Podcasts about Bigfoot Biomedical

In this episode, hosts discuss a pair of topics making headlines in recent weeks: the US Food and Drug Administration's 510(k) clearance for the Accu-Chek Solo micropump system and Abbott's acquisition of Bigfoot Biomedical.

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Abbott acquires Bigfoot, a new study looks at low-dose aspirin to prevent type 2, researchers look into whether the AI ChatGPT can answer FAQs about diabetes, Beyond Type Run is back for the NYC Marathon, and more! Our previous episode with Bigfoot Biomedical: https://diabetes-connections.com/?s=bigfoot Join us for Moms' Night Out! (use promo code School30 to save) Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Learn about Edgepark 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 Edgepark simplify your diabetes journey with Edgepark XX Our top story this week – Abbott scoops up Bigfoot Biomedical. The deal is expected to close later this year – no financial terms yet disclosed. Abbott and Bigfoot have worked together since 2017 on a connected insulin pen system. Bigfoot Unity exclusively works with Abbott's FreeStyle Libre® Long time listeners will recall that Bigfoot was founded in 2015 around serving people with type 1 diabetes with a closed loop pump system that Byran Mazlish had developed for his wife and son. Mazlish was very secretive at first about the algorithm – this was before people were sure the FDA wouldn't crack down on them – so a journalist nicknamed him Bigfoot. Along the way, the company pivoted to CGM connected SmartPens. I believe Bigfoot was my third interview, back in 2015 – I'll ink up all of the interviews I've done with them in the show notes. https://diabetes-connections.com/?s=bigfoot https://www.prnewswire.com/news-releases/abbott-to-acquire-bigfoot-biomedical-furthering-efforts-to-develop-personalized-connected-solutions-for-people-with-diabetes-301918254.html XX Low-dose aspirin reduces the risk for type 2 diabetes among older adults and slows the increase in fasting glucose levels over time, new research finds. The data come from a secondary analysis of ASPREE, a double-blind, placebo-controlled trial of healthy adults aged 65 years or older, showing that 100 mg of aspirin taken daily for about 5 years did not provide a cardiovascular benefit but did significantly raise the risk for bleeding. It's a big study, more than 16-thousand people. This new analysis shows that individuals taking aspirin had a 15% lower risk for developing type 2 diabetes and that the medication slowed the rate of increase in fasting plasma glucose, compared with placebo, during follow-up. However, lead author Sophia Zoungas, MBBS, PhD, head of the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia, says, "Major prescribing guidelines now recommend older adults take daily aspirin only when there is a medical reason to do so, such as after a heart attack… Although these new findings are of interest, they do not change the clinical advice about aspirin use in older people at this time." https://www.medscape.com/viewarticle/996058 XX A class-action lawsuit filed against Medtronic (NYSE: MDT)+ alleges that the company's insulin delivery devices shared patient data with third parties. The lawsuit — filed by the plaintiff “A.H.” in U.S. District Court in Central California — levels allegations against Medtronic and its MiniMed and InPen devices. It addresses MiniMed's transmission and disclosure of personally identifiable information and protected health information to Google and other third parties. Per the lawsuit, the data was transmitted via tracking and authentication technology, including Google Analytics, Crashlytics, Firebase Authentication and related tools. A.H. says these technologies, installed on the website and/or mobile applications, include the InPen iOS and Android applications. “Information about a person's health is among the most confidential and sensitive information in society, and its mishandling can have serious consequences, including embarrassment, discrimination, and denial of insurance coverage,” the lawsuit reads. A Medtronic spokesperson issued the following statement via email: We have strong processes, technologies, and people in place to safeguard and protect our information and systems, the information of our business partners, and most importantly, the privacy and safety of the patients and healthcare providers that use our products.” https://www.massdevice.com/lawsuit-patient-data-sharing-medtronic-diabetes/ XX Interesting new way to look at type 2 – not weight loss or medication, but about reducing how much blood glucose goes up and stays up after eating and drinking. University of Virginia Daniel Cox says this is called Glucose Everyday Matters, or GEM – aims to prevent blood sugar spikes via educated food and drink selection. This is coupled with physical activity to hasten recovery when blood-sugar spikes do occur. So someone might indulge in a piece of fruit or a small, sweet treat, knowing how it will affect them, and then go for an evening stroll to help even out their blood sugar. Sounds really simple, but in its first study, it helps almost 70-percent of people put their type 2 into remission without weight loss or medication. The National Institutes of Health has provided $3.5 million for a large-scale clinical trial Cox himself went from an A1C of 10.3 at the time of diagnoses to reading consistently under 6.0 for the past 13 years on no medication using his approach. https://newsroom.uvahealth.com/2023/08/31/radical-new-approach-to-managing-type-2-diabetes-receives-3-5-million/ XX Final preparations are in place to initiate the first clinical site for DIAGNODE-3 in the United States, and additional sites are expected to be initiated over the coming months. Approximately 10-12 clinical sites across the US are planned to be initiated, expanding the DIAGNODE-3 trial in the US and eight European countries to approximately 60 clincal sites in total. DIAGNODE-3 is designed to confirm the efficacy and safety of the antigen-specific immunotherapy Diamyd® in patients aged 12 to 29 years recently diagnosed with type 1 diabetes and carrying the genetic HLA DR3-DQ2 marker. Approximately 40% of all screened patients carry the genetic HLA DR3-DQ2 haplotype. This proportion aligns well with expectations based on previous Diamyd® clinical trials and published epidemiological research. Supported by published retrospective analyses and prospective clinical trials, the presence of the genetic HLA DR3-DQ2 haplotype determines the likelihood of responding to Diamyd® therapy, and serves as one of the main inclusion criteria in the DIAGNODE-3 trial. "Patient recruitment is a complex and central element in any trial and it is encouraging to see a significant and continuous uptick in the screening rate and that the observed frequency of the genetically defined responder group enrolled into DIAGNODE-3 confirms our previous observations", says Ulf Hannelius, President & CEO of Diamyd Medical. "This shows the operational and clinical feasibility of our precision medicine approach to Type 1 Diabetes and we look forward to expanding the trial to the United States". https://finance.yahoo.com/news/registrational-phase-iii-trial-type-142600082.html XX A low-carbohydrate diet during pregnancy may have some benefits in gestational diabetes, but overall, low-carbohydrate diets are not associated with any significant differences in outcomes. That was the conclusion of a presentation at the ADA Scientific Sessions. That was back in June but I just learned about it, so I'm passing along to you in case you missed it as well. During a debate at the American Diabetes Association Scientific Sessions, Amy M. Valent, DO, MCR, associate professor in the division of maternal-fetal medicine in the department of obstetrics and gynecology at Oregon Health & Science University, said identifying Teri L. Hernandez, PhD, RN, associate dean of research and scholarship in the College of Nursing and professor in the department of medicine and the division of endocrinology, metabolism and diabetes at the University of Colorado Anschutz Medical Campus, agreed that the first line of therapy with gestational diabetes is nutrition. However, Hernandez said, low-carbohydrate diets are not the only approach in gestational diabetes treatment with nutrition. Currently, dietary advice for treating gestational diabetes is inconsistent, and current professional guidelines have limitations and biases, according to Valent. Different diet strategies include low-carbohydrate, low glycemic index and total energy restriction eating plans, according to Valent. Valent said ACOG guidelines recommended a low-carbohydrate diet for gestational diabetes until the most recently revised edition in January. Valent reviewed several major landmark studies demonstrating that gestational diabetes treatment can decrease pregnancy complications such as preeclampsia and large for gestational age infants. “These studies were in the era where treatment of diabetes in pregnancy involved recommending a low-carbohydrate diet,” Valent said. “The concern with lowering carbohydrates is the risk of consuming lower nutrient-dense foods and resulting in the body to produce ketones, which may be associated with negative effects on the developing baby.” “Pregnancy is dynamic. Nobody's the same today as they were yesterday. They're going to be different 1, 2 or 3 weeks from now, and the nutritional demands and the fetal growth and development stage are going to be different,” Valent said. “So, nutritional demands are going to vary.” Hernandez also added that women and girls tend to be priced out of good nutritional patterns, which is an issue not only in the pregnancy field, but also in the global community. According to Hernandez, it is important to create ways moving forward to identify what nutritional patterns are best that are also affordable for families, especially in lower-income settings. https://www.healio.com/news/womens-health-ob-gyn/20230905/experts-debate-benefits-of-lowcarb-diets-for-gestational-diabetes XX XX Commercial – Edgepark XX Can ChatGPT help answer questions about diabetes? In a recent study published in the journal PLoS ONE, researchers tested chatGPT, a language model geared for discussion, to investigate whether it could answer frequently asked diabetes questions. In the present study, researchers evaluated ChatGPT's expertise in diabetes, especially the capacity to answer commonly requested questions related to diabetes in a similar manner as humans. The 'Frequently Asked Questions' section of the Diabetes Association of Denmark's website, viewed on 10 January 2023, included eight questions. The researchers designed the remaining questions to correlate to particular lines on the 'Knowledge Center for Diabetes website and a report on physical activity and diabetes mellitus type 1. Across the 10 questions, the proportion of correct responses ranged from 38% to 74%. Participants correctly identified ChatGPT-generated replies 60% of the time, which was over the non-inferiority threshold. Males and females had 64% and 58% chances of accurately recognizing the artificial intelligence-generated response, respectively. Individuals who had past contact with diabetes patients had a 61% chance of precisely answering the questions, compared to 57% for those who had no prior contact with diabetes patients. In contrast to the initial premise, participants could discern between ChatGPT-generated and human-written replies better than tossing a fair coin. While ChatGPT demonstrated some potential for accurately answering frequently asked questions, issues around misinformation and the lack of nuanced, personalized advice were evident. As large language models increasingly intersect with healthcare, rigorous studies are essential to evaluate their safety, efficacy, and ethical considerations in patient care, emphasizing the need for robust regulatory frameworks and continuous oversight. https://www.news-medical.net/news/20230905/Can-ChatGPT-be-a-diabetes-consultant-Study-probes-the-potential-and-pitfalls.aspx XX SAN MATEO, Calif., Aug. 24, 2023 /PRNewswire/ -- On November 5, diabetes nonprofit Beyond Type 1 will join more than 550 official charity partners and philanthropists raising awareness and funds while participating in the world's largest marathon, the TCS New York City Marathon. This year, the organization is expanding its 50-person team, Beyond Type Run, to include people living with type 1 or type 2 diabetes, as well as caregivers to those living with diabetes. "Since 2017, we've featured more than 200 runners on our teams who've exemplified what it means to survive and thrive with diabetes," said Beyond Type 1 CEO Deborah Dugan. Beyond Type 1 announces the 2023 NYC Marathon team to raise awareness and funds for people living with diabetes As a part of the Beyond Type Run team, runners will be advocating to raise awareness and funds for Beyond Type 1's portfolio of educational resources, awareness campaigns and peer-to-peer support programs for people impacted by diabetes. This advocacy is elevated through the NYRR Official Charity Partner Program, which offers opportunities for nonprofit organizations to raise funds to support their missions and services. Dexcom and Tandem Diabetes Care are presenting sponsors of Beyond Type Run for a fourth consecutive year. The TCS New York City Marathon Official Charity Partner Program has raised more than $440 million for more than 1,000 nonprofit organizations since its establishment in 2006. https://www.prnewswire.com/news-releases/team-of-50-individuals-impacted-by-diabetes-prepare-for-the-2023-tcs-new-york-city-marathon-301909163.html XX MNO update On the podcast next week.. tandem diabetes celebrity panel from friends for life – Hollywood, the NFL and NASCAR. Last week's episode was Benny off to college That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon. ----  

