereby if you really aren't performing in the low range or wherever, you're not going to get that iCGM designation. We're very comfortably there. And the overall MARD in the study, Stacey is eight point, you know I it's in the low eight for adults and pediatrics. And if you start looking at the data, we gather the data sets in three periods, you know, days one and two, the middle days, four, or five and six, and the last days nine and 10. It's pretty low, I think it's below 10. In the first group a day, the first days, which are always a little bit higher, traditionally in our centers than the other days. But in those middle and end days, it's it's near seven, and strips for six. I mean, we have done something that I've been in this business for since 1994. I didn't think we'd ever do this when I started. As far as being this good. This is really, really good data. And we're going to continue to deliver the experience to our customers that they demand from us. So as you can as you think about an iCGM that's driving an automated insulin delivery system. And not only is the performance great, the user where it's 60% smaller, it's a 30 minute warm up. It's a new app. From our perspective, we've got a lot of the clarity data, your listeners will know about clarity. We've got a lot of your clarity data right on the app. There's new alarm configurations. Stacey Simms 4:48 I'm gonna just jump in with a couple of quick clarifications before we go on. You mentioned a number of there that went by quickly I apologize when you talked about the 300 people in this trial 39,000 match what I missed that one Kevin Sayer 5:00 matched pairs. That's where you compare the CGM value to the blood glucose value from the laboratory instrument. So the way our studies work is literally we draw blood samples from the individuals in the study at intervals, and then we actually match the CGM data to that laboratory blood instrument. So 39,000 points from these 300 people in this study were matched. Got it? Stacey Simms 5:27 And you mentioned the MARD mean absolute relative difference. Most of you, as you listen are very familiar with this, the lower the better for CGM G6, I, my understanding was G6 was in the low nines. This is 8.1 for peds. 8.2 for adults, as I'm reading it, that's right. I know you can't tell me I'll ask you anyway, why? What made the difference here? Is it sighs is it algorithm? Do you have anything you can point to? Or is that a trade secret Kevin Sayer 5:49 it's combination, I think the algorithm has been the most, the algorithm changes were really extensive here. And, you know, we always have manufacturing processes to get better, the way we build the G7 centers different in every step of the way. Literally, our G6 manufacturing processes go away and the G7 ones take over the summer, we're a little similar on the actual sensor wire itself, and that manufacturing, but everything else is different. We just think it it's smaller, it's a lot shorter than G6 was. And so it is it's going to be a completely different experience for everybody. Stacey Simms 6:28 So to go back to what you were talking about, before I jumped in there, you were starting to talk about alarms, is there something different for the alarm, Kevin Sayer 6:35 the app is different. And so access to them, and, and just how you use them, if we try to get to be more consumer, thoughtful, as we configured the alarms, we'll see how everybody loves him. It'll be interesting. The alarms are one of the things we get the most comments on when we launch a product initially, we try and please everyone, but we never please everyone. And then you get you know, the agency at one time. I don't know if your call. I think one of our other discussions, we had to make the mute override not work on the low end. Boy, we got a lot of people mad at us about that one. So we've tried to comply with what our users want, and also comply with what the FDA has asked us to do. But I think users will find the alarm experience. Good as well. I like I think it's just gonna be a home run. Yeah, well, I Stacey Simms 7:24 mean, my son would be happy if an alarm never made a noise again. And I know other people who put like it to alarm every time there's any movement. So I hear where you're coming from, can you give any insight into the G7 app in terms of what the differences that we may see as users? And I guess especially one of the questions I always get is about follow any changes of significance coming that you can share follows Kevin Sayer 7:47 on a separate software track. And so the G7 system, the app is just we tried to get more data in the app itself, versus what we have with G6. So a lot of the clarity data, or at least summary query data is sitting there right in your app. And that will be i we think people will like that just to see how they're doing over time you got your time in range data for, you know, three 714, you know, a month, 90 days, see how you're doing time in range wise and the app is other than that it's relatively similar. The startup is different and you know, in the interface is going to be different. I think over time, what you'll see with us is that app is now going to get more sophisticated, we changed the entire software platform for G7 and started over again, and we developed a software platform, we can now really change and add on to a lot easier than we could in the past. And so we're hoping to have more frequent software releases. But we've also learned that CGM is not like Battlestar Galactica game, a game where you want to get a new release every two weeks to fire everybody up. We can't do a release every two weeks, because people depend on this for their, you know, for their lives. And if you do too frequent releases, and you botch a release, you do some wrong, you remember what happened, if we ever make a mistake on the software, the data side, we can't do that. But we do want to add more features more quickly in this platform will enable us to do that. I think one of the things you'll see going forward on the software side, we really want to automate a lot of the tech support features. We've added some, you know, you can get FAQs right from the app now with respect to your sensor, but there are other things we think we can do tech support wise in the app that will you know, reduce everybody's burden. Nobody likes making a phone call and nobody likes picking up the phone. And when we have a sensor fail, and we do have sensors fail, it just doesn't make any sense that you have to call us if we've got data on a phone, it'd be much easier. For example, if we could diagnose that failure right on the app and go through a very quick process to why but where you could get one. I can't give a timeframe when all those things are going to come but the platform is robust enough that over time, we can add features like that. One of the other nice things about G7, since it's fully disposable, you know, every sensor has its own unique serial number. Whereas with G6, that same transmitters used with three months' worth of sensors. So it will be, it will be fun to be able to follow things like that and see how the sensors go through the channel where everybody gets attract things of that nature. So what we're really looking forward to the change in our business that G7 affords us. Stacey Simms 10:28 As usual, I have listener questions, I'm going to try to not repeat because you've been really accessible in the last year, we've talked to a couple of folks from Dexcom, besides yourself. So as you listen, if I didn't get to your question, or if you have a question, good chance, we actually answered it in the last year, year and a half. But given let me ask you about compression lows, because that's one of the things we had talked about, about testing the G7. Any update on that in these trials, if you lay on it, you know, circulation slows, and you can get a false reading any better with the G7 Kevin Sayer 10:54 part of the clinical study is in the compression, because you're pretty much sitting in a chair with a needle in your arm drawing blood. So I'm sorry, we can't really test that we'll learn more about compression when it gets in the field. My hope is that it isn't as much but I can't promise that because I don't know, we're not enough people. I think there are ways over time where we can manage compression better, I'm not going to get into all the science on the phone, believe it or not, I do spend a lot of time with the engineers on this specific issue. Because I have it happened to me from time to time too. So I will call them up say Hey, can we do X, Y or Z? And I think there are some some answers, but I can't give them away because I don't want to give away the playbook. So let's let's just see what we can do overtime on that one. Stacey Simms 11:42 Okay. All right. But you know, the next clinical trial just have them lean against the side of their bed. Kevin Sayer 11:46 We will we'll have to do well. Diffic very scientific. Stacey Simms 11:50 Another question came up, and I think I'm gonna knock wood. I think we've been very lucky on this. It's about new iOS launches from Apple. And I'll read the question and it'll tell you, briefly our experience. This person said Dexcom is part of the Apple Developer Network developers have access to new release such as iOS months before launch, why does Dexcom lag behind Apple iOS launches by months in terms of quote, approved use. And our experience, frankly, is that we have not had any issues Benny and I both have, we just got but as a 13. Plus, we both had very old phones. And we have a latest software and no glitches for us. But that's not everyone's experience, can you talk a little bit about that, Kevin Sayer 12:30 we do get the iOS versions in advance, and we do our best to comply with them, I would I would tell you that it isn't as simple as it's made out to be. And the iOS version that's launched isn't always exactly what we've worked on as they as they make tweaks, not big ones. But you also test for everything that you know about the new iOS versions, and sometimes are things that you don't know, that are in there that come back and may affect the app later on, which is why we delay a little bit, we try and go through every bit of testing that you can imagine. And I'll be honest with your users, Apple's made iOS changes, because of us, we have called up and said, Look, you got to do XY and Z here we have a problem. And they're very good to work with, they've not been difficult at all, you know, when you think about iOS and Android operating system and all the things that they impact. And it's very hard not to impact somebody adversely when you do a new iOS launch. And you know, the perfect example with us is the home you'd override journey that I brought up earlier. In the beginning, I believe the only app that can overcome the mute override within iOS is authorized manna in the beginning was Apple's alarm clock, but other people would go around it with their apps was a medical device, we can't do a go around, we have to make sure what we do is in compliance and known so they work with us very well to make sure we could do what the FDA wanted with respect to the mute button. And the same thing with Android on that, and that was a very difficult exercise. So if there's a delay, it's because we're taking time to see what might have been put into iOS that would change our app. And it just one more thing that will stop. new operating systems are often designed to minimize power usage to extend battery life. Oftentimes, minimizing power usage affects an app that has to be running continuously. And those are the types of battles that we fight are things that we have to make sure we test as a new iOS minimizes power usage. Just does that turn us off? Does it does that stop Dexcom? And we've had, we've discovered things of that nature where it could affect our app. So there you go. Long answers. All right. Stacey Simms 14:44 No, no, that's great. And you mentioned you've asked iOS you've asked Apple to make changes. I assume the alarm was one any others that you can share. Kevin Sayer 14:52 I know that nothing I could share. Nothing major that I like you said they're very cognizant of the Dexcom community there we are. You know, we're we're a very large part of the iOS, you know, we're pretty, it's pretty vocal group when it comes to iOS, Stacey Simms 15:06 pretty vocal group period, the whole community. Alright, we say that with love. So another question came from my group, which was about Sugarmate. This is a, I would describe it as a third party app that uses the Dexcom information. And now the real time API to display and and act on data in its own way, my understanding is that Tandem owns Sugarmate, just from way of background here. And you know, Dexcom owns a little bit of Tandem. So there's a relationship there. Can you speak a little bit about data sources, but the bottom line question here was using Sugarmate and the situation to ask you, does Dexcom feel like they own the patient data? Or do the patients still own their data, even when going through the Dexcom web API's, we believe Kevin Sayer 15:49 the patient's own their data, not us, let me rephrase that we believe the patient's control the use of their data, we are the stewards of that data sitting on our servers. And so we have a responsibility to maintain it and to keep it but where that data goes and where that data is used. We do believe, particularly if it's identified data, that the patient absolutely has complete control over that there's vector sugar made, it's interesting, it was not using API's before it was a like many and non authorized use of the data to display it in a different format that people quite candidly, mess, like better than looking at the Dexcom app. And that's fine. That's why we built the live API's, we made a server change to upgrade our server platform, again, more capacity, more safety, more redundancy. It's a project that's been going on for years. And we've come to the end of that project this year. And when doing so there were some technical issues with Sugarmate, they very quickly switched over to the live API's. And now this is an authorized use of the data based on platform and data pipes that we built. So we're willing to share the data with people when they want it. I think that's an attitude of Dexcom. That changed very much over the years, when we first started, we had a hard time with that concept. Because we worked so hard to invent this technology and gather this data, why would we share it with anybody and say, See, you remember the early days and Nightscout, they were mad at us, we were mad at that. Now, we're not mad at anybody anymore. I think it's important that the data sharing be structured and be used for good purposes. But you know, all in all, it's a, it's a good use of the data that we have, because these are still Dexcom customers. If you want to, you're still buying sensors and using them. It's not a bad thing. Stacey Simms 17:35 Let me ask you a question about the sensors. And this came up in the fall. I've seen it less since but it's still out there. And I don't know if this is something you can answer. But it seems that we have not received this. But it seems that some customers are getting the G6 sensors, the inserters brand new in the original packaging, but a new label on it that says this product meets shelf-life extension requirements. I'm your people I reached out to them in the fall, they told me the stickers, oh, you know, it's all legit. There are updated expiration dates. But I'm curious why this is happening. And you know, what is the shelf life of the G6, Kevin Sayer 18:10 I can tell you exactly what's going on, you do shelf-life testing for product as selling your product will last. And over the course of our product lifecycle, you trying to extend that shelf life through more testing to make sure the product still works for the same amount of time period, if you manufactured product with 12 months shelf life, and then extend that shelf life to 18 months. And it's still the same product and still same manufacturing process rather than unbox it, put it in a new box or throw it away, we put a sticker on the outside because it's same products been tested, it's been proven that it works for 18 months, that's not a problem. That doesn't mean that it's 18 months old, we never have inventory that sits around that long to my knowledge, but we do extend shelf lives, it's important for us to do that, with respect to the distribution channel, particularly as we go to the pharmacy, you know, in the drugstore and and our distributors, the longer they have, you know that they can keep product, the better. We don't want people throwing product away if they don't have to. So all that means is we've extended our testing and shown that the product still works for a longer period of time and wanted to to label the product accordingly. That's all Stacey Simms 19:17 Yeah, I think because it came at a time when there is nervousness just in general not just in diabetes about supply chain and, you know, scarcity concerns. It just seemed unexpected, if that makes sense. Kevin Sayer 19:30 Well I one of the reasons to extend life is in fact supply chain we don't have inventory issues with G6 you know G6 is a very very well running process right now and still, you know, the premier sensor on the market. In fact, we launched a G6 derivation product in Europe, these past three months called Dexcom. One a it's a cash pay product sold on the E commerce platform in four European countries say See now and it's a lower price and geographies. But we did a feature that we took away, share and follow. We're not connecting any devices. It's it's a simpler technology. And again, we have d six supply to be able to go and do things like that. And we are planning to have G7 capacity to do similar things. We are not shooting small on either front will have capacity on both sides. And, you know, listeners on a supply chain perspective, we have been extremely diligent with respect to components for our products. And right now we see things very good today. We my operations team has just been outstanding on this front. So knock on wood, no, no Dexcom problems today. Stacey Simms 20:40 All right, two more questions for you. As always, we're going to run out of time. And as you're listening, I would refer you again, we did have a conversation about Dexcom. One in a previous show. So I will link that up. This one is more of I've asked this, you answered it, but I still continue to get questions to please ask you please make sure when GS seven comes out that Medicare is taken care of? Kevin Sayer 21:00 Well, that is a great question. And I think we've learned from our mistakes in the past. So we will when we get G7 done, what we will do is we will file with CMS to get G7 reimbursement. That's a process that I've heard anecdotally takes three to six months. So if we can get it done in three months, we can't file with CMS until it's approved. But we'll file after approval, and then we'll go and it is our plans to have capacity for all of our US users. When we go it is not that Medicare delay for G6 was one of the most emotionally gut-wrenching things I've dealt with here, because you can't imagine how many emails I got. But we didn't have capacity, and we didn't have everything ready. We've learned from our mistakes. And we'll hopefully be ready to go to everybody. That's our plan right now. Stacey Simms 21:49 That's great. Okay, and my last question is, and I hate doing this to you, but I'm doing it anyways, look into the chapter, we're gonna look, we're gonna come at it sideways, because I did have one listeners and ask him what's planned for the g8? And I said, Come on, let's let him get the G7. Oh, you know what? I'm happy? You can answer that. Let's go for it? Kevin Sayer 22:07 Well, well, I'll give you two because we did lose some time in the beginning because my computer wasn't functioning properly. As we look to the future, we want performance to continue to be better. And then we ask ourselves, but we're getting to the point where as you get to an eight, Mar D, we're getting close to finger six, I don't know how much more of a gap there's going to be, as we look to the future, and even G7 derivatives, we want to go to a longer life, we want to go to 15 days rather than 10. We'll be running studies doing that over the next couple of years. We've got a couple of plans there. We're always looking to upgrade the electronics, and how much better electronics, you know, I know one of your bigger user complaints is connectivity and loss of data, how do we improve that experience for our customers to make that better over time? Because we can always be better. And phones change faster than medical devices? So what why do we put there, we're looking at ways how we can help the environment for future product launches again, and changes in the next platforms, G6 has a lot more materials than G7 does as far as just raw plastic. So how do we make an impact there? On the cost side, there's some form factor things that are pretty far out there that we look at that I won't go into that are really, really fun. We'll see if we had done that. And if they're feasible from a cost of manufacturing perspective, but again, we're now very much focused on customer preference, rather than can't we make this work well enough, you know, in my early days here, it's Can we can we just get this thing working well enough to whereby people can rely on it. Whereas now it's one of those features that are going to make it a more engaging experience. And the last one will be software and analytics and things like that, as I look out over time, do we end up with analytics to whereby we can offer our users a menu of choices on the software side to whereby they can get more if you want Dexcom when don't want to connect or talk to anybody? You can have that if you want something that literally literally analyzes every glucose measurement that you take and does something scientifically. How do you get there, I think there's a number of experiences we can develop over time for future product generations without changing the form factor. So I don't see any slowdown in investment on the r&d side. And on the product side, G6 is the best product out there now and G7 will just be better in every way. And then we just keep going from there. Stacey Simms 24:27 And I appreciate you answering that. Thank you. So if you keep going from there, this is the sideways kind of question I wanted to ask. Okay, go ahead. Okay. A couple of days ago, Abbott announced the idea of what they're calling Lingo, which is bio wearables that will track not only glucose, but ketones and lactate and alcohol. And they say these are not medical devices. You know, this is for people who want to be you know, ultra-marathoners and things like that. We're already seeing sensors used in that way right now. Any plans to do something like this? Kevin Sayer 24:56 You know what our electronics platform for G7 We could put any, if we could develop a sensor wire with membranes and analytes and such for to measure something else, it would fit right into G7. And we design G7. With that in mind, we have advanced technology work going on with the other analytes. But it's still an advanced technology phase, we have to answer a couple of questions. First, have we done all we're supposed to do on the glucose side? Before we run there, and we got a lot to do right now, Stacy, you've heard me talk on this call. And so we need to get done what we started, we need to get G7 launched, we need to scale it up and manufacture it in the 10s. And ultimately, hundreds of millions of products as we stand up a factory in Malaysia and get our Arizona facility built out even more. So we've got to get that work done. The second piece, I'm going to answer this in three pieces. The second piece is what is the commercial opportunity for each of those things. They did announce this line of sensors, but they're all individual sensors. So I've worn a lactate sensor, I'll be completely honest with you from the lab and seeing what it does to my workouts and it's very cool, I can see which workout is better than another one. But I'm not ultra-marathoner, I probably wouldn't change my life. But it was very interesting to look at. There are other scientific uses of black data, particularly in a hospital setting. But what is the market for those, and so we're gonna kind of take an approach, we'll continue to develop the science and if Abbott wants to go develop a market, I am happy to follow this time rather than create it, like we've done with glucose. The third piece of this is there are a lot of biosensors out there. Now, you have your Apple Watch, and Apple is continuing to gather more and more data or ranks, whoop bands, Fitbits, they're advertised on television all the time, I would love to incorporate data from these other sensing technologies into into Dexcom. And vice versa, share our data with those people, particularly as you head down the health and wellness path. And let's get some other people's sensors into our platform. In all honesty, if Abbott's really good at sensing these other things, we'll take that data on our platform and analyze it to if they want to, I guarantee you, that probably isn't gonna, gonna happen. But we would, you know, let's be open about this. We're going to get our glucose work done to because we've not seen an opportunity that exceeds this. Stacey Simms 27:13 Got it? Excellent. Well, thank you so much for answering that it really is so interesting to watch and to see if, as you say, if any of this really, really makes a difference commercially, if people do want to adopt it widely. You know, I think the jury's still out, so we shall follow. Kevin Sayer 27:26 Hey, thanks for having me again. Stacey Simms 27:27 Thank you so much. Have a great day. You're listening to Diabetes Connections with Stacey Simms. More information at the episode homepage, diabetes, Dash connections.com. I'll have the transcription up as soon as I can. But again, quick turnaround on this episode. Thank you so much, again, for sending in the questions. Obviously, I didn't get to all of them. And if you're not in the Facebook group, that's generally where I asked for questions for this kind of thing. It's Diabetes Connections of the group. I'll link it up in the show notes. As always, I know not everybody's on Facebook, please feel free to always email me if you email me now about Dexcom. I'll save those questions until the next time we talk to them. It's Stacey at diabetes connections.com. Again, it's in the show notes and it's on the website. But I get it not everybody is on Facebook these days. To that point, at the very beginning of the show, in that little sponsor tease before things even begin, I mentioned club 1921. So let me tell you a little bit more might be an update for some of you. Maybe some of you are hearing about this for the very first time. Briefly, club 1921 is a website. It's a project I've been working on for a long time. And it is a place where anyone with any type of diabetes can find events anywhere in the United States. We are in beta right now. I invite you to go to the website club 1920 one.com. Until around, check it out. Let me know what you think we've immediately identified we went into beta, late last fall several things mostly about the signup that need to be fixed, those could be fixed by the time you log in, my guess is closer to the end of January. There's a little bit of confusion there. I'll explain in a moment. But other than that, it's pretty well set. The idea here is that instead of a Google Calendar or something like that, this would be a website where you go, you sign up, you tell us what kind of events you're looking for, and then you never have to come back, we'll email you automatically. When events that meet your criteria are edit, very easy. So you pick your type of diabetes, you pick your location, you pick which type of events you want, you pick your age, I mean, you can just say I want everything in every category you can kind of go through, but whatever you pick, and you can change those if you want to come back and change your filters, but whatever you pick, we will email you when those events are added. If you want to add events. There are two types of events you can add one we're very creatively calling events. This is your JDRF walk. This is your friends for life conference. This is your hospital education for people with type two. It's an event by an organization a was a staff an event where they expect lots of people or it's regularly scheduled, or there's a fee, that kind of thing. The other kind of events we're calling Hangouts. These are my favorite types of events. I love what we're calling Hangouts. This is your mom, coffee, your kid play date at a playground, you know, you're going out to a bar, post COVID, with your adult friends with type one, hang outs are not put on by an established organization. They're put on by people like you and me, we don't have a staff, we just want to meet people in our area. When you're adding those. That's where a lot of the confusion came up in the registration process. Because if you want to add events or Hangouts, you actually have to sign up in a different way. So I'm going to talk more about that as the weeks go on. We're fixing that part of the website. But if you try to sign up and you see some confusion, it may be because you are trying to add an event or a Hangout. If you want to just sign up to learn about the events and Hangouts, it should be pretty simple. But if it's not, if you have any questions, any suggestions, please let me know. Email me Stacey at diabetes connections.com. Pretty soon you'll email me Stacey at Club 1920 one.com You're going to be hearing a lot more about this because I'm so excited about it. Yes, I know, we might not have a lot of events this year, that's fine. We're going to have events, eventually, in the diabetes space. Again, we're gonna have lots of events, and social media, Facebook, even things like Eventbrite are a terrible way to get the word out about them. And it shouldn't be work to find them, you should be able to just raise your hand and say, I want to know about this stuff. And it should automatically come to you. And that's what I'm hoping to do here. Okay, back to our regular schedule with the podcast. We will have our Wednesday in the news that's live at 430. Eastern on Wednesday on YouTube and Facebook, and then 445 on Instagram. And then that turns into an audio podcast episode for Fridays. And hopefully next week, we're back to Tuesday and Friday. And we won't do any of this nonsense of pushing episodes around. But I do appreciate your patience. Again, I didn't want you to wait a week for this interview. All right, thank you as always to my editor, the very flexible and understanding John Bukenas from audio editing solutions. And thank you so much for listening. I'm Stacey Simms. I'll see you back here in just a couple of days until then, be kind to yourself. Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News.. Tandem & Omnipod updates, T1D kids & COVID and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Nov 12, 2021 6:06