Admetsys this week won FDA breakthrough designation for its automated glucose control technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the glucose control system does and what executives are saying. Moximed has implanted its first Misha knee implantable shock absorber in the U.S. Find out what an implantable shock absorber is and what doctors think about it.  GE HealthCare and Mass General are collaborating on AI algorithms to predict missed care opportunities, expanding on its existing 10-year partnership. Whooley explains the aim of the collaboration and what the artificial intelligence algorithms will be used for.  Zimmer Biomet announced several executive appointments just days after former CEO Bryan Hanson left. Tune in to discover who joins the executive team and what the new CEO says about the shuffling.  Another diabetes acquisition is in the news – this time, Abbott is acquiring Bigfoot Biomedical. The acquisition follows an established partnership between the companies. Whooley explains their prior partnership and other acquisition news in the diabetes sector. Check out the show notes for links to the stories we discussed at MassDevice.com/podcast.

Teleflex's voluntary recall of its Rüsch endotracheal tubes highlights the possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation. Fast Five hosts Sean Whooley and Danielle Kirsh share what issue caused the recall and how many complaints the company has received so far. The FDA's IDE approval of Metavention's renal denervation therapy represents an important milestone in the treatment of hypertension. Whooley details what the platform does, how it works and how optimistic executives are. Real-world data validating the efficacy and usability of Bigfoot Biomedical's diabetes management platform underscores its potential to revolutionize diabetes care. Kirsh and Whooley discuss some of the key data points from the study and the company's future plans. Insulet's ongoing efforts to integrate its Omnipod 5 system with Abbott's FreeStyle Libre 2 sensor marks a significant advancement in the company's diabetes management technology. Whooley talks about where the technology is currently integrated and plans for a clinical study in the future. The appointment of Lea Daniels Knight as CFO of Integra Lifesciences brings a seasoned financial leader to the company's executive team. Hear about her prior experience in finance and medtech and what the company's CEO has to say. Check out the show notes for links to the stories we discussed and more at MassDevice.com/podcast.

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: learning more about Lilly's plan to lower the price of some insulins, Abbott's Libre 2 and Libre 3 get FDA approval to work with automated insulin delivery systems like Control IQ and Omnipod 5, Medicare expands coverage of CGMs for people with type 2, an old blood pressure medication shows promising results in a T1D study, and more!   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 Athletic Greens XX Insulin prices https://www.statnews.com/2023/03/06/eli-lilly-insulin-medicaid-rebates/ Drugmaker Eli Lilly & Co. on Wednesday said it will cut prices of its most commonly prescribed insulins by 70% and cap monthly out-of-pocket costs at $35 at certain retail pharmacies for people who have private insurance.   Lilly will list its Lispro injection at $25 a vial effective May 1 and slash the price of its Humalog and Humlin injections by 70% starting in the fourth quarter.   The announcement comes amid growing federal pressure to lower the cost of insulin. The Inflation Reduction Act capped insulin prices for Medicare beneficiaries at $35 per month but did not protect people with private insurance or who don't have coverage from higher prices. Eli Lilly would've had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn't dramatically cut the list prices for some of its older products this week. The company was about to run into a Medicaid penalty for raising the price of it's drugs faster than the rate of inflation. https://www.cnbc.com/2023/03/01/lilly-cuts-insulin-prices-70percent-cap-prices-at-35-per-month-for-private-insurance.html XX The FDA has cleared Abbott's Freestyle Libre 2 and Libre 3 continuous glucose monitors (CGM) for integration with automated insulin delivery (AID) systems. These devices have also been cleared for younger children, extended wear time, and for use during pregnancy.   The FDA on March 6 cleared Abbott's Freestyle Libre 2 and Freestyle Libre 3 CGM for use with automated insulin delivery (AID) systems.   AID systems connect a CGM, insulin pump, and smartphone to automatically adjust insulin dosing in real-time in response to changing glucose levels. These systems have been demonstrated to help many people with diabetes improve their time in range and reduce the time spent thinking about managing glucose each day.   With this new clearance from the FDA, Libre 2 and 3 CGMs and the connected smartphone app will soon integrate with insulin pumps to adjust insulin dosing.   Freestyle Libre 2 and Libre 3 CGMs were previously cleared for use by people with diabetes ages 4 and older. Freestyle Libre 3, cleared in the United States in May 2022, is compatible with both iOS and Android smartphones. Among several upgrades made from Libre 2, Libre 3 no longer requires users to manually scan their device with their smartphone to see glucose levels – data is sent to the mobile app automatically.   In the announcement, Abbott said the device has also been cleared for an extended wear time of 15 days, for use by children as young as age 2, and for use during pregnancy by women with type 1, type 2, or gestational diabetes.   Current users of Libre CGMs should note that the devices available now cover people with diabetes ages 4 and older, can be worn for 14 days, and are not cleared for use during pregnancy. According to Abbott, the modified Libre 2 and 3 sensors will be available in the U.S. later this year. https://diatribe.org/fda-clears-freestyle-libre-2-and-3-use-automated-insulin-delivery XX Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services.   The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note.   Dexcom and Abbott Laboratories had expected coverage to start in mid-year.   In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people with non-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.   “At first glance, it seems that the finalized CMS language is broader and no longer includes daily insulin language,” Marcus wrote.   The policy change could open up a bigger opportunity for broader coverage by commercial insurers over the next year or two, he added. Currently, just 25% of people with Type 2 diabetes who are intensive insulin users (taking multiple shots per day) use a CGM. Covering people who take basal (daily) insulin could double the U.S. market opportunity of about 2 million people with Type 1 diabetes and 2 million people with Type 2 diabetes who are intensive insulin users, a group currently covered by CMS, Marcus wrote. https://www.medtechdive.com/news/Medicare-CGM-coverage-Dexcom-abbott-ABT-DXCM/644019/ XX Bigfoot Biomedical receives FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts.   Last month Bigfoot sold its closed-loop automated insulin delivery (AID) system technology to Insulet. CEO Jeffrey Brewer said he has confidence in the makers of the omnipod to utilize Bigfoot's “great asset” in its focus on simplicity and ease of use for pump users. He said the limited rollout generated “great data” to support Bigfoot Unity in the type 2 population. That includes ease of use, especially for people who might not be tech-savvy.   The big focus for Bigfoot Biomedical, Brewer explained, remains the pharmacy channel. He said the company is currently in discussions with Express Scripts, Optum and CVS to utilize their wide reach. Brewer said that getting an agreement with one or more of those companies will enable a more broad launch this year. By wrapping the insulin delivery around CGM, Bigfoot Biomedical believes it can address the type 2 market in a new way.   https://www.massdevice.com/bigfoot-biomedical-next-steps-diabetes-management/ XX Although the use of diabetes technology has increased across all racial and ethnic groups, inequities persist, according to research published in the Journal of Endocrinology & Metabolism. In the United States, race and ethnicity have been associated with inequities in diabetes treatment and outcomes. Non-Hispanic Black and Hispanic indi- viduals with type 1 diabetes (T1D) have higher hemoglobin A1c (HbA1c), higher rates of severe hypoglycemia and dia- betic ketoacidosis, and are more likely to visit emergency departments and hospitals than individuals with T1D who identify as non-Hispanic White.   Researchers used a version of Optum's deidentified Clinformatics Data Mart to select Medicare Advantage beneficiaries with T1D between January 1, 2017, and December 31, 2020.   Investigators found that overall, use of an insulin pump, a CGM, both insulin pump and CGM, and either insulin pump or CGM increased during the 4-year study period When evaluating the data by racial and ethnic group, investigators found that the prevalence of each outcome did increase; however, “within each annual cohort and outcome, there were significant differences between racial/ethnic groups,” with gaps in prevalence between White individuals and individuals of other races and ethnicities remaining “generally increase[ing] or remaining stable” between 2017 and 2020.   When evaluating data from the 2020 cohort, there were significant differ- ences noted in the use of insulin pump and/or CGM technology based on demographic and socioeconomic factors.   According to the researchers, the “persistent inequities” in diabetes technology access found in the current study have implications “not only for patients and providers, but also for health care systems and policymakers” and require multiple policy changes to improve equitable access.     https://www.drugtopics.com/view/racial-ethnic-inequities-persist-in-diabetes-care XX The CLVer study tested whether improved blood glucose control using a hybrid closed loop insulin pump (also known as an automated insulin delivery or AID system) and/or verapamil preserves beta cell function one year after diagnosis.. The trial showed that verapamil, but not better blood glucose control, improved beta cell function over the year-long study.   In October, the FDA approved the drug Tzeild (teplizumab) for people with diabetes antibodies but who did not yet have type 1 diabetes. This therapy was the first approved medicine to delay the onset of type 1 diabetes by an average of 2 years.   The CLVer study offers further hope for researchers by showing that another medication can have additional impact in type 1 diabetes, and lays the groundwork for further study. By seeing preserved c-peptide levels in the study participants, the trial demonstrated that taking verapamil improved beta cell function.   Additionally, although AID users had greater time in range of 78% compared to non-users' 64%, which is a 3.4 hour/day difference, the trial found that AID did not provide a significant improvement in insulin secretion. This study was partially funded by JDRF   “Safe, effective therapies are urgently needed to delay disease progression in people recently diagnosed with type 1 diabetes,” said Dr. Sanjoy Dutta, chief scientific officer at JDRF. “This is the second trial showing that verapamil, a cheap and widely used blood pressure medication, can preserve beta cells in the new onset period. The CLVer trial moves us one step closer to our goal of having disease modifying therapies widely available for people with type 1 diabetes.” https://diatribe.org/impressive-results-show-verapamil-preserves-insulin-producing-cells-newly-diagnosed-type-1-diabetes XX Some advances in cell transplantation to treat type 1: Vertex gets FDA clearence for their application to study VX-264, a stem cell-derived, pancreatic islet cell therapy encapsulated into an immunoprotective device with the potential to treat type 1 diabetes (T1D). The VX-264 program does not require the use of immunosuppression, which may broaden the population of people with T1D that this investigational therapy could reach. This clearance means they can begin clinical trials. AND Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™.   These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks. While they are working towards not using immunosuppression, the patients in the current trial do still require immunosuppression to start after implantation of the Cell Pouch SystemTM   https://www.businesswire.com/news/home/20230308005894/en/Vertex-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-VX-264-a-Novel-Encapsulated-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes https://finance.yahoo.com/news/sernova-announces-initial-islet-transplantation-120000700.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAH6NwHdjldrxbueuanlpUGXou6yHP2dKNpYXN31GEMLWCyhkJkgwlhn9ScIDMTX5GGtf5V242uN3EvZzFtTd56z0YZaQgOss37DT2dksdasEONxWa7OOdgnWvDlwUd0-s2RPyMTPi1sw8z08CK6DUMLIrrA6dmCDZeozlwos_CDB XX Two classes of drugs prescribed off-label for some patients with Type 1 diabetes can provide significant benefits but also come with health concerns, according to a study by UT Southwestern Medical Center researchers. The findings, published in The Journal of Clinical Endocrinology & Metabolism, provide a rare view of real-world use of these medications, which are growing in popularity among patients with Type 1 diabetes as adjuvants to insulin. Type 1 diabetes is universally treated with insulin injections. However, explained Dr. Lingvay, because only a fifth of patients with Type 1 diabetes in the U.S. achieve the blood sugar control that the American Diabetes Association recommends, doctors are increasingly prescribing medications known as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and/or sodium-glucose cotransporter-2 inhibitors (SGLT2is) to help patients reach this goal. Furthermore, both classes of medications have been shown in patients with Type 2 diabetes to decrease the risk of cardiac and renal events and help promote weight loss, effects that also would greatly benefit patients with Type 1 diabetes. However, the risk-benefit ratio of these medications has not been fully vetted in this patient population.   In fact, both classes of drugs have been associated with increased risk of severe hypoglycemia and DKA when used in patients with Type 1 diabetes. Because both positive and negative effects of GLP-1RAs and SGLT2is were shown in strictly regulated clinical trials, their real-world effects have been unclear.   To examine their efficacy, Dr. Lingvay, along with colleagues Khary Edwards, M.D., a former Endocrinology fellow at UTSW, and Xilong Li, M.B.A., Senior Database Analyst at UTSW, searched medical records for Type 1 diabetes patients treated at UT Southwestern who used any GLP-1RAs and/or SGLT2is for at least 90 days before Oct. 31, 2021. Their search turned up 104 patients: 65 who had used GLP-1RAs exclusively, 28 who had used SGLT2is exclusively, and 11 who had used both either concurrently or sequentially.   After a year of use, patients on GLP-1RAs had significant reductions in weight, glycated hemoglobin A1C (a three-month average measure of blood sugar), and total daily dose of insulin. SGLT2i users had significant reductions in hemoglobin A1C and basal insulin, a baseline dose delivered outside of meals.   However, SGLT2i users were about three times more likely than GLP-1RA users to experience DKA. Just over a quarter of patients taking either class of drugs stopped due to side effects such as gastrointestinal problems.   The study authors say these results suggest both types of drugs can be beneficial to patients with Type 1 diabetes, but close monitoring is required. Specifically when using SGLT2is, extreme caution is advised in selecting patients with the lowest risk of DKA, performing detailed education about the risk of DKA, and ensuring careful monitoring to prevent its occurrence.   https://www.utsouthwestern.edu/newsroom/articles/year-2023/february-type-1-diabetes.html XX XX   XX Athletic Greens XX COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial.   The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine. About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19.   This meant that overall people who took metformin were 42 percent less likely to develop long COVID-19 compared to people who got the placebo.   The authors also note that the beneficial effect is potentially stronger for people who started taking metformin less than four days from symptom onset compared to people who started the medication four or more days after their first symptoms. The participants who received the two other drugs, ivermectin and fluvoxamine, did not see any benefits in terms of preventing long COVID-19. https://thehill.com/policy/healthcare/3889797-diabetes-drug-proves-beneficial-in-preventing-long-covid-in-clinical-trials/ XX Great article.. https://www.nytimes.com/2023/03/03/sports/baseball/garrett-mitchell-brewers.html XX On the podcast next week.. Ginger Vieira, author and diabetes advocate. Our last episode was with a family whose son was treated with Tzield to delay his T1D diagnosis. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

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.

Our guest today is James Malone, an endocrinologist and health care executive with over 30 years of experience in the field of diabetes. James has seen firsthand the challenges that many people with type 2 diabetes (T2D) face when it comes to daily insulin management. Despite advancements in diabetes care over the years, the process of managing T2D remains just as complex and manual as it was when he first started practicing medicine. While the majority of people with diabetes live with T2D, most of the industry's innovation is focused on complicated systems for "power users" with type 1 diabetes (T1D). This leaves people with T2D struggling with the complex requirements of diabetes management with too few tools to help. James will discuss the difficulties of managing T2D, the importance of self-management, and the disparities that exist between T1D and T2D patients. He will also share his thoughts on what health care professionals and diabetes innovators can do to provide better care for the underrepresented and more prevalent diabetes population. So join us as we delve into the ongoing struggles faced by T2D patients and explore the steps to better care for this patient population. James Malone is an endocrinologist and chief medical officer, Bigfoot Biomedical. He shares his story and discusses his KevinMD article, "Lack of innovation is leading to disparities in diabetes care." The Podcast by KevinMD is brought to you by the Nuance Dragon Ambient eXperience. With a growing physician shortage, increasing burnout, and declining patient satisfaction, a dramatic change is needed to make health care more efficient and effective and bring back the joy of practicing medicine. AI-driven ambient clinical intelligence promises to help by revolutionizing patient and provider experiences with clinical documentation that writes itself. The Nuance Dragon Ambient eXperience, or DAX for short, is a voice-enabled, ambient clinical intelligence solution that automatically captures patient encounters securely and accurately at the point of care. Physicians who use DAX have reported a 50 percent decrease in documentation time and a 70 percent reduction in feelings of burnout, and 83 percent of patients say their physician is more personable and conversational. Rediscover the joy of medicine with clinical documentation that writes itself, all within the EHR. VISIT SPONSOR → https://nuance.com/daxinaction SUBSCRIBE TO THE PODCAST → https://www.kevinmd.com/podcast RATE AND REVIEW → https://www.kevinmd.com/rate FOLLOW ON INSTAGRAM → https://www.instagram.com/kevinphomd FOLLOW ON TIKTOK → https://www.tiktok.com/@kevinphomd GET CME FOR THIS EPISODE → https://earnc.me/8Ly8Mr Powered by CMEfy.

Unfortunately, we missed Diabetes Awareness Month by a few days, but we get great insights on this dreaded disease from two players in the space. Krista Sugerman, vice President, global marketing & communications at Medtronic's diabetes business, shares how diabetes has impacted people close to her and why the company is keeping focused on how a diabetes diagnosis can take over someone's life. We also touch base with newcomer Bigfoot Biomedical. Matt Clemente, Senior Vice President of Product, Development & Delivery at Bigfoot Biomedical, shares his familial connection with diabetes and how he's dedicated his career to helping people manage the disease. Chris Newmarker also delivers his Newsmakers – Elon Musk, GE Healthcare, Boston Scientific, Apollo Endosurgery, Tital Medical, CMR Surgical, and Johnson & Johnson Medtech. Go here to hear the interview with CMR CEO Per Vegard Nerseth https://www.devicetalks.com/hear-from-the-ceos-of-two-surgical-robotics-companies-that-together-just-raised-over-1-billion/

In today's episode, Matthew Clemente talks about the product and engineering scaling challenges working in the biomedical industry. Key Takeaways: An overview of the Biomedical Industry Understanding the Biomedical regulatory overhead on the product roadmap Testing and regulatory issues. Acceleration and efficiencies in the development process. Understanding the team's role & risk management. Mission-driven drivers Connect with Matthew Clemente at https://www.linkedin.com/in/prspctvs About today's guest: Matthew Clemente currently serves as the Senior Vice President of Product & Development at Bigfoot Biomedical, responsible for an innovative, emerging portfolio of diabetes care services and technologies transforming existing care models. Matthew previously served as the Corporate Vice President of Delivery Systems Engineering at Novo Nordisk and as the Senior Director and Chief Technology Officer at Eli Lilly & Company, where he led the development of portfolios of connected drug delivery devices, applications, and algorithms that served as the foundation of both drug manufacturers and connected diabetes ecosystems. Before that, he was the Director of Advanced Drug Delivery Systems at Unilife Corporation. He built and managed an integrated engineering and science organization focused on mechanical, electromechanical, digital, and container closure systems for prefilled, preassembled, wearable drug delivery applications. Before Unilife, Matthew held various roles of increasing responsibility at multiple Johnson & Johnson companies. He primarily served in the new product development of insulin pumps at Animas Corporation for J&J's Diabetes Care Franchise. Matthew obtained a Bachelor of Science in Biomedical Engineering from the University of Miami and an MBA in Finance from Villanova University. ________ Thank you so much for checking out this episode of The Tech Trek and if you enjoyed this episode, please take a minute and leave a quick rating and review on the Apple podcast app! Want to learn more about us? Head over at https://www.elevano.com Have questions or want to cover specific topics with our future guests? Please message me at https://www.linkedin.com/in/amirbormand (Amir Bormand)

This week we'll focus on a few of the exciting companies in the diabetes space. Associate Editor Sean Whooley first tracks down Dexcom CEO Kevin Sayer, who discusses the company's next-generation G7 continuous glucose monitor, which is awaiting FDA approval. Then, Sean speaks with Bigfoot Biomedical CEO Jeffrey Brewer to learn more about what he calls “a transformational attempt” to simplify CGMs with an all-in-one platform with a smart insulin pen cap. Finally, Sean interviews Senseonics CMO Dr. Francine Kaufman about the company's Eversense 180-day CGM, which just received FDA approval. Chris Newmarker brings his Newsmakers of the week including Amazon, Thermo Fisher, HeartFlow, Abbott, Cooper Company and Cook Medical. This episode was sponsored by Accumold. Subscribe to this podcast on major podcast channels.