It's "In the News..." the only diabetes newscast. This week we find out about: SGLT2 inhibitors, more evidence this T2D med works for T1D, Tandem & Insulet earning calls: what you need to know, Which kids with T1D did even better during COVID? How you sleep could increase risk of gestational diabetes, what's going on for Diabetes Awareness Month and lots more! Have 5 minutes? Give it a listen! -- Join us LIVE every Wednesday at 4:30pm EDT Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode transcription below:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. As always, I'm going to link up my sources in the Facebook comments – where we are live – we are also Live on YouTube and in the show notes at d-c dot com when this airs as a podcast.. XX In the News is brought to you by The World's Worst Diabetes Mom, Real life stories of raising a child with diabetes. Available in paperback, on Kindle or as an audio book – all at Amazon.com -- XX Our top story, evidence that SGLT-2 inhibitors can help kidney and heart health in people with type 1. These are diabetes drugs that are already shown to lower blood sugar levels – they have brand names like Invokana and Jardiance – but they are not approved for T1D in the United States. The problem is that they can lead to DKA even with normal glucose levels. However, they are approved in Europe and many advocates say they can be used safely if people no to monitor closely. https://www.news-medical.net/news/20211107/Study-examines-benefits-of-SGLT2-inhibitors-in-individuals-with-type-1-diabetes.aspx XX Some tidbits in Tandem's third quarter investment call last week. CEO John Sheridan says they plan to ask the US FDA this year to approve Control IQ down to age 2 – right now it's only approved to age six. Also asking for expanded labeling for people with type 2. Mobile bolus or bolus by phone still out there waiting for approval – Sheridan says the FDA last asked them any questions in August. He says they have three initiatives for 2022: filing for the Tsport pump, integrating the upcoming Dexcom G7 and moving ahead with their partnership with Abbott's Libre. Sheridan thinks it'll be a matter of a few months before Tandem pumps integrate the G7 saying, “When it comes to Dexcom, we've integrated three generations of their sensors already. We're on the fourth. We know how to do this” I hadn't heard this, but Sheridan says the Libre had a bit of a hiccup with the FDA approving it as an iCGM, that's a newer designation… because taking vitamin C can throw the readings off.. but he believes they've addressed that. We'll follow up. https://www.fool.com/earnings/call-transcripts/2021/11/03/tandem-diabetes-care-inc-tndm-q3-2021-earnings-cal/ XX Insulet also had their quarterly call – CEO Shacey Petrovic says she's still optimistic about Omnipod 5 being approved this year.. she says they've had a lot of back and forth with the FDA in the last few months and that's what makes her more confident. Other tidbits.. Omnipod reports that 80% of their customers were previously on multiple daily injections only .. no prior pump experience. They think when Omnipod 5 comes out there will be more competitive switchers from other pumps. They reiterated that it will be a limited release when approval comes with a gradual rollout in the US. https://www.fool.com/earnings/call-transcripts/2021/11/04/insulet-corporation-podd-q3-2021-earnings-call-tra/ XX Really interesting news about some children in the US with type 1 during the pandemic – they had more time in range and lower A1Cs during the first year of the pandemic compared to the year before.  They also saw their doctors more, even though 90-percents of the visits were virtual. This was a group of kids ages 1-17 all of whom use a CGM. The researchers say they want to take a closer look to try to figure out why this was the case: speculation ranges from more oversight from parents to flexibility in schedules. I can say this definitely happened in my house.. however I'll also throw in that my son started on his first hybrid closed loop system in Jan 2020 just before the pandemic– Tandem's CIQ - and that made a huge difference, especially when we were stuck at home and he was eating at 2am. They don't mention the insulin delivery system here.. just that every kid had a CGM. https://www.healio.com/news/endocrinology/20211108/metrics-improve-for-us-children-with-type-1-diabetes-using-cgm-in-first-year-of-covid19 XX Something called sleep-disordered breathing may play a role in gestational diabetes and insulin resistance. There isn't a lot of research here.. This study looked at women who had risk factors for obstructive sleep apnea, a form of sleep disordered breathing that has been linked with high blood pressure, heart disease, and Alzheimers. The data suggests those with it may enter pregnancy at higher risk for gestational diabetes and recommend more screening. They added further investigation is needed to see if treating the breathing issue in early pregnancy could improve glucose levels. https://www.contemporaryobgyn.net/view/women-with-sleep-disordered-breathing-linked-to-insulin-resistance-and-gestational-diabetes-risk XX Fun story in football this week: Mark Andrews and Blake Ferguson will face each other in the big Thursday night NFL game. Andrews is with the Baltimore Ravens, Ferguson plays for the Miami Dolphins. They both live with type 1.  It's thought this is the first time two NFL players with T1D have faced each other. They each use Tandem pumps, btw, so expect to see some posts from that company promoting the game. XX Big grant for Beyond Type 1's DKA Awareness Campaign. The Helmsley Charitable Trust is giving them more than $300-thousand dollars for their grassroots messaging movement. This provides posters to schools and communities and sends literature to pediatricians. Almost 50%  patients under the age of 18 in the U.S. are in DKA when diagnosed with Type 1. https://beyondtype1.org/beyond-type-1-receives-300985-helmsley-charitable-trust-grant-for-dka-awareness-campaign/ XX Lots of good stuff happening for Diabetes Awareness Month.. Dexcom is partnering with Nick Jonas and Patti LaBelle… they say to help the diabetes community feel seen and heard, while  advocating for improved access to diabetes care. Nick Jonas has been sharing people living with diabetes on Instagram and that's been really fun to see. Patti LaBelle lives with type 2.  She spoke to Congress earlier this month to talk about better access for people with Type 2 diabetes, especially in communities of color. XX Great round up of this kind of stuff – what the big organizations are doing for Diabetes Awareness Month over at Diabetes Mine.. I'll link that up in the show notes; https://www.healthline.com/diabetesmine/diabetes-awareness-month-2021#dexcom XX quick reminder that the podcast this week is our first ever tech roundtable. Really great discussion with two guys who follow this stuff very closely – Kamil Armacki better known as Nerdabetic and Chris Wilson. We go through everything in front of the USA FDA, some stuff that's approved in Europe and talk about what's coming next. you can listen to wherever you get your podcasts or if you're listening to this as on a podcast app, just go back an episode. Next week: holiday help – ask the Dmoms is back to help you through what can be a stressful time of year. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