It's "In the News..." the only diabetes newscast. Top stories this week include: #T1D oral insulin study moves ahead, FDA gives breakthrough designation to new SIGI tubeless pump, study shines light on PBM profits, China demands huge drop in insulin prices and Bigfoot Biomedical launches their Clinic Hub -- 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! ----- Get the App and listen to Diabetes Connections wherever you go! Episode transcription below:  Click here for iPhone      Click here for Android   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. Winner of the American Book Fest Prize for best new non-fiction. Available in paperback, on Kindle or as an audio book – all at Amazon.com. You can also get a big discount right now at diabetes-connections.com – use promo code celebrate to save $4 XX Our top story this week.. More good news for mice.. and maybe some day for people. Yale researchers are looking at an oral medication for type 1 diabetes. These lucky mice had metabolic function restored and inflammation reversed. There are a lot of studies going on to make oral insulin work – liquid insulin is destroyed in the stomach before it hits the bloodstream. This research involves a nanoparticle drug vehicle that can not only bring insulin to the pancreas safely, but the casing itself has therapeutic benefits. It's made out of an acid that seems to reduce the rogue immune cells that destroy the beta cells in the first place. The team says that the nanoparticles could also be used to carry other molecules, which could help with other conditions. https://newatlas.com/medical/oral-insulin-pill-prevents-type-1-diabetes/ XX A new tubeless pump is making its way through the US regulatory process. The FDA gives breakthrough device designation to AMF Medical's Sigi (SIG-ee) Insulin Management System. This is a patch pump, like Omnipod, but it's rechargeable and re-usable – you get two so you don't have to go without while it's charging. It's also an ACE pump, that's alternate control enabled which means it can interact with CGMs and controller devices like smartphones. This designation isn't FDA approval, but it should speed up the review. In the press release the company says, “Clinical study data has shown that Sigi™ is delightfully easy to use.” Which is kind of a nice thing to see in a write up like this. https://sigipump.com/amf-medical-receives-fda-breakthrough-device-designation-nbspfor-its-sigi-insulin-management-system/ XX Big news from the UK this week – they announced everyone in England with type 1 will be eligible for CGMs covered by the National Health Service there. This was preceeded by coverage for the Libre flash glucose monitor. That program was supposed to start at 20% but almost 50% of people with type 1 have opted in and the results in terms of better health and lower a1cs have really been outstanding. Next up, leaders there say they want CGM covered for anyone using insulin, regardless of diabetes type. https://pharmaceutical-journal.com/article/news/nice-proposes-wider-use-of-glucose-monitoring-devices-for-type-1-diabetes XX New research into insulin pricing is shining a light on the middle men.. many of us have known about PBMs for a long time. Researchers at USC found that drugmakers' share of revenue from insulin sales has dropped in recent years — and a greater share is being siphoned off by pharmacy benefit managers, drugstores, wholesalers and insurers. In 2014, 30% of insulin revenue went to PBMs. By 2018, those same middlemen were receiving 53%. Terrific write up as usual by David Lazurs in the LA Times – he lives with type 1 and I always love his stuff. I'll link this one up. The researchers here say since the PBMs are getting a greater share, there's pressure on the drug's manufacturers to keep raising prices so their own profits don't suffer. It's worth noting that these findings were possible because of newer state laws bringing greater transparency to insulin sales. https://www.latimes.com/business/story/2021-11-30/lazarus-healthcare-insulin-prices XX What works to bring down the price of insulin? Ask China. They decided a round of price cuts is due and as a result, 42 insulin products from companies in China and abroad took an average 48% price drop. Otherwise, they wouldn't have been used in that country's public hospitals. Lilly gave up the largest discount: After a 75% reduction, the price of Humalog went down to about $3 per pen. China has been making pharma cut prices for the last few years for other medications. This is the first time insulin has really been affected. https://www.fiercepharma.com/pharma-asia/novo-nordisk-sanofi-eli-lilly-cut-insulin-price-china-s-latest-vbp-off-patent-drugs XX Bigfoot releases some information and reaction to their Clinic Hub. This is how endos and clinics use the data from the Bigfoot Unity System to support patients. Unity launched this summer – it's their smart pen program. When you think about multiple daily injections whether it's for type 1 or type 2.. it's hard for health care providers to see what's going on day to day.. are doses correct, when they're giving, etc. Unity can also include CGM data. This is the launch phase of Clinic Hub.. Bigfoot says they've also added streamlined patient onboarding and more flexibility for patient updates and prescription management. https://www.drugdeliverybusiness.com/bigfoot-biomedical-touts-cloud-based-program-for-managing-diabetes/ XX I'm including the Vertex news here.. we reported this back in October but you probably had everyone you know send you that New York Times article about a cure for type 1 – at least in one guy.. I won't rehash everything here..  it's about stem cells, one patient off insulin but on immunosuppressive drugs..  Personally, I'm very hopeful, but the Times write up overly simplified a lot of this, in my opinion. Good write up in Healthline that I'll link to. https://www.healthline.com/diabetesmine/vertex-type-1-diabetes-research XX In the UK lots of attention on their Strictly Come Dancing competition… when it became apparent contestant Nikita Kuzmin wasn't hiding the Libra glucose monitor on his arm. He wasn't hiding much.. he took off his shirt for this performance. Loads of social media comments applauding him.. for both. By the way, his dance partner, Tilly Ramsey is the daughter of professional chef Gordon Ramsey.. and they were eliminated from the show this round. https://www.express.co.uk/life-style/health/1528577/strictly-come-dancing-nikita-kuzmin-health-diabetes-type-1-symptoms -- quick reminder that the podcast this week is with the UK co-lead on diabetes, Dr Partha Kar. We had a great chat about access and their Libre program and his whole philosophy.. really fun episode. Next week you'll hear from the folks at ConvaTec, they make almost all the pump insets and they have some great info for us all. 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. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

 Techstination, your destination for gadgets and gear.   I’m Fred Fishkin.     New technology to better the lives and care of people with diabetes.       Bigfoot Biomedical has partnered with Abbott Labs to bring to market a smart insulin pen cap…designed to work with Abbott’s FreeStyle Libre 2 continuous...

Big news for Bigfoot Biomedical as the US FDA approves their insulin pen cap system called Unity – which also includes a CGM and an app. CEO Jeffrey Brewer explains what Unity is all about, gives us an update on Bigfoot’s pump system and opens up about his family’s story – his son was diagnosed almost 20 years ago. Plus, in Stacey's first in-person diabetes meetup since COVID, she observed something very interesting about the newer families. 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! ----- Get the App and listen to Diabetes Connections wherever you go! Episode Transcription below:  Click here for iPhone      Click here for Android   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 help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.   Announcer  0:24 This is Diabetes Connections with Stacey Simms.   Stacey Simms  0:29 This week, big news from Bigfoot - FDA approval for their insulin pen cap system called Unity, which also includes a CGM and an app. CEO Jeffrey Brewer says their bundle approach is a bit like Apple’s   Jeffrey Brewer  0:42 Apple takes a bunch of different pieces, some of which they licensed and some of which they make and integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well.   Stacey Simms  0:56 Brewer shares what Unity is all about gives us an update on Bigfoot’s pump system and opens up about his family story. His son was diagnosed almost 20 years ago, plus my first in person diabetes meetup since COVID, where I got good news beyond just seeing my people. 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 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. And when I started Diabetes Connections in the summer of 2015 this week's guest Jeffrey Brewer was my second guest, it is hard to describe what the diabetes technology situation was six years ago. If you were around then you probably remember especially this podcast audience, you know, I tried to talk about it, as I mentioned in the teaser, had a meetup last week with some local parents, which was fantastic. And I'll tell you more about that later. And a mom of a child diagnosed in January of this year asked me what DIY was all about. she'd heard about loop he heard about do it yourself. She wasn't quite sure what it was all about. So that was a long and winding conversation. If you are brand new, and you want to learn more, I recommend searching out the we are not waiting episodes of this podcast. And you can easily search those up at Diabetes connections.com. There's a search box on the upper right. It's a very robust search of our almost 400 episodes now. And you can search we are not waiting as all one word. I've put that in all of those kind of DIY open APS CGM in the cloud. You know all of those types of episodes. I know that six years ago, this pen cap system is not the Bigfoot FDA approval many of us thought would come through First, if you've been following this story for a while Bigfoot was founded in 2014. It was under a different name. It got the Bigfoot name in 2015. But it was founded by a small group of dads of children with type 1 diabetes, including Bryan Mazlish, who got that nickname Bigfoot via reporter looking for the elusive person Bryan who had developed a do it yourself closed loop which his wife and son with type one were using, and the initial headlines for Bigfoot, were all about bringing that closed loop system to market you can go back and see their initial funding press releases, which say things like you know, “the funding will support final development activities for Bigfoot’s Smart loop, automated insulin delivery service, the world's first Internet of Things medical device system delivered as a monthly service.” Bigfoot Unity, which is what we're talking about today is going to launch as that monthly service. It's such a great idea to cut down on the complexity, it's going to help so many people on multiple daily injections, but I know that this podcast audience leans very much into the pump closed loop give me all the tech news group. And I think it's important to acknowledge that that said, My guest is Bigfoot CEO Jeffrey Brewer. His son was diagnosed with type one in 2002 and as the former CEO of JDRF. Brewer led the artificial pancreas project there. In life before diabetes, Brewer founded and led early.com startups including city search and goto.com. We will find out all about Bigfoot Unity in just a moment but first Diabetes Connections is brought to you by Gvoke Hypopen  and you know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're going to pass out there are a lot of symptoms and they can be different for everyone. I'm 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 fever. 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. This made emergency situations even more challenging and stressful. This is so much better. 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 com slash risk. Jeffrey, thank you so much for joining me, I really appreciate it.   Jeffrey Brewer  5:05 Thanks for having me. Glad to be here.   Stacey Simms  5:07 So I looked back at my notes, you were my second guest on Diabetes Connections back in the summer of 2015, talking about the big plans for Bigfoot and holistic systems, and then lots of things that you said at the time you couldn't really talk too much about. And now here we are. So first of all, thanks for being my guest way back when when, you know, probably have three people listening, I really appreciate that.   Jeffrey Brewer  5:29 Well, thank you, and thanks for sticking with us maybe took us a little bit longer than I had hoped. But we're finally here to be able to offer something to people with diabetes, that we hope it's going to improve life and make it a little easier.   Stacey Simms  5:43 Definitely. Well, let's talk about that. So we're talking about Bigfoot Unity, would you mind kind of going through who it's for what it does, this is a system that is going to help people who are on multiple daily injections. So what is big for Unity?   Jeffrey Brewer  5:57 Yeah, so as you know, had Bigfoot developing a range of solutions to help people whose lives are dependent upon insulin to live safely and, and hopefully better lives. We are in this journey, focusing first on multiple daily injections, basically, intensive insulin therapy, once a day, have a basal insulin, and then given shots at mealtimes, or for corrections of rapid acting insulin, that particular therapy, which about 3 million people in the United States today do on a daily basis, about half people with type two diabetes, about half people with type one diabetes, but it's really the same therapy, we have developed a system that we believe solves a lot of the problems that therapy has, when it comes to the ability of people to determine the right dose for themselves on an ongoing basis, and also for health care providers to support them in doing so over a long period of time. I   Stacey Simms  6:53 totally understand because years ago, my son wanted to take an insulin pump break, he has used an insulin pump, since he was two, really six months after diagnosis, we got him on a pump. And we were so frustrated. Because not only did we have to do all the math manually that the insulin pump had done, there wasn't. And this was really before, there were lots of apps and things, there was no way to do all the stuff that the pump does in terms of insulin on board, and that kind of thing. So I assume that those are just a few of the features that Unity will provide   Jeffrey Brewer  7:23 some of the things that a pump does BigfootUnity will help to support your right that for people taking shots, it's mostly a glucometer, a piece of paper with some instructions and a couple of insulin pens. There isn't a lot of technology involved in those people's lives right now. And what we've done is develop a package of technologies that includes some devices, and some software that is knitted together for ease of use, to make life convenient for the person to first of all, be prescribed the therapy to be trained how to use the therapy easily and safely, and then to over time be supported by a healthcare provider who has the responsibility of supporting many of these patients, we are bringing technology to a population of people who I think have been largely overlooked, because most of the innovations have been focused on pumps. And that's really been focused on type one and also focused on very highly engaged people with diabetes that frankly, had to do a lot more in order to support the therapy and seen by doctors who are very excited about the technology. But not everybody sees a clinician like that. And not everybody wants to put everything into their insulin therapy that maybe a pump would require.   Stacey Simms  8:42 So take me through a little bit of it if you could, when I looked at it, I was kind of making notes that I wrote white cap black cap. So the white cap is for the fast acting and that gives you a dose, like a pump would say here's the suggested dose.   Jeffrey Brewer  8:56 Sure Bigfoot Unity is a bunch of different things together at the centerpiece of the system is these taps that are going to be for the particular insulin that a person is prescribed, whether it is an insulin made by Novo Nordisk or Sanofi or Eli Lilly, we have caps that fit all the different disposable insulin pens for both the basal insulin and the rapid acting insulin. First of all, you get these caps that fit the insulin that you've been prescribed. You also get a couple freestyle Li braise, you get a blood glucose meter that talks to the caps as well. You get in this first time experience kit, everything down to the pen needles and the alcohol swabs that are going to be used for parasite before you put on a sensor, literally everything that you need in order to initiate multiple daily injection therapy with the exception of the Insulet itself. It's all in this box. So this box comes to a person with diabetes in their home. We train them to use the system through a digital interface that we've developed support. onboarding to our system but also for people who are cgmp may never have bought a CGM before will literally through a zoom interface, walk them through the first experience with CGM, and then train them on the whole system. And the centerpiece of the system, as I said, as these caps, which basically do a simple thing they keep track of when you last gave yourself insulin. And they do calculations that are necessary in order to recommend how much to take based on your doctor's direction, very simply on the blackcap, which is focused on the basal insulin, you have one button, and you can only press the button and cycle through screens. So you press the button. first screen says this is when you last took the dose. So it could have been say 23 hours ago, and it's time to take another dose, you press the button again, and it's going to tell you how much you should take. And that's what you were prescribed by your healthcare provider. And what can be updated in the cloud, by your healthcare provider. Rapid acting cap, the white cap is got some additional functionality, but still works the same way. It's got a screen on it, and then you press the button, the first screen is going to have when you last gave a shot, which is particularly important for stacking insulin as you refer to insulin on board. This is one of the big challenges that people who are on shots have is that they don't have a record of when they last took the shot. And so actually making sure that they don't treat the same high glucose reading too quickly, and then end up with too much insulin and end up low. This is something that we help with by actually keeping a person from stacking insulin. So you press this button, it's going to tell you when the last took a dose, if within three hours, you had taken a dose previously, it's going to lock out a correction. And therefore you're not going to make that mistake. This cap also interfaces directly with the freestyle library to or a blood glucose meter, and basically takes that data and directly translates it into a correction dose if you are taking your correction based on again what your healthcare provider had prescribed. So whether it's a correction factor or a sliding scale that was written down on a piece of paper, you don't have to remember or do any calculations, it basically just takes the number from the libri and turns it into here's how much insulin I should take. And if I had previously taken insulin that keeps me from over insulinizing and stacking insulin   Stacey Simms  12:16 over insulinizing? Is that an actual word?   Jeffrey Brewer  12:22 Yeah, I think I heard that from one of the researchers one time, so   Stacey Simms  12:25 we're claiming it if it's not, it's a rage bolus or it’s over-insulinizing   Unknown Speaker  12:29 There you go.   Stacey Simms  12:30 I didn't mean to interrupt you, sorry.   Jeffrey Brewer  12:32 No, no worries, the next step, after you take a correction, maybe you're going to have a meal. And having recommendation for how to dose from mealtime. It actually turns out that small, medium and large is a format that a lot of people are able to understand and work with in terms of how to take carbohydrate content and actually correlate that with an insulin dose. It's actually the minority of people, even in type one, but certainly with type two that carb counts. And so thinking about this in a different way, and a simpler way, where you have maybe small medium and large buckets, and a corresponding number of units for insulin that shows up right on the pen cap. If you want to add the two together, you are going to click the button again. And then it's going to basically add a correction to whatever the meal bolus would be, you're going to pick that value that you're choosing as a patient, because we're not deciding for you, we're just telling you, here's what your doctor would recommend based on all the calculations that you usually would do, if you had to do them. If your doctor were sitting there with you, this is what he or she would recommend you do. But if you know more, because for instance, you know, you're going to be exercising vigorously later, and you want to protect against hyperglycemia a person might decide to take a year or two less. But basically we're going to get them all the information that we can take it and make it actionable for them take as many steps out as we can to just get them to the answer they want. Because I don't actually think people want to know what their blood sugar is. They want to know, what do I What should I do? How much insulin Should I take. And so every step we can remove, and every thing we can take out of this equation to make it easier for people to stay healthy and take the right amount of insulin and then forget about diabetes for another four hours until another meal. That's what we're trying to do. And we're trying to do that for people who take shots, which is most of the world in terms of multiple daily injection therapy is the preponderant therapy for intensive insulin usage.   Stacey Simms  14:28 I appreciate you going through so granularly, I have learned that my listeners really like the deep dive anytime there is something new. So thanks for walking us through that. And you've mentioned the CGM. Let's talk about this. This is all integrated with the Libra when people use the Libra does it alert? Right back to Jeffrey answering my question but first Diabetes Connections is brought to you by Dario health and one of the things that makes diabetes management difficult for us that really annoys me and Benny isn't actually the big picture stuff. It's all the little tasks adding up. Are you sick of running out of strips? Do you need some direction or encouragement going forward with your diabetes management with visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that and more No more waiting in line at the pharmacy no more searching online for answers. No more wondering about how you're doing with your blood sugar levels, find out more go to my dario.com forward slash diabetes dash connections. Now back to Jeffrey Brewer answering my question about using the abbot libre here, does it alert an alarm?   Jeffrey Brewer  15:40 Very good question. So the way the library works is it gives data in two different manners. One is you take the pen cap and you swipe it over the library. And it gives you an on demand reading for what your glucose is at that particular moment. And that's the value that is used in order to calculate any corrections. But there's another way that libri is communicating, which is directly through Bluetooth to the smartphone. Because we have an app on the smartphone. And that's monitoring. For instance, for hypoglycemia, you have a couple different ways the library is working in order to support a person with diabetes, it's either directly on demand to make the calculation on the pen cap or go into the phone for monitoring for hyperglycemia. These are particular capabilities of the library to   Stacey Simms  16:27 his delivery that is in big for Unity. Are there any different features? Or is it the same one that people can buy separately?   Jeffrey Brewer  16:34 Well, it's the same libri puck. So the sensor itself, the part that you wear on your body, it's the exact same one that gets prescribed and fulfilled at the pharmacy or wherever else a person gets their lead rays. The difference is that we're not using the reader that avid makes, or the app that avid will have on the phone, the libri in our context is talking directly to our pen caps and to the app on the phone. So it's fully integrated into the system. This is an amazing thing that avid has given us, which is the ability to make it very, very simple for the end user such that you don't have to apps you have to worry about all the training is comprehensively designed such that I learned to use the library and the context Bigfoot system, one training one app, one company that's gonna support the whole system, Bigfoot, and then all the data that gets captured, whether we're talking about insulin data or glucose data, and then made available to clinicians in a unified interface to support them in adjusting the therapy over time.   Stacey Simms  17:38 Well, this may be a really dumb question. I know that the Libra you scan with the phone, when it's separate from Bigfoot in Bigfoot Unity, do you scan with the pen? Or is it just automatic,   Jeffrey Brewer  17:48 it's with the pen, you scan. That's actually the only way you can get right now what's my glucose reading from the CGM is through that NFC interface on the library puck. And one of the key design elements that we felt very strongly about is that you don't have to open up an app on a phone, in order to give yourself a shot. Literally, you're just carrying that pen which you would have with you for meals during the day, it already has the pen cap on it. So you don't carry another device and you're wearing the Libra on the back of your arm, all you have to do is wear the Libra Ray, and then scan that Libra with the pen cap, then it tells you what to do. And no opening an app on the phone, no unlocking the phone, selecting an app opening and navigating through pages, that adds too many steps. And it's frankly, peep something people don't want to do. So we tried to make it as close to what they're doing today, which is you've already got a pen that you're carrying around, we're not adding another device, you don't have to add any additional steps, all you got to do is wear the LIBOR rate and we take that data and then make advice as to what to do.   Stacey Simms  18:54 You know, one of the issues with pens is that they'll switch you insulin brands. So you know the insurance when your will cover human log the next year it wants you to take novolog and the pens aren't the pens different the caps fit and the different pens geoffry.   Jeffrey Brewer  19:08 The pens are different between the different manufacturers. And then some cases from the same manufacturer, you have different designs, different diameters and geometries and clearance for the needles. What we've done is besides designing different pen caps for all the different insulins, we have basically supported this as a service offering. So when you're using Bigfoot, if you didn't buy a pen cap, you are a customer for the entire offering. And if you get switched by your insurance company from humulus, novolog or back, we're just going to send you the new pen cap that fits the insulin that you're currently prescribed, which is we think one of the big challenges that people have and we've heard and we wanted to make sure that that was an easy transition for people.   Stacey Simms  19:54 That's great. And you've already mentioned the way it's packaged, but I'd like to just talk about that. Little bit more I remember. And it was either when we first talked in 2015, or you know, some point very early on that you all were adamant that this was not going to be piecemeal. And you were also going to make it easier for people to purchase things all together. So this is, this is a terrible way to describe it every in my head, I sort of think of those boxes, the subscription boxes, people get right with my kids, it was like, you'd get little fun comic book stuff in them, right, or you'd get a subscription box of exciting bath luxury items. This is obviously not that this is a box with everything in it, right, everything comes together.   