Diabetes Connections with Stacey Simms Type 1 Diabetes
"Amplify the Value of CGM" - Dexcom's Jake Leach talks about Garmin, the G7 and Dexcom One

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Oct 26, 2021 36:38


With Dexcom announcing a big new agreement with Garmin this month, it seemed like a good time to check in on a few issues. Stacey talks with Dexcom's Chief Technology Officer Jake Leach about Garmin, the upcoming Dexcom G7 and Dexcom One. She asks your questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring. Just a reminder - the Dexcom G7 has not yet been submitted to the US FDA and is not available for use as of this episode's release. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Previous episodes with Jake Leach: https://diabetes-connections.com/?s=leach Previous episodes with CEO Kevin Sayer: https://diabetes-connections.com/?s=sayer Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode transcription below:   Stacey Simms  0:00 Diabetes Connections is brought to you by Dario Health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.   Announcer  0:20 This is Diabetes Connections with Stacey Simms.   Stacey Simms  0:26 This week Dexcom announced a big new agreement with Garmin this month seemed like a good time to check in on a few issues, including what happens to the watches and insulin pump systems that work with G6, when Dexcom G7 it's the market.   Jake Leach  0:41 We're already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running, they're moving as quickly as possible.   Stacey Simms  0:49 That's Chief Technology Officer Jake leach who reminds us that the G7 has not yet been submitted to the US FDA. He answers lots of questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Welcome to another week of the show are we so glad to have you here I am the host Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. You know, my son Benny was diagnosed with type one right before he turned to my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting. And that is how you get the podcast. And when I saw the news about Garmin, and Dexcom. I knew you'd have some questions. And I thought this would be a good chance to talk about some of the more technical issues that we're all thinking about around Dexcom. These days. I should note that since I did this interview with CTO Jake Leach on October 19. And that's exactly one week before this episode is being released that Dexcom released some new features for its follow app. I did cover that in my in the news segment. That was this past week, you'd find the link in the show notes. And as I see it for that news that release in the update, the big news there is that now there is a widget or quick glance on the followers home screen, it depends on your device, you know, Apple or Android, there's no tech support, right from the follow up, and a way to check the status of the servers as well. And I think that last one should really be an opt in push notification. If the servers are down, you should tell me right, I shouldn't have to wonder are the servers down and then go look, but that is the update for now. And again that came out after this interview. So I will have to ask those questions next time. And the usual disclaimer Dexcom, as you've already heard, is a sponsor of the show, but they only pay for the commercial you will hear later on not for any of the content you hear outside of the ad. I love having them as a sponsor, because I love that Vinnie uses the product. I mean, we've used Dexcom since he was nine years old. But that doesn't mean I don't have questions for them. And I do give them credit for coming on and answering them. Not everybody does that. I should also add that this interview is a video interview, we recorded the zoom on screen stuff. You can see that at our YouTube channel. I'll link that up in the show notes if you would rather watch and there always will be a transcript these days in the show notes so lots of options for however it suits you best. I'm here to serve let me know if there's a better way for me to get this show to you. But right now we've got video audio and transcript. Alright Jake leach in just a moment. But first Diabetes Connections is brought to you by Dario health and you know one of the things that makes diabetes management difficult for us that really annoys me and Benny, it's not really the big picture stuff. It's all the little tasks that add up. Are you sick of running out of strips do you need some direction or encouragement going forward with your diabetes management? Would visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that in more you don't the wavelength the pharmacy you're not searching online for answers. You don't have to wonder about how you're doing with your blood sugar levels, find out more, go to my dario.com forward slash diabetes dash connections. Jake leach Chief Technology Officer for Dexcom thanks so much for joining me. How are you doing?   Jake Leach  4:22 I'm doing great, Stacey. It's a pleasure to be here.   Stacey Simms  4:24 We really appreciate it. And we are doing this on video as well as audio recording as well. So if we refer to seeing things, I don't think we're sharing screens or showing product. But of course we'll let everybody know if there's anything that you need to watch or share photos of. But let me just jump in and start with the latest news which was all about Garmin. Can you share a little bit about the partnership with Garmin? What this means what people can see what's different?   Jake Leach  4:49 Yeah, certainly so I'm really excited to launch the partnership with Garmin. So last week we released functionality on the Dexcom side and Garmin released their products, the ability to have real time CGM readings displayed on a whole multitude of Garmin devices by computers, and a whole host of their watches. So they've got a lot of different types of watches for, you know, athletics and different things. And so you can now get real time CGM displayed on that on that watch. So they're the first partner to take advantage of some new technology that we got FDA approved earlier in the year, which is our real time cloud API. So that's a a way for companies like Garmin to develop a product that can connect up to users data through the Dexcom, secure cloud and have real time data, we've had the capability to do that with retrospective data that three hour delayed, many partners are taking advantage of that. But we just got the real time system approved. And so Garmins, the first launch with it.   Stacey Simms  5:50 Let me back up for just a second for those who may use these devices, but aren't as technologically focused. What is an API? When you got approval for that earlier in the summer for real time API? What does that what does that mean? Yeah, so   Jake Leach  6:03 it's a API is an application programming interface. And so what it really means is, it's a way for software applications, like a mobile app on your phone, to connect via the Internet to our cloud with very secure authentication, and pull your CGM data in real time from from our cloud. And so it's basically a toolkit that we provide to developers of software to be able to link their application to the Dexcom application, and really on the user side, to take advantage of that feature, you basically enter in your Dexcom credentials, your Dexcom username and password. And that is how we securely authenticate. And that's how you're basically giving access to say, for example, Garmin, to pull the data and put it down onto your devices. What other   Stacey Simms  6:51 apps or companies are in the pipeline for this. Can you share in addition to Garmin? I think I had seen Livongo Are there others?   Jake Leach  6:58 Yeah, so Livongo so Tela doc would purchase the Lubanga technology, they've got a system. They're also in the pipeline for pulling in real time CGM data into their application. And so they're all about remote care. And so trying to connect people with physicians through, you know, technology, and so having real time CGM readings in that type of environment is a really nice use case for them. And so and for the for the customers. And so that's, that's where they're headed with it. And we've got kind of a bunch more partners that are in discussions in development that we haven't announced yet. But we're really see this, the cloud API's are interfaces as a way to expand the ecosystem around a Dexcom CGM. So we really like to provide our users with choice. So how do you want your data displayed? Where do you want it? And so if you want to right place, right time for myself, have a Garmin bike computer so I can see CGM readings right on my handlebars, I don't have to, you know, look down on a watch or even thought phones, it's really convenient. That's what we're about is providing an opportunity for others to amplify the value of CGM.   Stacey Simms  8:06 This was a question that I got from the listener. What happens to the data? Is that a decision up to a company like Garmin, or is that part of your agreement, you know, where everybody's always worried about data privacy? And with good reason?   Jake Leach  8:19 Yeah, data privacy is super important area when when you're handling customer information. And so the way that it works is, when you're using our applications at the beginning, when you sign up, there's some consents, you're basically saying this is what can be done with my data. And the way we design our systems is, for example, with the connection to the Garmin devices, the only way they can access your data is if you type in your credentials into there, it's like it's almost like typing your username and password into the web to be able to access your bank account. It's the same thing, you're granting access to your data. And each company has their own consents around data. And so we all are required by regulatory agencies to stay compliant with all the different rules to Dexcom. We take it very seriously, and are very transparent about what happens with the data that's in we keep it in all of our consent forms that you click into as you as you work through the app.   Stacey Simms  9:13 But to be clear to use the API or to get the Dexcom numbers on your garmin, you said earlier, you have to enter your credentials,   Jake Leach  9:19 you have to you have to enter your Dexcom username and password. And that's how we know that it's okay for us to share that information with Garmins system because you are the one who authorized it.   Stacey Simms  9:30 Right. But that's also how you were going to use it. You just said you have to enter your name and password for them to use the information. So they just have to read individually like okay, Garmin or Livongo or whomever. Yes. Your individual terms of services.   Jake Leach  9:42 Yeah, for each each application that that you want to use you it's important to read the what they do with the data and how to use it.   Stacey Simms  9:49 That's really interesting. And Has anything changed with Dexcom? It's been a long time since we've talked about how you all use the data. My understanding is that it was blinded, you know, you're not turning around over to health insurers and saying yeah, done on this day this or are you?   Jake Leach  10:03 No, no, not at all, we basically use the information to track our product performance. So we look at products there. So it's de identified, we don't know whose product it was, we just can tell how products are performing in the field. That's a really important aspect. But we also use it to improve our products. So we when we see the issues that are occurring with the use of the product, we use it to improve it. So that's, that's our main focus. And the most important thing we do with it is provided to users where, where and when they need it. So you know, follow remote monitoring that the reason we built our data infrastructure was to provide users with features like follow and the clarity app and so forth.   Stacey Simms  10:36 Do those features work on other systems? Can I use Garmin to share or follow?   Jake Leach  10:41 Not today? So right now, it's, it's basically intended for the the person who's wearing the CGM. It's your personal CGM credentials that you type in to link the Carmen account. And so for today, it's specific around the user.   Stacey Simms  10:57 I assume that means you're working on for tomorrow.   Jake Leach  10:59 There's lots of Yeah, lots.   Stacey Simms  11:02 Which leads us of course to Well, I don't have to worry about that right now. Because you can't use any of this without the phone and the Phone is how we could share it follow. So it's not really an issue yet. Jake, talk to me about direct to watch to any of these watches. Yeah, where do we stand? I know G6. It's not going to happen. Where are we with G7? Right back to Jake answering my question, you knew I was gonna bring that up. But first Diabetes Connections is brought to you by Gvoke Hypopen. And when you have diabetes and use insulin, low blood sugar can happen when you don't expect it. That's why most of us carry fast acting sugar and in the case of very low blood sugar, why we carry emergency glucagon, there's a new option called Gvoke Hypopen the first auto injector to treat very low blood sugar Gvoke Hypopen is pre mixed and ready to go with no visible needle. In usability studies. 99% of people were able to give Gvoke correctly find out more go to diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com/risk now back to Dexcom's jake leach answering my question about direct to watch   Jake Leach  12:19 That's a great question and a really exciting technology. So direct to watch is where through Bluetooth, the CGM wearable communicates directly to a display device like a watch. So today, G6 communicates to the phone and to insulin pumps in our receiver are the displays. With G7, what we've done is we've re architected the Bluetooth interface to be able to also in addition to communicating with an insulin pump or a receiver and your mobile phone, it can also communicate with a wearable device like a Apple Watch, in particular, but other watches have those capabilities, with G7, reducing the capability within the hardware to have the direct communication director watch. And then in a subsequent release, soon after the launch to commercial launches of G7, we'll have a release where we bring the director watch functionality to the customers, there's the Bluetooth aspect, which is really important, you got to make sure it doesn't impact battery life and other things. But there's also the aspect of when it is direct to watch, it becomes your primary display. And so being able to reliably receive alerts on the watch was something that initially in the architecture wasn't possible. But as Apple's come out with multiple versions of the OS for the watch, they've introduced capability for us, so that we can ensure you get your alerts when you're wearing the watch. And so that was a really important aspect for us. And it's also for the FDA to ensure that if that's your main display, you've walked away from your phone, you have no other device to alert you that it's going to be reliable. And so that's exciting progress of last couple years with Apple making sure that can happen. You know,   Stacey Simms  13:56 we're all excited for Direct to watch. Obviously, it's a feature that many people are really clamoring for. But you guys promised it first with the G five in 2017. Do you all kind of regret putting the cart before the horse that way? Because my next follow up question is why should we believe you now?   Jake Leach  14:15 Yeah, you know, it Stacy's a good question. So we are hand was kind of forced because Apple actually announced it before we did. So they basically said we're opening up this capability on the watch to have the direct Bluetooth connectivity. And of course, we were excited to have someone like Apple talking about CGM on that kind of a stage. But then as we got into the details of actually making it work, we, you know, continually ran into another technical challenge after another technical challenge, and I totally agree. I wish it would have been two years later that they talked about at the keynote, but I'm comfortable that we've gotten past those types of issues. And so and it is built into G7. So we've got working systems and so it will introduce it rather quickly with G7   Stacey Simms  14:56 and to confirm G7 has been submitted for the CE mark Because the approval in Europe, but has not yet, as you and I are speaking today has not yet been submitted for FDA approval in the US.   Jake Leach  15:06 Yeah, we're just we're just finishing up our submission, we get some validations that we're running on some of the new manufacturing lines to make sure we can build enough of these for all the customers, we want to focus to move over to G7 as quick as possible. And so we'll we'll submit you seven to the FDA before the end of this year,   Stacey Simms  15:22 just kind of building off what you mentioned about Apple and making these announcements or, you know, sometimes Apple lets news get out there. Because they I don't know if they seem to enjoy it. I'm speculating. I don't have any insight track at Apple. But I wanted to ask you, I don't know if you can say anything about this. For the last year, every time I talk to somebody who's not getting the diabetes community, but they're on a technology podcast, or they're, they're hearing things about non invasive blood glucose monitoring, right, the Apple, Apple series seven or some watch this year, we're supposed to have this incredible, non invasive glucose monitoring was gonna put Dexcom and libre out of business, it was gonna be amazing. Of course, it didn't happen. But a bunch of companies are working on this. And Apple seems to be really happy to say maybe, or we're working on it, too, is Dexcom listening to these things. I mean, obviously, they're not here yet. They they are going to come. I'm curious if this is all you kind of happy to let that lay out their speculation. Or if you guys are thinking about anything like this in the future,   Jake Leach  16:17 we pay a lot of attention to non invasive technologies. We have a an investment component of our company that looks at you know, early stage startups. We also have many partnership discussions around CGM technologies. And so when it comes to non invasive, I think we'd all love to have non invasive sensors that are accurate and reliable. You know, for many, many years since I've been working on CGM, and many years before that, there has been attempts to make a non invasive technologies work. The challenge, though, is it's just sensing glucose in the human body with a non invasive technology is not been proven feasible. It's just there's a lot of different attempts and technologies have tried, and we pay close attention. Because if if something started to show promise, we become very interested in it. And basically making a Dexcom product that uses it, we just haven't seen anything that is accurate and reliable enough for what our customers need. That's to say, there could be a use case where a non invasive sensor doesn't have to be as accurate and reliable as what what Dexcom does. And so maybe there's a product there. But we're very focused on ensuring that the accurate, the numbers that we show, the glucose readings that we present to users are highly accurate, highly reliable, that you can trust them. And so when it comes to non invasive, we just haven't seen a technology that can do that. But I know that there's lots of folks out there working on it. And we're, we stay very close to the community.   Stacey Simms  17:40 Yeah, one of the examples I gave a guy who doesn't he does an Apple technology podcast, and he was like, you know, what, what do you think? And I said, Well, here's an example. He would a scale, and you have no idea if it's accurate. But you know, that once you step on it that that number probably is is stable, then you know, okay, I gained 10 pounds, I lost 10 pounds. But I have no idea if that beginning number makes any sense at all, you might be able to use that if you are a pre diabetic, or if you're worried about blood glucose, but you could never dose insulin using it because you have no idea where you're starting. So I think that's I mean, my lay person speculation. I think that's where that technology is now and to that point, but other people outside the diabetes community are looking to one of the more interesting stories, I think, in the last year or two has been use of CGM and flash glucose monitoring for people without diabetes at all, for athletes, for people who are super excited and interested in seeing what their body's doing. So we have companies like levels and super sapient. And you know, that kind of thing using the Liebreich. I'm curious of a couple of parts of this question. If you think you want to answer it is Dexcom. Considering any of those partnerships with the G7, which is much more simple, right? fewer parts and that kind of thing.   Jake Leach  18:46 Yeah, that's a great point, Stacey. So yes, G7 is a lot simpler. It was designed to be to take the CGM experience to the next level. And part of that is just the ease of use the product deployment the simplicity, someone who's never seen a CGM before, we want to be able to walk up approach G7 And just use it. There's a lot of opportunity we feel for glucose sensing outside of diabetes. Today CGM are indicated for use in diabetes, but in the future, with 30% of the adult population in the US having pre diabetes, meaning the glucose levels are elevated, but not to the point where they've been diagnosed with diabetes. There's just so much opportunity to help people understand their blood sugar and how it impacts lifestyle choices impact their blood sugar. In the immediate feedback you get from a CGM is just a there's nothing else like it. And so I think, you know, pre diabetes and even as you mentioned, kind of in athletics. There's a lot of research going on right now in endurance athletes, and in weight loss around using CGM readings for those different aspects. So I think there's a lot opportunity we're today we're focused on diabetes, both type one and type two and really getting technology to people around the globe. That can benefit from it. That's where our focus is. But we very much have programs where we look at, okay, where else could we use CGM? It's such a powerful tool, you could think in the hospital, there's so much opportunity around around glucose. Alright, so I'm   Stacey Simms  20:13 gonna give you my idea that I've given to the levels people, and they liked it, but then they dropped off the face of the earth. So I'll be contacting them again. Here's my idea. If somebody wants to pay for a CGM, and they don't have diabetes, but they're like paying out of pocket because they like their sleep tracker, and they like this and they like that, or some big companies gonna buy it and give it away for weight loss or whatever. You know, the the shoe company toms, where you buy a pair of shoes and they give one away. People are in the diabetes community are scrimping and saving and doing everything they can to get a CGM. Maybe we could do a program like that. Where if you don't quote unquote medically need a CGM. Your purchase could also help purchase one for an underserved clinic that serves people with diabetes.   Jake Leach  20:54 Getting CGM to those folks that didn't need them, particularly underserved areas, clinics. It's so important. I like the idea. It's a that's if there was a cache component that then provided the CGM to those that are less fortunate. I think that's, I like the idea. Next month is National Diabetes Awareness Month. And one of the things we're focused on for the month of November is how can we bring broader access to CGM? It's something we've been working on, you know, since we had our first commercial product, and there's still, you know, many people in the United States benefit, you know, 99% of in private insurance covers the product. You know, a lot of our customers don't pay anything, they have no copay. But you know, that's not the case for everybody. And so there's, there's definitely areas that we need to we are focusing on some of our non profit partners on bringing that type of greater access to CGM, because it's such a powerful tool and helping you live a more normal life.   Stacey Simms  21:50 In the couple of minutes that we have left. I had a couple more questions, mostly about G7. But you mentioned your hospital use. And last year, I remember talking to CEO Kevin Sayer about Dex comes new hospital program, which I believe launched during COVID. Do you have any kind of update on that or how it's been going?   Jake Leach  22:06 Yeah, so it was a authorization that we got from the FDA to raise special case during COVID, to be able to use G6 in the hospital. And so we had quite a few hospitals contact us early on in COVID, saying, Hey, we've got these patients, many of them have diabetes, they're on steroids. They're in the hospital, and we're trying to manage their glucose. And we're having a hard time because their standard of care in hospitals is either labs or finger sticks. And so we got this authorization with the FDA, we ship the product, many hospitals acquired it, and they were using it pretty successfully. What we'd say about G6 is really designed for personal use your mobile phone or a little receiver device, designed integrated with a hospital patient monitoring system or anything like that. You could imagine in the future that that could be a real strong benefit for CGM, the hospital, you can imagine you put it on, you know, anybody who has glucose control issues comes in the door. And then you basically can help ensure where resources need to be directed based on you know, glucose risk. I've always been passionate about CGM at a hospital. It's one of the early projects I worked on here. Dexcom. And I think it there's a lot of promise, particularly as we've improved the technology. So there's still hospitals today using G 600 of the authorization. And we're interested in designing a product for that market specifically, instead of right now. It's kind of under emergency years. But we think there's there's a great need there. That CGM could could help in basically glucose control in the hospital.   Stacey Simms  23:28 That's interesting, too. Of course, my mind being a mom went to camp as well. Right? If you could have a bunch of people I envision like a screen or you know, hospital monitoring that kind of thing. You wonder if you could do something at camp where there's 100 kids, you know, instead of having their individual phones or receivers at camp, it would be somewhere Central?   Jake Leach  23:46 Well, you know, what, between with the with the real time API, there are folks that are thinking about a camp monitoring system that can basically be deployed on campuses right now with follow. It's great for a family, but it's not really designed to, to follow a whole camp full of campers. But with the real time API, there's opportunities for others to develop an application that could be used like that. So yeah, there you go.   Stacey Simms  24:08 All right, a couple of G7 questions. The one I got mostly from listeners was how soon and I know, timelines can be tricky. But how soon will devices that use the G6? Will they be able to integrate the G7 Insulin pumps, that sort of thing? Sure. It's only Tandem right now. But you know, Omnipod, soon that that kind of thing?   Jake Leach  24:26 Yeah, I mean, that's coming. So I'll start with the digital partners like Garmin and others, that is going to be seamless, because the infrastructure that G6 utilizes to move data to through the API's is the same with G7. So that'll be seamless. When you talk about insulin pumps, so those are the ones that are directly connected to our transmitters that are taking the glucose readings for automated insulin delivery. So those systems were already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running so they're moving as quickly as possible. So once We have G7 approved, then they can go in and go through their regulatory cycle to get G7 approved for us with their AI D algorithms. Really the timing is dictated mainly by those partners and the FDA, but we're doing everything we can to support them to ensure this as quick as possible.   Stacey Simms  25:17 Take I should have asked at the beginning, I'm so sorry, do you live with type one I've completely forgotten.   Jake Leach  25:21 I don't I made a reference to where I wear them all the time. Because, as you know, kind of leading the r&d team here, I love to experience the products and understand what our users what their experience is. And I just love learning about my glucose readings in the different activities I do. So I don't have type one. But I just I use the products all the time.   Stacey Simms  25:42 So to that end, have you worn the G7? And I guess I'd love to know a little bit more about ease of use. It looks like it's, it just looks like it's so simple.   Jake Leach  25:51 It is. Yeah. So I've participated in a couple of clinical trials where we use G7, it is really simple. One of the most exciting things though, I have to say is that when you put it on, it has this 30 minute warmup. So the two hours that we've all been used to for so many years, by the time you put the device on and you have it paired your phone, it's there's like 24 minutes left before you're getting CGM. So it's like it's it. That part is just one of the things that you it sounds awesome. But then when you actually experience it, it's pretty amazing. But yeah, the ease of use is great, because it's the applicator is simple. It's a push button like G sex where you just press the button and it deploys. But there's other steps where you're not having to remove adhesive liners, the packaging is very, very small. So we really focused on low environmental footprint. And so it's really straightforward. But probably the most the really significant simplification the application process is because the transmitter and the sensor all one component and sterilized and saying altogether, there's no pieces, there's no assembly required, you basically take the device and apply it and then it's up and running. There's no transmitted a snap in or two pieces to assemble before you you do the insertion.   Stacey Simms  26:59 I think I know the answer to this. But I wanted to ask anyway, was it when you applied for the CE mark? And I assume this would be the same for the FDA? Are there alternate locations? In other words, can we use it on our arms?   Jake Leach  27:11 And yeah, that is that is a great question. Yeah, our focus with one of our phones with G7 and the revised form factor, the new new smaller form factor and sensor probe was arm were so yeah, arm wears is really important part of the G7 product.   Stacey Simms  27:26 I got a question about Dexcom. One, which seems to be a less expensive product with fewer features that's available in Europe. Is that what Dexcom? One is?   Jake Leach  27:34 Yeah, so there's a product that we recently launched in Europe in European countries. That is it's called Dexcom. One. And what it is, is it's it's a product that's designed for a broad segment of diabetes, type one, type two, it's a lower price point. It has a reduced feature set from G6. But what it's really about is simplicity. And so in you know it's a available through E commerce solutions. So it's really easy to acquire the product and start using it. It's really to get into certain markets where we either weren't didn't have access to certain customers. And so it's really designed for get generating access for large groups of people that didn't have access to CGM before.   Stacey Simms  28:20 What does e commerce solution mean? No doctor   Jake Leach  28:23 there. So outside the United States CGM isn't no prescription required for many, many countries. So the US is one of the countries that does require prescriptions, other some other countries do too. But there's a large group outside the US that don't, but it's really around, you can basically go to the website, and you can purchase it over a website. So really kind of nice solution around think Amazon, right. You're going you're clicking on add the sensors and you're purchasing it. It's a exciting new product for us that we are happy to continue developing.   Stacey Simms  28:53 I think it might come to the US don't know. Yeah, that's   Jake Leach  28:56 good. Good question. Don't don't know. I mean, I think right now we see CGM coverage is so great access is great for CGM in the US it can always be better and extend your focus on that. But it's really for countries where there wasn't access,   Stacey Simms  29:08 I would think tough to since we do need a prescription differently. Yeah, Jake, you have been with Dexcom, almost 20 years, 18 years now. And a lot has changed. When you're looking back. And looking forward here at Dexcom. I don't really expect you to come up with some words of wisdom off the top of your head. But it's got to be pretty interesting to see the changes that the technology has brought to the diabetes community and how I don't know it just seems from where I sit and you're probably a couple of years ahead. It seems that the last five years have just been lightspeed. It has   Jake Leach  29:39 been things are speeding up in terms of our ability to bring products to market and there's a lot of things one is the development of technology. The other component is working with your groups like the FDA on you know, how do we get products to the customers as fast as possible and that that's been a big part of it right moving cheese six to class to becoming an IC GM that That was a huge part of our ability to get the technology out quickly and also scale it. I think there's a lot of aspects that has been faster. And you know, when I started Dexcom, we had this goal of designing a CGM that was reliable didn't require finger sticks that could make treatment decisions. All that and we were 100% focused on that. And as we got closer and closer, and now we have that which you six and also what you seven, then the opportunity that that product can provide, you start to really understand how impactful CGM can be around the world. And that's what I'm excited about now is I'm still excited about the technology always will be and we still have lots to do on making it better, more reliable and more integrated. But just how much CGM can do around around the globe. There's just so many things. It's beyond diabetes to so very excited about the future.   Stacey Simms  30:47 Many thanks, as always, and we'll talk soon, I am sure but I mean, I could never get to say it enough. I can't imagine doing the teenage years with my son without Dexcom. You guys, I know you did it just for me. You did it just in time. Appreciate it very much. He is doing amazing. And I can't he would not be sticking his fingers 10 times a day. So thank you.   Jake Leach  31:05 That's great to hear. Thanks, Stacy.   Announcer  31:12 You're listening to Diabetes Connections with Stacey Simms.   Stacey Simms  31:18 As always more information at diabetes connections.com. And yeah, but that last bit there, I can say nice things. I mean, I really do feel that way. And I can still ask not so nice questions. Like if you're new, quite often, I will open up a thread in our Facebook group. It's Diabetes Connections of the group to gather questions for our guests. And I did that here with Dexcom, there's usually quite a lot of questions, I do have to apologize, I missed a big one. Because of the timing of the interview, I promise I will circle back around next time I talk to Dexcom. And that is all about the updates for iOS and for new phones, and how you know, sometimes Dexcom is behind the updates. What I mean by that is that they lag behind the updates. So you can go to the Dexcom website, I'll put a link up for this for Dexcom products that are compatible in terms of which iOS and that kind of thing. And they are behind. And Dexcom will always say they've said very publicly that they are working hard to catch up. But I guess the question that a few people really wanted to know was why, you know, why do they lag behind? What can be done about that? So they know, but I think it would be a good question to ask. So Sarah and others. I appreciate you sending that question. And I apologize that I didn't get to it this time around. And I'll tell you, you know, it's not something we've experienced, but I think it has to do and I'm speculating here more with the phone with the the newness and the the model of the phone sometimes then for the updates, especially if you don't have your updates on automatic. So I guess I'm kind of saying the same thing. But what I mean by that is Vinny, and I have very old phones. I have an eight. I'm not even sure he has the eight. We are terrible parents and I don't care about my phone, I would still have a Blackberry if that were possible. So I can't commiserate. I'm so embarrassed to even tell you that I can commiserate with the updates, because it's just not something that we have done. Benny, definitely if he were here, trust me. It's like his number. I would say it's his number one complaint that it's really high up on the list of complaints to the parenting department in our house. And yes, Hanukkah is coming. His birthday is coming. There will be some new phones around here. I'm doing an upgrade. I'm sure both of us have cracked phones. Were the worst. Oh, my goodness. All right. Well, more to come in just a moment. But first Diabetes Connections is brought to you by Dexcom. And this is the ad I was talking about earlier in the interest of full disclosure. But you know, one of the most common questions I get is about helping kids become more independent. I get asked this all the time at conferences for virtual chats in my local group. These transitional times are tricky. And we've gone through this preschool to elementary elementary to middle middle to high school. I can't speak high school to college yet, but you using the Dexcom really makes a big difference. For us. It's not all about sharing follow, although that's very, very helpful. Just think about how much easier it is for a middle schooler to look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to just show their care teams a number. Here's where I am right before Jim. At one point, Ben, he was up to 10 finger sticks a day, he didn't have Dexcom until the end of fourth grade not having to do that made his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo. I don't know about you, but I am getting a ton of email already about Diabetes Awareness Month and that is November this time of year I usually get I'd say 120 emails that are not snake oil, right one in 20 emails that maybe make sense for something we want to talk about on the show here that I would share on social media and I'm just inundated with nonsense. So I hope you are not as well. But I gotta say Diabetes Awareness Month this year. I've been pulling in My local group and talking about what to do because usually I highlight a lot of people and stories and I'll I'll still do that, I think, but I got to tell you people are, um, you know, this, we're all stressed out. And while it's a wonderful thing to educate, I always think Diabetes Awareness Month is not for the diabetes community, right? We are plenty aware of diabetes, this is a chance to educate other people. And that's why I like sharing those pictures and stories on my page, because the families then can share that with their people. And it's about educating people who don't have diabetes. But gosh, I don't know this year, I'm going to be just concentrating on putting out the best shows that I can I do you have a new project I mentioned last week that we're going to be talking about in the Facebook group. By the time this airs, I will have the webinars scheduled in the Facebook group. So very excited about that. Please check it out. But what are you doing for Diabetes Awareness Month? If you've got something you'd like me to amplify, please let me know. You can email me Stacey at diabetes connections.com. Or you can direct message me on the social media outlet of your choice. We are at YouTube, Facebook, Twitter and Instagram. That's where Diabetes Connections lives. I'm on Tik Tok, or Snapchat or Pinterest. Oh my gosh. All right. Well, that will do it for this week. Thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I will be back on Wednesday. live within the news. Live on Facebook and now on YouTube as well. Until then, be kind to yourself. Benny: Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Juicebox Podcast: Type 1 Diabetes
#510 Dexcom G7 App Refresh with Dexcom CTO