Jeffrey Brewer  20:34 That's right, when you first initiate therapy, you don't have to go and get a prescription filled, really braise a prescription field for a blood glucose monitor for test strips for lancets. For pen needles, basically, it's all there in the box. And it's trained and set up in a unified fashion. That frankly, just makes it easier to learn. And it makes it more convenient. And we thought that's an important part of the customer experience. There's a lot of blaming, that takes place of the patient in the world that says, Well, people just aren't working hard enough. They're not doing the things that their clinician told them to do. If they were everything would be better, and diabetes wouldn't be a problem. And frankly, we just don't agree with that. We think that it's too complicated, it's too hard. And that it should be easier. So one of the things that needs to be easier is all the different supplies and getting those and making sure you have the right supply. Having access to the tools is something that needs to take place in order for you to be able to successfully use the therapy, we figure if we make that easier if we make it easier to remember things or you don't even have to remember things because we remind you or we descend them to you without you having to remember all that kind of stuff, I think really adds up to a better experience easier and more convenient use of the system, we firmly believe it's going to end up in better results. Because it's just people are going to do things that are more convenient and easier for them to do. So we make it as easy as possible.   Stacey Simms  22:03 any issues getting insurance and Medicare coverage when it's all bundled like this. I mean, I'm asking is did Bigfoot have any issues getting it? And is it covered for people now?   Jeffrey Brewer  22:13 Why Yeah, there's a lot of innovation that we're having to undertake in order to be able to deliver this to people. One of the aspects of innovation is that we're working through clinics, or endocrinology practices. And this is how we deliver the solution, the clinician will prescribe and then bill for not only the system, but the services of the clinician to use the system and support the system for the person with diabetes. And then when bill comes in, it comes from the clinician. So in order to make this simple, so that there aren't all these different prescriptions. And there aren't all these different places where you have to get all the different pieces, we're working through the clinician. And in this case, there are already codes that are available called remote physiologic monitoring codes that support the treatment of chronic disease and tools in order to support better treatment in chronic disease. And so we're providing these tools to the clinician, and then the clinician basically delivers them through to the patient. And the billing relationship is between the patient and the clinician. All of it gets simplified and makes everybody's life easier. What we're doing is covered by Medicare and private payers more broadly, because we didn't go and get a code for Bigfoot, what we did get is a plan to go and use codes that are already there that clinicians can access in order to reimburse both for what we're providing, and for the services that they have in order to support the effective usage of the system   Stacey Simms  23:46 looking forward, because of course, we can never just let something come out, we always have to see what's next. You know, we talked a lot about interoperability is Unity, going to integrate with different cgms or different systems down the road is that in the plans,   Jeffrey Brewer  24:00 not in the immediate plan, what we did is we said, we're going to pick what we think is the best CGM for what we're trying to do, which is simple, easy, cost effective and very scalable across a large population. And the library has some very unique capabilities that that we feel very much support what we're trying to accomplish. And so we did a deep partnership with avid, as I said, they've given us the ability to integrate their sensor into our system in a way that other systems are not integrated closed loop systems. Today, you have a company that sells you a sensor, you have a company that sells you a pump, they have different apps on the phone that are going to govern, you know their respective products, they're going to be uploaded to clouds that sometimes require clinicians to look into different places to see the full picture for data. We're doing something much simpler. Describe what we're doing is more like what Apple does. Apple takes a bunch of different pieces, some of which they licensed and some of which they may integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well. There are other sensors out there and great options for other sensors. We're not trying to say you have to switch to us if you're happy with your other solution. We're trying to go after a population of people who literally don't have any solutions today and are feeling pretty ill served. We think that with all the people out there that are still to use CGM are still to benefit from CGM and the kind of tools we put around CGM. We don't see ourselves as competing with others. We're just trying to get the goodness that we believe we've created out to people who who need it,   Stacey Simms  25:39 I got a question from a listener I meant to ask we were talking about scanning depends. And that was, if a person can still use the the libri, to reader and the librelink app to scan the sensor. Or once you do this, if it is only linked with Bigfoot system?   Jeffrey Brewer  25:53 Well, in order to get the benefit of the system, you need to use the pen caps, because that's where the data is captured. That's where the recommendations get made. And it works best in the context of the Bigfoot system.   Stacey Simms  26:05 So you can't you can't link it to two different things. In other words, you couldn't use the reader and the pen.   Jeffrey Brewer  26:10 Not at the same time, you could use the library separately with a library reader and a librelink. app, but not at the same time.   Stacey Simms  26:20 I'd love to get an update Jeffrey, if you could on what I believe is called Bigfoot autonomy, which was the pump system that we did first talk about all those years ago? Can I ask you what the plan is for that, or what you could share with us about it, it is called Bigfoot autonomy, right?   Jeffrey Brewer  26:35 That is the name that we have picked for it. Yes, autonomy and Unity Unity use for the shots and autonomy is for the pumps, we have, as you know, a pump ourselves, we have developed and done clinical work for algorithms that we have utilized for closed loop insulin delivery. And we've also developed the full package around how to deliver it as a single thing, using a libri. In a very parallel fashion to what we've done with a foot Unity, we had to focus on one product in order to launch the company and to establish ourselves. So we picked this path because we think it gives us the opportUnity to reach the most people most quickly that frankly, don't have other options available to them. And we think we're going to be able to establish a reputation in the marketplace. In the future Bigfoot autonomy is going to complement Bigfoot Unity and present another option for how people can have insulin therapy. That is something we're committed to down the road.   Stacey Simms  27:34 So the people that were very enthusiastic, there's this this whole commUnity that was you know, the DIY commUnity and the we are not waiting commUnity, they should not look at Unity and say, well, Bigfoot has stopped with the pump, right? They shouldn't think that this is not going to go forward. It's not still in the plan.   Jeffrey Brewer  27:51 Well, the plan is always and will remain that we're offering choice and selection of different opportunities for people that have different needs. Just as Medtronic today, in acquiring the companion in pen now realizes it's not about pumps or pen, it's about both, we've been saying the same thing for quite a while, we're just starting with the pens, and then expanding to the pumps, versus everybody else is now interested in pens and started in pumps, it's really the same thing. It's a different way of serving a particular part of the population that has different needs, pumps are great. And they can deliver a lot of value and a lot of quality of life. However, they're not going to be right for everybody. And there's going to be a lot larger population of people who will still take shots for the foreseeable future, especially globally. And so it's not a matter of either or it's both in our minds,   Stacey Simms  28:43 if your son is living with type one for almost 20 years now. And of course, I think most people got familiar with your name when you were at jdrf really pushing the artificial pancreas program. I wonder if you could just take a second to give us some perspective, because I don't know about you. But my son was diagnosed in 2006. And it almost seemed like for the first eight years, maybe even 10 years, there just didn't seem to be that innovation on the commercial side of things. And now, I feel like I know it's it's not there's no cure. I know it's we're not there yet. But I do feel like the technology is finally working hard. You know, we're doing things for my son. And it's not just pump technology, as you said it's pen technology. And I feel like at least he can do a little less work.   Jeffrey Brewer  29:25 I feel the same way. There's been a tremendous amount of progress from 2002 when my son was diagnosed in 2012. There wasn't much of any progress. It has been accelerating in recent years. And I give a lot of credit to jdrf and the work that the volunteers supporting jdrf did to advocate to the executive branch to the legislative branch and then directly to the FDA, we were able to establish a very strong platform for collaboration and the way the FDA has prioritized the innovation in diabetes. enabled it with some clear rules of the road. I believe that's what made it all possible. There has been development of technologies that weren't mature before. But if they didn't have a path through to the marketplace, through the FDA process that worked, we wouldn't benefit from all these things. So it has been a journey. And I think it's been, you know, development of technology. It's been developed in the regulatory practices. It's been greater familiarity and openness amongst clinicians, and also the payers who see value and these tools for patients. So a lot of things that had to change, healthcare is much more complicated and difficult to work in than what I previously did in my high tech career. But it's much more rewarding, because I think it's now having a big benefit and a lot of people and we're happy to join the party, as Bigfootbiomedical.   Unknown Speaker  30:47 Do you mind if I ask how your son's doing?   Jeffrey Brewer  30:48 Yeah, he's actually doing very well with his diabetes, I will tell you that between the ages of like 15 and 22, it was kind of rough. It was a very similar story that I heard from many parents when I was a CEO of jdrf. It's a really challenging condition to live with adolescents and young adults. But he sort of found his way through that, and now has refocused on taking care of himself. And the tools are better now, to enable him to do that. So I think that it's gone hand in hand, his maturation and the development of these tools. And you know, I think he's in a good place. And hopefully, we can make it better over time. You know, it's   Stacey Simms  31:27 funny, I'm not quite sure this is gonna come out appropriately. So I'll try to be careful. But it's kind of nice to free in a way to know that even the head of jdrf. And even the guy at Bigfoot has a kid who was a teen, and struggled. And I know that sounds weird. I don't wish anybody to struggle. Like I wish all the kids went through this, and we're fine. And everybody was the poster child. But I appreciate you sharing that.   Jeffrey Brewer  31:50 It's important because I don't think that people talk about it enough. How hard it is for families, how hard it is for the kids, and how young adults, their brains are just not meant to cope with a responsibility like this. It's just not right. It's not something that they're ready for. And, you know, so nobody should be surprised that it's very hard. And it certainly journey. I think it'd be better if people understood that from the beginning, you know, because some people yeah, you're right, they think it's just my kid that's having this trouble. But it's not, it's that this is really, really hard for any family. And it frankly, is the rare family, where you have just a completely well adjusted and easygoing kid with type 1 diabetes. That's the rarity, not the norm. We're a company that stems from the patient experience, you know, my knee through my son, obviously, it's not the same thing as having it. But you know, having a child that grew up with it, a lot of people at Bigfoot have insulin requiring diabetes and know what it's like to live with this drug. I think it's given us a really great perspective on some of the softer aspects of the experience have been missed by some of the medical device companies, things about making it easier and less stressful and just more convenient. Because when you got to do something every day, multiple times a day for the rest of your life, it's just a different kind of thing. And even small benefits to simplicity can have a huge impact and adding up to much less burden, emotionally or intellectually. And I think that all adds up to better lives. We can't point to any one thing about Bigfoot Unity and say, this is the thing that really makes the difference. It's really a bunch of different things that are really holistically designed to as a system, the sustainable and usable on a daily basis. And I think that's really the future of chronic disease and, and we're glad to be able to help tell that story.   Stacey Simms  33:45 Well, thanks for spending so much time with me. I really appreciate you going through it. And I'm sure we will talk again soon. Jeffrey, thanks so much for being with me.   Unknown Speaker  33:57 You're listening to Diabetes Connections with Stacey Simms.   Stacey Simms  34:03 Lots more information about Bigfoot. I will link it up in the show notes at Diabetes connections.com. I have been hearing some weird things about Apple podcasts player recently and some of the other apps that feed off of apple. If you're having any trouble getting links, or even listening to the show. Everything you need is a Diabetes connections.com transcripts of every show. And always please get in touch with me I can usually help you find what you need. Because these are pretty information, dense episodes. And if you prefer to read, I want to make sure you get the info. And if the app isn't helping you then we can help you in a moment. Something really amazing about my recent diabetes, parenting meetup, I met some new families and it was really unusual their experience and what they're doing for the rest of us. It's complicated, but I'll tell you in just a minute. First Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom back in December of 2013, the share and follow ups weren't not an option. They hadn't come out with Technology yet. So trust me when I say using the share and follow apps makes a big difference. I think it's really important to talk to the person you're following or sharing with. Even if you're following your young child, I'm telling you, these are great conversations to have, you know, at what number will you text? How long will you wait to call that sort of thing. That way the whole system give everyone real peace of mind, I'll tell you what I absolutely love about Dexcom share. And that is helping Benny with any blood sugar issues using the data from the whole day and night. And not just one moment, internet connectivity is required to access separate Dexcom follow up to learn more, go to Diabetes connections.com and click on the Dexcom logo.   Okay, it was jumping out of my skin last week, because I had my first diabetes parent meetup since COVID. I think the last one might have been January or February of 2020. Many of you know I run a very large Facebook group for parents of children with type one in the Charlotte area, I think we have almost 1000 people now when we were starting to pull from all over the state because I have come to find out it's a pretty unique group. If you have a local group that you run, or you're part of what makes it unique is mine is based on meeting in person, I try to really stress and set up you know nothing official, I'm not with any organization, I just say hey, let's meet for coffee here, I stress the idea of let's get together in person, let's get the kids to meet let's get the parents to meet. And it can be kind of hard because not everybody I have found is as I don't know if enthusiastic is the right way to put it or pushy or not shy, maybe it's just I'm not afraid of rejection. If I set up a coffee and I invite you know, the whole 1000 people group, and five people show up or one person shows up, I'm still really happy. And I've come to find out that not everyone feels that way. So don't be shy. Just put your stuff out there, get people to come and meet up with you. It will change your life. It really helps me 14 years into it, I think more than anybody else who comes to these things. So I set one up, we only had two people come I'm telling you these things are still amazing. But they were both newer diagnosed families. One had a nine year old daughter diagnosed January of 2021, just this past year, and the other had a 16 year old boy who was diagnosed last summer. And it turns out and I knew this before we met we the kids have some mutual friends. And they're both wrestlers. So Benny knew this other kid as well. But what was amazing to me is that both of these families were already enrolled in clinical trials. And they had been presented with this option. So early on. Now we do not live in an area where clinical trials are present. I mean, I've talked about this on the show before it's we've never been able to get in one. We live in Charlotte, North Carolina, most of North Carolina trials and tests and things are in the Raleigh area over by the Research Triangle, or they're in Virginia, at UVA, or Florida. And that's really the closest to us. So that's where these two families both went for separate trials, both at University of Florida health both I believe at trial net, I may have the exact place but both with Dr. Michael Haller, who we've talked to several times before on this show, one of the kids that the 16 year old is in the Teplizumab trial, the other is in the ATG trial. I'm not going to go into detail on both of these, we've actually talked to Dr. Haller about both of them on the show before. So I will link that up in the show notes as well. But I'll tell you what the ATG trials you've just started. So it's a little too early to tell anything. And of course, this is just with one person. So we should be careful about drawing conclusions. But the 16 year old wrestler, holy cow, so he was diagnosed last year, it's almost a year I believe in In fact, when this episode comes out, it might just be a year. And this is a 16 year old kid. So a teenager who uses probably a lot of insulin, right big kid healthy kid. And I want to say the dad told me that his daily basil is four units. And they're struggling using a pump because he gets such low doses of insulin. They're trying to figure out what to do. Now, who knows, because as I said, it's early on, but it seems to be the thinking that the diploma has really helped make this first year of diabetes, very different than what most 15 or 16 year old kids go through in their first year of diabetes. I'm going to talk to the family. I'll probably circle back around with Dr. Haller again. Because I think that their experience and honestly, it has not been an easy experience. This isn't you know, you go down to Florida, you take a pill you come home, it's a very intense, but brief experience, but they do go I believe, every six months. So I'll tell you more about that as we get there. But I really wanted to bring up with how amazing that these newer families are helping in this way. Obviously they want to help their own children, but they also understand that this is helping the greater commUnity. These are opportunities that did not exist. 14 years ago, when Benny was diagnosed that did not exist possibly, you know, 10 years ago, we have to pull him up in front of the FDA right now. This is really interesting to me, and I know it is to us. You're listening if you're listening this far into the show, certainly, but man and I know I also live in a more affluent area people have more access to health care and to doctors who know about this stuff. But Wow, I was surprised so happily, so To hear that and and to see that their entry into the diabetes community was also an entry into studies that will help everybody you know whether this stuff works or not, it all helps. So I really appreciate it.     Okay, before I let you go update on events, my next event is not in person, we're still on zoom for a lot of us but getting in person for more, which is so exciting. On June 5, I'll be speaking at Camp Nejeda. They have a great event for adults with type one, I will link this up in the show notes. And in the Diabetes Connections Facebook group, I'm talking about telling your story and advocacy. So this is more about how to get the media to listen when you want to talk and also maybe just about blogging and speaking Yeah, blogging still Sure why not in podcasting, and tik tok and Instagram, but talking about your story, and advocacy. That's what I'm going to be talking about there. If you're listening in the Charlotte area, we are doing another D parent meetup. That's This Week. If you're listening as the episode first goes live, it'll be Thursday evening. So drop me an email or hit me up on social and I'll give you all the details. And of course, every Wednesday, Diabetes Connections in the news, join me 4:30pm Eastern Time live on Facebook for a very brief five, six minute newscast about what's going on in the diabetes world, all types of diabetes, and that's replayed on social through the rest of the week. And the response to that has been great. So I am going to keep doing it. I'm having a lot of fun with it. All right. 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 next week. Until then, be kind to yourself.   Benny  41:40 Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