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Jul 20, 2021 66:59


Jake Leach is Executive Vice President and Chief Technology Officer at Dexcom. He is here to share Dexcom updates, talk about G7 and an impending app refresh. Some cool Apple watch news too! Show notes for people who are Bold with Insulin Find out more about the Dexcom CGM Get a FREE Omnipod Demo today  Learn about Touched By Type 1 Gvoke Glucagon the only Pre-Mixed glucagon  CONTOUR NEXT ONE smart meter and CONTOUR DIABETES app Add your voice to the T1DExchange The Juicebox Podcast is a free show, but if you'd like to support my work directly, you can 'Buy me a cup of coffee' at buymeacoffee.com/juicebox - Thank you! A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadioRadio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

Diabetes Connections with Stacey Simms Type 1 Diabetes
Dexcom CEO Kevin Sayer Answers Your Questions

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jul 6, 2021 35:56


What do we know about the upcoming Dexcom G7? Find out in this conversation with company CEO Kevin Sayer. As usual we have a long list of questions from you covering everything from adhesives to watches to more. Sayer shares details about how they're preparing for the G7 rollout once it's approved, as well as issues with Medicare, integration with their current pump partners and when arms will become an approved wear site for US customers. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Dexcom G7 "sizzle reel" Get your diabetes gear to stick! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcription below   Stacey Simms  0:00 Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed autoinjector for very low blood sugar, and by Dexcom help make knowledge your superpower with the Dexcom g six continuous glucose monitoring system. This is Diabetes Connections with Stacey Simms. This week, a Dexcom update from the company's CEO. As usual, we have a long list of questions from you covering everything from adhesives to watches to more about the upcoming G7.   Kevin Sayer  0:41 And the goal is to simplify CGM for everybody across the board. What I often say is everything you love about G6, you'll love more about G7. The size is so small, you don't really recognize it's on your body. It's really a great profile a little bigger than a nickel   Stacey Simms  0:56 CEO Kevin Sayer will also share details about how they're preparing for the G7 rollout once it's approved, as well as details about Medicare and use but their pump partners. This podcast is not intended as medical advice. If you have those kinds of questions, contact your health care provider. Welcome to another week of the show, always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. I'm your host, Stacey Simms, my son Benny was diagnosed back in 2006. Just before he turned two he is now 16 and a half my husband lives with type two diabetes, I do not have diabetes, but I have a background in broadcasting. And that is how you get the podcast. My usual disclaimer, whenever we have them on Dexcom is a sponsor of this show, you will hear their commercial later on. It's because we love the products. But when we have people from Dexcom on as guests to give you information, they don't tell me what to ask or what to say outside of that commercial. And I just want to take a minute to say I very much appreciate Kevin Sayer and others from Dexcom being so accessible over the years, you know, they don't always answer my questions, but at least they come on and address them and listen to them. There are a lot of companies that are very reluctant to even do that who won't come on the show. And that's really unfortunate because you as you listen, and you know the diabetes community overall, I'm very much entitled to speak to these people and to these companies. So I will keep pushing nicely, but I'll keep pushing, I promise quick heads up there will likely be no longer format episode like this one next week. I'm still gonna do the in the news episodes that I have added live on Facebook and then turning them into podcast episodes. But I am as you listen, if you're listening as this episode is going live, I met friends for life. I'm at the conference. They're having it again. I'm so excited. It's the first diabetes conference I have attended since February. No, since the first week of March of 2020. I went to a JDRF conference in Wilmington, just as COVID was beginning it was very weird. If you did anything any kind of public event in March of 2020. You remember that? But I'm back. They're back friends for life. And I really don't want to rush out an episode. But if anything exciting or you know breaking news happens or I'm able to record something and put it out I will but just a heads up likely no episode next week. Alright, and this week, not much of an introduction needed. Kevin Sayer is the CEO of Dexcom. And this interview focuses on some of what came out of the recent Ada scientific sessions and att D conferences. But mostly I share your concerns and your questions. We've covered a lot of these issues before, I don't ask a lot of follow up about things that in my opinion, you can easily Google up as usual, I had limited time with Sarah, who was doing back to back interviews. So if you have a specific question or if things went by very quickly, definitely jump into the Facebook group. You can comment on the post with this episode. We have some amazing members who will answer your questions Who will show you where to find the information. It's likely a previous episode, but we have people in clinical trials with people who were in on a lot of the investor calls they listened they take notes, they're fantastic. So if you haven't joined Diabetes Connections, the group on Facebook I highly recommend it. my interview with Kevin stay here in just a moment but first Diabetes Connections is brought to buy Gvoke Hypopen  and you know low blood sugar feels horrible. You can get shaky or sweaty or even feel like you're gonna pass out. There are lots of symptoms and they can be different for everyone. I am so glad we have a different option to treat very low blood sugar Gvoke Hypopen is the first auto injector to treat very low blood sugar Gvoke Hypopen is pre mixed and ready to go with no visible needle. Before Gvoke people needed to go through a lot of steps to get glucagon treatments ready to be used. And this made emergency situations even more challenging and stressful. This is so much better and I'm grateful we have it on hand. Find out more go to Diabetes connections.com and click on the Gvoke logo Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon dot comm slash risk. Kevin Thank you so Much for jumping on with me another busy time for you as so many presentations, lots of studies, lots of news, lots of upcoming and anticipated news. So I appreciate you spending some time with me and my listeners. Oh, thank you for having me. It's always fun. Let's set the table a little bit here. We are following up on the ATTD conference and you are in the midst Dexcom as we're speaking of ADA, this is all still virtual though, right?   Kevin Sayer  5:25 It's all still virtual. Yeah, I was looking was hopeful earlier this year, it might be in person, but not yet, probably not till next year.   Stacey Simms  5:33 Well, as we look through the news that is coming out of both of these conferences, I could just start out by saying it's kind of I'm not sure victory lap is the right phrase here. But it does seem that almost every study is basically Kevin CGM works, it's good. It helps we get better outcomes from it. So let me just give you a moment to talk about some of that. Because there were so many we can't really touch on all those studies.   Kevin Sayer  5:58 There are so many studies, and it's good for a number of different groups as well. You've got all the automated insulin delivery studies, and other the Medtronic product all these other studies are powered by Dexcom. You've got stuff in the UK, France, Insulet Tandem in the US, there's a lot of good news on the automated insulin delivery system front. And all these works are powered by Dexcom G6 right now, you've got studies that we presented at att last week, or that were presented by physicians that were very well aware of the mobile study, which was for patients with type two diabetes who are on basal insulin only. You know, when you start a study like that, it's kind of a risk, because you asked yourself the question, what happens if it doesn't work? Well, it works. And what we learned is these patients, even though they're not making a decision every four or five, six hours, because for eating, they are making decisions about what they eat, and what they do and how they exercise when they can see data. And they can see the effects of what goes on in their lives. And their timing range goes up significantly, if they can see what their time and range is, you know, they've been operating in the dark, and people would argue that they don't need it all the time, like I do. And so that study, we think is just really good and will be the basis, hopefully someday for getting CGM coverage for that group of patients. And so we'll push on that one. There was another study we had last week, or at ATD. Early in the month, published in Belgium, where a coalition of diabetes gurus I guess over there's best icon, it's really all the leaders in the Belgian diabetes community took a bunch of intermittent CGM users and put them on Dexcom G6 for an extended period of time. And then we've looked to see what happened. And what we saw is on real time CGM, the patients are better in every category, every single category, time and range, hyper hypo, you name it, they did better. So we really did validate the Dexcom equation over competitors with that study. And we think it's very important. I realize real time CGM, it is important, it is important to data be accessible. And the alerts are something that you can use. There are other studies being presented by other people in the type two who are reading Kaiser's got a study where they show patients do well on doulas got several studies, they're across the board. And the evidence is building for these other markets. But it starts at the beginning, obviously with automated hands on delivery and, and we work our way down. But we've had information presented across the board showing the utility of Dexcom. And if you've been to this study 10 this meeting 10 years ago, like I was when I first started here, my literally my first month was my first Dexcom ada, nobody even knew who we were. And those who did said yeah, products not real great. So times have changed pretty dramatically.   Stacey Simms  8:41 Do you remember what what that first study that was presented at ADA or ATTD? which one it was that you were there for 10 years ago? I'm curious that back in the day,   Kevin Sayer  8:50 yeah. First study, we didn't even present studies. Back then we, I will tell you the most important study we did, we did a study in where we first got ADA recognition, we did a study with our G4 system against a competitor in Europe. And we got a bunch of recognition there. And then the next study that really got us a lot of recognition in Ada meeting was our diamond study where we show the people on multiple daily injections. If they went to CGM, they would get much better results. What it was hard for me to learn is you don't say I want to do a study like this and get it done in a week. It takes a couple of years to accumulate all the proper data, process it develop all the subsets and everything. And so my patience has been has been level set with respect to studies like this. And there's multiple studies going on in the field that will be present over the next several years.   Stacey Simms  9:44 All right. Well, that's a really good segue to moving ahead, because, as you know, my listeners are very interested in this technology. And the slide that probably got the most attention in our groups was one that was presented at ATTD about introducing the Dexcom G7, showing all of the features of this. So let me I'm not going to go through all of them, obviously. And you and I've talked about this many times before, but faster warm up. It's smaller, simple application all in one. This is all still part of the plan, as we had talked about before. Yes. Okay.   Kevin Sayer  10:20 Yeah. And, you know, we started working on the G7 before G6 was even in clinical trials. The G7 is a project we've envisioned for a long time, verily, actually was Google Health before then, verily was a partner with us in designing this product, and we working out for quite some time. And the goal is to simplify CGM for everybody across the board, what I often say is everything you love about G6, you'll love more about G7, the size is so small, you don't really recognize that it's on your body, it's really a great profile a little bigger than a nickel. It we're running this study with arm and abdomen indications. And while patients were in wherever they want, we're going to show you that it can be worn wherever you want. And I think that's a big deal that we go ahead and do the work to do that. The faster warmup is kind of mind blowing when you put a g7 up and then you look after you pair it. And then you look and say you only got 25 minutes left, it's like, oh, wow, I don't have to do the two hour countdown. You know the accuracy and performance that Jake presented. ATTD shows that we're not, we're not ever going to go easier on the performance side and say good enough, we always push ourselves to offer something that will keep people save and confident with what they have. The app is completely new, we'll build things into the app over time, like automated, the frequently asked questions feature we have now but we're just gonna keep making it better. Some of the features of our clarity system will ultimately be in the app. So you'll get more information. When you go to it and look at it out of the get go. You know, we'll get it approved. It'll be a while before our partners have integrated their systems. But we're working with Insulet and Tandem already on G7 integration, I it'll be able to talk to multiple devices at the same time. Its manufacturing cost, ultimately will be less expensive. It's been designed for an automated process. And we've got fully automated lines up and running to assemble the G7 sensors we have in fairness to have automated G6 lines up and running now to but we've got special transmitter lines and center lines and different those kinds of things. It is going to be a really the most advanced CGM ever   Stacey Simms  12:25 Well, you've touched on a couple of listener questions already in that testing alternate sites, including arms integration with the systems that are already using G6, so I don't want to spend a lot of time going in depth on things that you've mentioned. But in the slide it said direct to watch capability.   Right back to Kevin clarifying what was meant in that slide. But first Diabetes Connections is brought to you by Dario Health and bottom line you need a plan of action with diabetes. We've been lucky that Benny's endo has helped us with that and that he understands the plan has to change as Benny gets older, you want the kind of support to take your diabetes management to the next level with Dario. Their published Studies demonstrate high impact results for active users like improved in range percentage within three months reduction of a1cwithin three months and a 58% decrease in occurrences of severe hypoglycemic events, try Dario's diabetes success plan and make a difference in your diabetes management. Go to my daario.com forward slash diabetes dash connections for more proven results and for information about the plan. Now back to Kevin Sayer, answering my question about what the company means when it says the Dexcom g7 has director watch capability.   Kevin Sayer  13:44 capability. Yeah, it won't go there first pass. But we had to have different electronics and a different radio set to go director Watson what we have in G6. And it's easier to get us to change and is to get Apple changed or to change their watch. And so as we were doing the g7 system, we did contemplate that. So it is configured to do so I do not believe it's in the first release. But it will be not long after that. We'll have a direct watch capability. And we know people really want to watch presents interesting problems. And we can all sit and say we want that. But you have to charge your watch every day or at least every 36 hours. Where are you getting your alerts if you're direct to watch and it's on the charger. And you're in different parts of your house. There's complexity sit a watch that go far beyond just direct to connect. And particularly with the FDA who've used the alerts in the alarms. I think connectivity is so important that we had to make sure we do it right. So we'll work on that and get it wired appropriately. But I look I know what something I would want If I were a user. So I we continue to push for it.   Stacey Simms  14:44 Just to follow up on that. When you say it won't be in the first iteration of it. But you know, it'll it'll be it's capable. It'll come that it kind of implies that you figured out what to do with the alerts and alarms when someone hangs it up to charge.   Kevin Sayer  14:56 I don't know what they have figured out. I just know they're addressing it. All right. I have to plead the fifth, I just as I've asked that question, they said, Well, here's a problem. How are you going to deal with that? I said, Well, you guys don't have to tell me. They'll come up with the right answer I   Stacey Simms  15:09 So I'm sure they will, but to say direct to watch capability, there's a little parentheses that says when we figure it out, oh, wait, I know we're working on but   Kevin Sayer  15:17 okay. But Stacy, we couldn't even go direct watch before with the electronics. We couldn't go direct to watch with a G6 transmitter, the g7 electronics stack and configuration is such that it can go direct to the watch, we could not watch G6.   Stacey Simms  15:32 Okay. Many more questions. My listeners are very, of course interested in the adhesive changes is the G6, two G7 change. I know you're addressing this in your testing, we've got emails from people who are in different trials for adhesive and reactions and things like that. And I have lots of questions people say it's getting better other people say it's getting worse. Anecdotally, it's very difficult, obviously, for me to now talk to you a little bit about those changes and how it's improving.   Kevin Sayer  15:58 Well, we've tested numerous adhesives before we landed on the adhesive we we selected for g7, one of the reasons we kept the product life down to 10 days is to make sure we have enough adhesive to get to that 10 days, we'll be putting the overpass in every box. So if somebody wants an overpass, they don't have to call us. So everybody should be thrilled with that one. And it's quite easy to use, we're hopeful that there's no allergy. With G7, somebody's always gonna have a reaction does just physiology, but we're working with new tapes for G6 already, where it will hopefully have something the things that cause a lot of the allergic reaction in G6, we've eliminated from the G7 manufacturing process. So we're hopeful that a lot of this stuff goes away on its own, we'll monitor it very quickly. But we've already got four or five other g7 adhesives in test in addition to the ones that we're going to launch with, to make sure we can create better options in the future if we need to. So you know, stay tuned on that one, we are comfortable. As I sit here, we will not have the same level of reaction that would have at G6 when we change it. But yeah, we won't know till we're out there. Yeah.   Stacey Simms  17:10 And you mentioned the 10 day were and part of that being you for adhesive. But my understanding is that the idea is for 14 day wear for Dexcom. She said eventually,   Kevin Sayer  17:19 eventually, eventually not again, that first pass or get it approved with 10 day data, very important to us is that we provide our customers with the experience they paid for and they signed up for. And we've looked at competitors reliability data, how many make it out to 14 days, or how many make it seven days if they only have seven, and we look at, it's one of the key management indicators, we monitor how many of our sensors are making it out to 10 days, and we've set a pretty high bar for how we want our system to work. And while we could have lost a longer lasting product, we wouldn't have hit the percentages with the configuration that we have. And so we said, OK, 10 days is enough. Our patient base is fine with 10 days as long as we deliver on the 10 days that we promise. And we'll get into longer live trials literally as soon as we're done with these and hopefully move it over. Because that does cost us a lot less and give us more pricing flexibility over time for the various groups. But for now we'll go 10 days, mainly, so we have more reliability. That's the biggest reason.   Stacey Simms  18:22 I have a few more G7 questions, but they're about pricing and accessibility, why?   Kevin Sayer  18:26 You know what I can I can answer most, okay, because we can't really go address pricing until it's approved. Right. And we have as we put our G6 contracts in here together over the past couple of years done so in anticipation of a g7 product to whereby, for example, for Medicare, it's a fixed charge per month. And for many of our insurance contracts, it's resembling more that type of business arrangement, we're hopeful that we can transition to g7 very quickly. But we will have to go to all your payers and get G7 covered before they'll pay for it. We're hopeful that'll be a quick process. But in the meantime, G6 is a great product and people will be able to use it, I can't give you a timeframe as to how long it'll take will have to go to CMS will have to go to all the Medicaid groups as well, what we're trying to avoid. And let me repeat what I don't want to deal with is one of the things I dealt with with the G6 for a long time, we didn't have enough inventory of production capacity to get it to every group. So the Medicare population was stuck with G five for quite some times those emails were not good. We want to make sure it's equal access when we can get it in the channel for everybody. And we're trying to build that type of capacity.   Stacey Simms  19:34 A couple of what if questions, just kind of looking down the road JDRF recently announced that they are looking for and this is the very beginning. So as you listen or as you're watching, this is not in the works yet. This is a call for research that they are looking for a CGM that could also measure ketones, and I haven't seen any companies step up yet publicly to say yes, we're working on that we'd like to be part of that is that Anything that Dexcom is thinking of doing.   Kevin Sayer  20:02 We've explored this for quite some time long before the JDRF initiative. And the question I keep asking, is continuous ketone measurement important that we know that for the pediatric world that if you measure ketones continuously, you might predict dangerous decay moment before it happens. But at what cost to the system? And is there a cost benefit associated with this? So we're setting all those things? We're in the learning phases, we think we have a platform that can do that. But we've got to decide do you sacrifice glucose accuracy? If you throw a ketone sensor on there? There's a lot of answers. We don't have yet. But we're in the early phases. And we've talked with JDRF and others about it, is there a better way to measure ketones that might be easier and less expensive? I don't know. We've looked at several other analytes to go with our system over time. And I think in the future, that'll be some but that's not coming from us for at least three years, if not longer.   Stacey Simms  20:57 You've looked at other analyze satellites, tell me about what else has been looked at just for free? No.   Kevin Sayer  21:03 Well, I won't go into all of them. I certainly look at lactate from a stress level. And for physical fitness, for example, there are a lot of athletes, you'd like us to produce a lactate sensor to whereby they can measure the progress of the physical fitness. There's also used for lactate in the hospital environment with we think with respect to predicting things sepsis over time, but those are you know, that's one of them. And we've looked at a few others and fail, I won't go into all those. We've looked at some that may be promising. What we find from time to time is Yeah, what we'd love to measure but we can't is insulin on our wire. There are any way we could measure insulin in addition to glucose, wouldn't that be awesome? We know exactly how much insulin you have on board. And we know exactly Well, we can't we we've not been successful at that one that would require a different technology than what we have. So we look at all of them. And over time, we think we'll have some some good stuff there. But not for a while.   Stacey Simms  22:00 Um, you know, you mentioned hospitalizations. And last year we talked about the CGM program in hospitals. I forgive me I, there were so many studies at ADA and ATTD. I don't know if this was presented. But let me ask a general, how is it going? Are hospitals adopting and adapting to you are   Kevin Sayer  22:16 they are adopting and adapting is harder than adopting? Yeah. Because, you know, this is a device that was designed for your listeners. And for you. It wasn't designed as a device that was designed to be used in a hospital room with all of the cybersecurity and connectivity issues of a hospital. Where do we send the information? How do we get it there. And and so we've got to solve the workflow issue to make this meaningful in the hospital environment. Over time, what we have learned is our technology is more than good enough to go there. And that the places particularly where you have an endocrinologist very heavily involved in treating the diabetes patients in the hospital rather than a cardiologist or somebody else, when there's an endocrinologist involved, we can go very quickly, they can learn some of the hospitals would take an approach, let's put this on everybody. Others would only take an approach. Let's put this on severe cases. So there have been different protocols used. But by and large, the response to CGM in the hospital has been very, very good. And we think it is a great market for us over time, we got to work on the proper configuration for workflow. I mean, one of the best examples, how do you get the data to the medical record? Because everything in the hospital goes to the medical record? How do we make that seamless? We haven't figured that out yet. And that'd be important for all of our users even outside the hospital. Imagine how much easier would be to go to your doctor and have your Dexcom date already sitting in the medical record when you get there? We're not there yet. But we're having a lot of good discussions on that front.   Stacey Simms  23:42 One of the topics that's been kind of in the community recently, and I don't think it's so much Dexcom. But I want to ask you, anyway, is this issue of and you mentioned, athletes who want to measure certain things of people without diabetes, using Flash glucose monitoring, or continuous glucose monitoring? I'm curious is that a market that Dexcom is looking to pursue? I mean, the g7 is smaller, it's lighter. And you know that I'm asking this because we've talked many times before, people who use insulin, are very much afraid of not being able to afford being left behind if many, many, many people who may not use it in the same way, started adopting these products.   Kevin Sayer  24:19 Let me address that in a couple of steps. Let's talk about the use case. First. There are people a lot of people using Dexcom, who do not have diabetes as a health and wellness tool. And there are a number of apps that are being developed that require glucose information to level set your nutrition now possibly type two diabetes or pre diabetes, but there are groups and some groups with some very interesting ideas as to how to change your diet based on glucose data to make you healthier. We were used many years ago on the biggest loser with every patient that came in the door and the one of the production people I don't remember which one might have been the physician came to me and said you need Yeah, the diabetes business you can make a lot For many weight loss fall, we're not getting out of the diabetes business, that's where we are and where we stay. One of the things we've contemplated with g7 is the fact that we're going to go to more people. And we're going to go to more people than just the type one population, we plan on having capacity to build over 200 million sensors, before the end of 23 200 million sensors, you can be more than enough for the intensive insulin using community. And as far as cost will cost comes down, if we can sell that much in volume. Now,   Stacey Simms  25:30 you're in the American healthcare system. Kevin, you know, this is not a market based device, we don't, I'm more, I'm more felt like, I'm sorry,   Kevin Sayer  25:39 let me keep going. At the end of the day, as you look at what somebody pays for taking care of themselves with delivering insulin and powering insulin pump, that's a very complex task that requires a lot of customer service and support. If somebody is only losing weight, that's a different problem we're trying to solve, or if somebody is trying to titrate a type two drug, that's a different problem, I think we can find a way to make everybody happy, I don't think we're gonna disappoint anybody. And we planned this company and built this company to make sure that we have capacity to do all this, it's, you know, it is, one would look at me, I mean, we're gonna spend over a billion dollars on these factories over the next two, three years here. This is not a simple endeavor, it is a large investment. And this technology first goes to the community that we serve. Now worldwide, we have to expand worldwide, but get it to the group in the US as well. After that, we'll go the other places, but we're going to have more than enough capacity to do that. In fact, one might question if I'm insane, or we're insane to create so much capacity and the 200 million, quite candidly, the wave design the g7 lines, if we need to sample at a factory, we can do it very quickly. So this is a, this is a long term play for us. We believe this technology be beneficial to a number of people. And so if we can get if we can get all these sensors out there and all these uses, I think it'll be it'll benefit your audience while it'll detract from   Stacey Simms  27:00 I know, we're going to run out of time. I've got two more questions. You've mentioned,   Kevin Sayer  27:03 you got them all give you time for two questions. Let's finish. Alright, here's what you want.   Stacey Simms  27:09 You mentioned already, lots of different apps are being developed not all diabetes. You know, a couple years ago, Dexcom announced the availability of the API, you know, developers can get data through third party apps. I'm curious, is there anything going on maybe behind the scenes? Or are you doing anything further to kind of foster more innovation in the early stage, like the development of other companies? Or is that a thing of   Kevin Sayer  27:30 the past? No, I'll give you two things that we're doing. Number one, we have a live API use where you can have a live display of the data that's on file with the agency right now, it'll eventually get approved. So you'll be able to run the Dexcom app, did it go the cloud comes straight down to another one. I think that is a very good use of the technology. And it shows our willingness to work with others. So that is a good use. One of the other things we have coming, then we'll see where it goes. Our intended use case in the beginning was with major healthcare systems. But we have another app that we've shown pictures of it's an app inside an app. So let's say for example, you go to scripts here in San Diego, pick scripts, and scripts has their own healthcare app. And they also want to be the center of your diabetes care, particularly for type two diabetes, and they might have you wearing a sensor for something other than isn't delivering, we've developed an app that can reside inside another app, to whereby you can have your scripts experience, but you can touch an icon and you go to a Dexcom experience. And it, it's an app that resides inside the app and for security, we're able to keep others out that app inside the app concept is nothing we've done to commit to others, to give them an opportunity to use Dexcom technology in a different way. And yet preserving create their own experiences. We're very cognizant of the fact that we can't solve every problem, and there might be better experiences. And we can create. Okay, got time for one more.   Stacey Simms  28:54 All right, last question. And it's more of a request. But the question is when you can This is from a couple of listeners, when you start rolling out the g7. any consideration for including and this may be an insurance question to one extra sensor a year. So three and a month?   Kevin Sayer  29:10 What a wonderful question. And let me tell you something, we spend an inordinate amount of time analyzing sensor failure and returns and those types of things. We have run models that say if we give everybody if we just gave everybody x more sensors a year, we could avoid all the phone calls and all of the issues and all that stuff. We analyze this warranty policy all the time. And I think what you'll see with with G7 will have better tools, my hope someday just for your users, I would love to just diagnosis in the app in general, to whereby if your sensor fails, we know when we say your sensor failed, tap on this icon to get a new one. The flip side of that is we have a business to run and we can't do all free centers. So if it comes to the time if you buy 12 months for the sensors, and pay for 12 months for the center's let's make sure you get 12 months where the US If that means we ship you a free one because one failed, that's fine. But we're still, you know, we found one patient in another country, I won't say which one, they got 48 free sensors and purchased all of three, because they spent all this time. Those are the far exceptions from the rule, people will just want care. And so we are doing everything we can to come up with better policies to make it easier for you. because quite honestly, those phone calls cost us way more money. And they cause you guys frustration, we are going to make this better over time. That's a promise I can make. And let's talk about it. In a future conversation. I'll tell you some of the things we've done. All right,   Stacey Simms  30:36 well hold up for a baker's dozen one of these days. But Kevin, thank you so much. You're always very accessible and on there really do appreciate your time.   You're listening to Diabetes Connections with Stacey Simms. Lots more information at Diabetes connections.com. If you haven't seen it yet, a while back Dexcom sent me what they call a sizzle reel of their G7 what it looks like. So I'll put that video in the show notes as well. We have a YouTube channel. I don't put a lot of extra stuff there. But things like that Dexcom video, and the in the news, you can watch it if you'd prefer, I always put that on YouTube. And all these episodes are there as well, although they're mostly just the audio, but a lot of people listen, watch, they listen that way on YouTube. So that'll be linked up in the show notes. And I realized I haven't mentioned it on the show yet. But you know, this time of year getting your Dexcom or getting any gear to stick can be difficult lots of wet and sweat in the summer. And I've created a guide, seven top tips to get your diabetes gear to stick in the hot summer. Over the years, we've tried so many things. Benny has had a pump since he was two. He's had a Dexcom since he was nine. So a lot of you know trial and error. And this guide is available absolutely free. So I will put a link in the show notes. If you get the newsletter, you may have already seen it. But just in case you don't. And the show notes are always at Diabetes connections.com. Every episode has its own homepage with a transcription started that in 2020. And we are working our way back. If you're listening on a podcast app, there are shownotes there but in case you have problems with links or whatever, you can always go to the episode homepage. And as I mentioned, Diabetes Connections is brought to you by Dexcom. It is hard to remember what things were like before we started using the Dexcom I just had when he was nine, right. But he had diabetes for seven years before we started using it. And I guess I haven't really forgotten what that was like. But it's just so different. Now, when he was a toddler, we were doing something like 10 finger sticks a day. And even when he got older, we still did at least six to eight every day more when he wasn't feeling well or when something was off. But with each iteration of Dexcom we have done fewer and fewer sticks. The latest generation the Dexcom gs six eliminates finger sticks for calibration and diabetes treatment decisions. Just thinking about Benny's little worn out fingertips makes me so glad that Dexcom has helped us come so far. It's an incredible tool. And then his fingertips are healthy and smooth, which I never thought would happen when he was in preschool. If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. learn more, go to Diabetes connections.com and click on the Dexcom logo. As I mentioned at the top of the show, I am at friends for life right now as you're listening. If you're listening as this goes live on the day that it goes out there, I'm traveling to friends for life, and I'll be here for the week. If you're not familiar. This is the largest family diabetes conference in the country. It takes place every July in beautiful Orlando, it's so hot, but it's a great time it's on the Disney World property. I don't usually go to the parks if my kids aren't coming. They they're not coming with me this year. So I doubt I will be going into a Disney park. But it's a fabulous conference. And I just want to let you know I'm doing a new presentation. I'm working up some new stuff. I'm very excited about it. And this one is called reframe your diabetes parent brain. And I gotta tell you, I am really sick and tired of seeing people berate themselves and talk about mom fail and tell themselves how terrible they are as parents. So this is going to be a session where we talk about the mistakes we've made. But then I want to help people reframe them so that they see what they've learned. You know, my whole philosophy is you mess up and you learn. And that's what this is all about. So I'm really excited to try it out. We're like overwhelmed. I don't know. You know, I think so many diabetes parents are so wrapped up in perfect now that they feel like if they go above 120 or 150 that they failed their children. So, gosh, I feel really passionate about it. And we're going to try that. And then for the fall, I've been getting a lot of questions about sending kids to camp, and I've gotten more and more of these over the years. You know, how do I send my type one kid to regular sleepaway camp. So I'm working on a presentation about that because fall, August, September is when a lot of people sign their kids up for next summer. So as you listen if you were affiliated with a group that does meetups or zoom calls, or in person And conferences, let me know I would love to speak to you and start these dialogues and help you really help your kids thrive with type one. We're not done. We're far from done right, Benny 16. But you know, he's a confident and happy kid. So knock wood. Where's all my wood to knock? I say all the superstitious stuff, right? I mean, I don't kid you know how superstitious I am. But I really hope that I can help other parents. You know, the idea here is not that you don't worry. The idea here is that you do it anyway. All right. Thank you so much for joining me. Thank you, as always to my editor John Bukenas from audio editing solutions. I will see you back here in a couple days for the in the news episode, but again, no long format episode, the following. Alright, I'm Stacey Simms until then, be kind to yourself.   Benny  35:49 Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