It's "In the News..." the only LIVE diabetes newscast! In six minutes, we'll get you up to date on these stories and more: A weekly basal insulin moves forward in trials Bolus by phone comes to one pump system Big study shows how people managed diabetes during COVID Saliva test for glucose in trials Watch the video: https://youtu.be/X0JMDubA1c0 Join us LIVE on Facebook every Wednesday at 4:30pm EDT Sources & links in the transcript below 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:  Hi, and welcome to Diabetes Connections In the News! A short weekly newscast full of the top diabetes stories and headlines of the past week. I’m Stacey Simms & whether you’re joining me live on Facebook or watching or listening after, I’m here to get you up to speed quickly XX In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff” In The News this week.. XX A potential once-weekly basal insulin is moving ahead in studies. These two trials looked at the safety and efficacy of a modified version of insulin called insulin icodec. Every participant – and they all had type 2 - was also taking an oral glucose-reducing medication that was not insulin, such as metformin. An extensive phase 3 program is underway –this includes people with type 1… it also will include people new to insulin and those who’ve already used it. Weekly Insulin Icodec could potentially take the place of daily basal injections. Weekly basal insulin: https://www.medicalnewstoday.com/articles/once-a-week-insulin-treatment-may-be-a-novel-way-to-treat-diabetes#Toward-a-less-burdensome-injectable XX Roche today announced the launch of the mySugr Pump Control, which lets you work your insulin pump directly via a smartphone. The first pump to be controlled with the mySugr app is the Accu-Chek Insight. This is only available in Austria right now, where mySugr is based, and on select Android phones. It will launch in more European countries soon. All the U-S pump makers are working toward bolus by smart phone but no approval yet. Interestingly, Roche calls the mySugr Pump Control an important building block within their integrated Personalized Diabetes Management or iPDM. If that sounds familiar, it sort of leads us into this next story.. Roche & MySugr launch bolus by phone: https://www.prnewswire.com/news-releases/roche-launches-mysugr-pump-control-within-the-mysugr-app-to-simplify-insulin-pump-therapy-via-smartphone-301294085.html XX Pump lawsuit in the UK. Insulet is suing Roche Diabetes Care claiming that Roche is selling tubeless insulin pumps three years before Insulet’s patent expires. The suit was filed last year but the trial just began in the U.K. High Court. Insulet claims that Roche has been infringing the patent on its Omnipod insulin pump by marketing their Accu-Chek Solo pump since mid-2018. Insulet has asked the court for an injunction to stop Roche from marketing these products. It is also asking for unspecified damages. https://www.drugdeliverybusiness.com/insulet-sues-roche-over-diabetes-tech-patent/ XX Is there a relationship between marital status and diabetes risk? These researchers say yes. Biggest finding? Men who are divorced/separated have increased risk for diabetes, and women who are widowed are at increased risk The usual assumptions here about men eating healthier while they’re married and women perhaps over-eating after the death of a spouse due to stress and because they’re not taking care of anyone anymore. . However, food doesn’t seem to actually be part of this study. So I think you have to be careful about that conclusion.. these researchers do say the big take away here is that other studies don’t differentiate between non-married or divorce… and widowed, which they say makes a big difference. https://www.dovepress.com/diabetes-mellitus-and-marital-status-evidence-from-the-national-longit-peer-reviewed-fulltext-article-IJGM XX New study from the American Diabetes Association and dQ&A, finds that growing numbers of people with diabetes have not only been forced to put off needed medical care since the outbreak of COVID-19, but that alarming numbers are struggling to manage their blood glucose levels. Key survey results found: Nearly 1 in 5 Americans with diabetes have skipped doctor's appointments since the start of the pandemic, mostly due to fear of contracting the virus; 1 in 4 people report having trouble controlling their blood glucose levels 1 in 10 say they have developed new health complications like high blood pressure, heart problems, peripheral artery disease, and eye disorders since last March. ADA COVID & Diabetes study: https://www.johnsoncitypress.com/covid-fears-kept-one-in-five-people-with-diabetes-away-from-the-doctor-during-pandemic/article_ffcb98a9-55df-58ad-a010-c7acd12070bb.html XX A saliva test for glucose levels? That’s coming up but 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 when a belief thought to be settled science turns out to be wrong. And to illustrate that point they talk about the horse poop crisis of New York City. Really. Listen to Inside the Breakthrough wherever you listen to podcasts.. XX Back to the news.. A South Korean company is seeking the approval of both the US and Korean Food and Drug Administration for the commercial rollout of its saliva-based glucose monitoring device after completing its first clinical trial in December. The device called D-SaLife, uses something called a microcurrent control technology to determine the glucose level present in a saliva sample. They say they will move to clinical trials in the US – that first one was in in Seoul – but no date so far. D-SaLife is not the only saliva-based glucose test in the works. There’s an Australian company that’s testing a disposable strip. Glucose saliva test: https://www.mobihealthnews.com/news/apac/south-korean-chipmaker-bats-us-fda-approval-its-non-invasive-glucose-monitoring-device XX And finally, this one caught my attention because the headline says Gnome Man begins 380 mile walk to type 1 diabetes camp. Turns out Richard Humphreys runs the Gnome Countryside Nature Trail in Pennsylvania. But he is 78, has lived with type 1 for 64 years and really is walking 380 miles to raise money for Camp Ho Mita Koda – the world’s oldest operating summer camp for children with Type 1 diabetes in Newbury Township, Ohio. Good luck Richard and wow. Thank you. Gnome man walks to D-camp: https://lancasteronline.com/news/local/watch-kirkwoods-gnome-man-begins-380-mile-walk-to-type-1-diabetes-camp-in-ohio/article_8a5bc632-b669-11eb-a02a-f7a41b012ed6.html XX 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 one of the founders of Bigfoot Biomedical about their new FDA approval and also what it means for other products in their pipeline. Thanks and I’ll see you then!