Juicebox Podcast: Type 1 Diabetes
#498 Dexcom Talk With CEO Kevin Sayer

Juicebox Podcast: Type 1 Diabetes

Play Episode Listen Later Jun 28, 2021 41:16


Dexcom CEO Kevin Sayer is here to share where Dexcom is at and answer your questions. We'll chat about Dexcom G7, Apple Watch, Adhesive and more. Show notes for people who are Bold with Insulin Find out more about the Dexcom CGM Get a FREE Omnipod Demo today  Learn about Touched By Type 1 Gvoke Glucagon the only Pre-Mixed glucagon  CONTOUR NEXT ONE smart meter and CONTOUR DIABETES app Add your voice to the T1DExchange The Juicebox Podcast is a free show, but if you'd like to support my work directly, you can 'Buy me a cup of coffee' at buymeacoffee.com/juicebox - Thank you! A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadioRadio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.

android apple watches amazon music adhesives dexcom dexcom g7 kevin sayer dexcom ceo kevin sayer gvoke glucagon
Diabetes Connections with Stacey Simms Type 1 Diabetes
In the News... Apple drops a BG hint, Dexcom G7 update, Omnipod 5 study and more!

Diabetes Connections with Stacey Simms Type 1 Diabetes

Play Episode Listen Later Jun 11, 2021 8:07


It's "In the News..." the only LIVE diabetes newscast! Top stories this week: -Apple drops a BG hint in the latest watch update -New info about Dexcom's G7 -Omnipod 5 study released -Diabetes drug shows promise for weight loss -Power of peer support Join Stacey live each Wednesday at 4:30pm EDT at https://www.facebook.com/diabetesconnections Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcription below:    Hello and welcome to Diabetes Connections In the News! I'm so glad you're here! I'm Stacey Simms and each week I'll share the top diabetes stories and headlines of the past seven days.  Whether you're joining me live on Facebook or watching or listening after, I'm here to get you up to speed quickly on what's happening with diabetes technology, research, and our community. Since these are headlines and summaries, as always, you'll find all the sources and links in the Facebook comments and in the show notes at d-c dot com. XX In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff” XX here's what's In The News this week… Couple of buzzy slides from Apple's World Wide Developer's Conference. First, this one from their WatchOS 8 update.. they didn't use the words blood glucose.. but this slide was shown featuring the graphic “blood glucose highlights.” That likely means pulling the data from existing apps like Dexcom or Dario or One Drop, but there are always rumors about Apple releasing a glucose sensor of their own.  We shall see – thanks to Nerdabetic for bringing this to our attention. Another diabetes shout out in this slide - same presentation - about time sensitive notifications. If you look closely you can see the Happy Bob app, which puts funny messages along with glucose notifications. XX Lots of news out of the recent Advanced Technology and Treatments in Diabetes Conference or ATTD. Dexcom showed this slide about their upcoming G7.  We've reported on this a lot over the last two years, I'll link up our previous episodes. but the new info includes: a 30 minute warm up time as opposed to 2 hours right now, and direct to watch capability. Direct to watch from Dexcom – that means you don't need your phone to see your BG on the watch face anymore - was first announced in June of 2017 with the G5 and that proved more difficult to implement than expected. I'm talking to Dexcom for the podcast later this month so we'll get a update on what this really means. The G7 is a smaller, all in one with sensor and transmitter applied together. It's NOT FDA approved yet so there's no timeline for release. Also, Dexcom put out a study that says people with type 2 who use basal insulin benefit from the use of CGM. The Mobile study took place over eight months. Those who used the CGM increase time in range and showed a full point drop in A1Cs on average. https://twitter.com/ATTDconf/status/1401200753717432328 New data presented on Omnipod 5.. this is just an abstract – full study will be released later this month. This is Insulet's hybrid closed loop system where it works with the Dexcom to keep a user within a targeted blood sugar range. They looked at children and adults ages 6-70 to measure safety of this new system. A1Cs came down, time in range went up, very low occurrence of hypoglycemia and researchers concluded it was safe. The Omnipod 5 operates in two modes, an automated mode and a manual mode. The system provides automatic insulin delivery with customizable glucose targets from 110 to 150, which can be adjusted by time of day. Omnipod 5 with Horizon is in front of the FDA right now so there's no timeline on release.   https://care.diabetesjournals.org/content/early/2021/05/21/dc21-0172   Also at ATTD - DarioHealth looking at outcomes from their highly personalized apps and system. Dario's study found that personalizing the clinical interventions in response to unique individual actions really helps. That's opposed to systems with more generalized predictions. This study showed more frequency in blood sugar testing and monitoring in those who received an personalized intervention. https://www.prnewswire.com/il/news-releases/dariohealth-releases-study-demonstrating-the-impact-of-personalized-digital-interventions-to-improve-self-management-of-diabetes-301305650.html XX Early on here but a new closed loop system that knows when you're eating is being tested – this was a small trial in adolescents and young adults. This is out of UVA – the same place that developed what became Tandem's Control IQ. The researchers say teenagers are particularly prone to skipping meal boluses. This system, known right now as Rocket AP contains an Artificial intelligence bolus priming system that uses CGM to basically decide if you've eaten without bolusing. If it thinks you have, it will automatically dose. The median time in range after a bolused meal was 100% with the Rocket AP system and 93% with the control system, but was a corresponding 83% versus 53% after a meal without a bolus. Again, that's 83% time in range when you completely forget your meal bolus. Bears watching. https://www.medwirenews.com/diabetes/ai-fully-closed-loop-insulin-delivery-type-1-diabetes/19231866 XX Up next.. a diabetes drug is approved for weight loss but first.. quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Inside the Breakthrough is a podcast that mixes historical wisdom with modern insight – it's a science show that's also entertaining. I love it. The latest episode talks about scientists who knew they were onto something but needed to see things with their own eyes. How actually seeing something like a Kraken? Makes a huge difference. It also meant a name change for what some thought had only been a myth. And this actually relates to diabetes! Listen to Inside the Breakthrough wherever you listen to podcasts.. Back to the news…   The FDA has approved the medication Wegovy (wee-GOH-vee), a higher dose of the diabetes drug semaglutide (semuh-GLU-tide), to be used as a weight management drug in patients with obesity. It's the first drug for chronic weight management that has been approved by the FDA since 2014. It is injected under the skin once a week. People in the study lost an average of 12 percent of their body weight. People with type 2 diabetes lost 6 percent of their body weight. No reason given for the difference and there are some – intestinal side effects – but Wegovy is said to be safer than older weight loss drugs. https://www.healthline.com/health-news/fda-approves-popular-diabetes-medication-for-use-as-weight-loss-drug   XX The power of peer support was shown at ATTD in a presentation by Kelly Close and Diatribe. Their survey showed engagement in the diabetes online community didn't just make people feel better emotionally, which is great, but it also predicted better glycemic outcomes.. those most involved in the community increased their chance of having an A1C under 7. That's Diabetes Connections – In the News.  If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com. Please join me wherever you get podcasts for our next episode -Tuesday – we're talking to the folks from Beta Bionics for the first time in a long time to get an update on the iLet pump. And the episode that's out right now is all about what college students want you to know. Thanks and I'll see you soon