CaptureRx ransomware attack exposes patient information from multiple provider systems; Insurers are concerned that telehealth reimbursement parity may lead to overutilization. Also: Bigfoot Biomedical receives FDA clearance for its Bigfoot Unity Diabetes Management System.Links to the stories:Thousands of patient records exposed after ransomware attack on CaptureRxTelehealth reimbursement parity spurs insurer concerns of overutilizationFDA greenlights Bigfoot Biomedical's insulin recommending diabetes management system

Techstination interview: FDA clears smart insulin pen cap from Bigfoot Biomedical: CMO Red Maxwell

On Episode 193 of Health in 2 Point 00, we have another huge day! We catch up on Amazon's telehealth news before covering more massive deals. Evidation gets $153 million, bringing their total to a whopping $259 million and Komodo Health gets $220 million, bringing their total to $319 million. Bigfoot Biomedical raises $53 million for Type 1 diabetes care, and Glooko raises $30 million for their management system primarily working with diabetes clinics.

In this episode, Lane Desborough joins Sajeev Saluja to discuss finessing blood sugar monitoring. Lane was the cheif engineer for insulin delivery at Medtronic and chief engineer at Bigfoot Biomedical. He is now pursuing a new idea in automated insulin delivery that is currently in stealth mode.

Today on Health in 2 Point 00, there's been so much movement in digital health funding this week that we have a triple-episode. Bigfoot Biomedical raised $55 million in a Series C, Tictrac raised $7.5 million for employee wellness, Lifestance Health raised a whopping $1.2 billion, Maven acquired Bright Parenting, Higi raised $30 million, Bright.md raised $16.7 million, Tia raises $24 million, Doktor.se raising €45 million, Orbita raised $9 million, Curatio's undisclosed A, Siren raised $11.8 million, 100plus raised $15 million, Ubie raised $18.7 million, Change Healthcare acquired 2 different companies—PDX for $208 million and ERX for $213 million, and special funds by Andreessen Horowitz and Softbank supporting founders of color.

Steel Magnolias is getting reissued in a lot of theaters across the country to celebrate 30 years since the movie’s release. The movie has become a touchstone and a bit of a hot spot for  women, pregnancy and type 1 diabetes. This round table first ran last year as Stacey's local theater was putting on the show; Steele Magnolias was first a play by Robert Harling – based on the true story of his sister’s death then the blockbuster movie. Join the Diabetes Connections Facebook Group!  Melissa Lee, Kerri Sparling & Kyrra Richards are all moms who live with type 1 joined Stacey for this talk about the movie, their experiences in pregnancy and now with their kids. Melissa is the director of community relations for Bigfoot Biomedical, the mother of two children and was diagnosed with type 1 in elementary school. She blogs at Sweetly Voiced. Kerri is an author, advocate and until recently, she wrote SixUntilMe, the wonderful blog that she wrapped up this month. Kerri was diagnosed at age 7 and has two children. Kyyra created and heads up Myabetic – which makes beautiful fashionable bags with diabetes in mind – she was diagnosed as a adult and when we taped this interview last year she had one baby and another on the way. She now has two young children. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.   Last year's episode here (includes some stories about Benny at summer camp - but the Steel Magnolias round table is the same) ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!  ----- Sign up for our newsletter here Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android    

Did you ever wish you had a Geek Squad on call for diabetes tech issues? Like one of the big box store helpers. David Panzirer with the Helmsley Trust wants to make it happen, starting with CGMs. David explains why he thinks this will work, who will pay for it, and shares his story; two of his three children live with type 1. Join the Diabetes Connections Facebook Group!  Plus.. catching up with Bigfoot Biomedical’s Lane Desborough about their subscription model. Stacey also has information about Bigfoot's new agreement with Lilly Diabetes.  And Tell Me Something Good! Going from DKA to IronMan in just one year?! You'll hear Lauren Dahlin's fantastic story ---- 1:30 Stacey welcome includes a bit about our trip to Israel (more here from Stacey's FB Live) 5:30 Interview with David Panzirer Take action - text the word “CGMChamps” to 555-888 or log on to www.cgmchampions.org 35:25 Stacey talks about Lilly & Bigfoot's new announcement 38:45 Interview with Lane Desborough 55:30 Tell Me Something Good all about Lauren who went from DKA to Ironman 58:30 Stacey just attended the JDRF Greater Western Carolinas Summit - contact us if you'd like her to speak at your event  stacey@diabetes-connections.com  ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!  ----- Sign up for our newsletter here Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android 

Stacey talks to Jen Block from Bigfoot Biomedical with a look at why they plan to be more than a pump company, offering help navigating healthcare and a subscription service. Jen is the VP of Medical and Clinical Affairs. She was diagnosed with type 1 her sophomore year in college, during a cross country road trip. Now a Nurse Practitioner and Certified Diabetes Educator, she shares her story and details about Bigfoot. In our Know Better Segment, one of the very first studies about LADA – sometimes called type 1.5. We’ll tell you what researchers learned. And Stacey shares a story about a recent wedding where she made one T1D friend and embarrassed herself trying to track down another.   Join the Facebook Group!  ----- 1:40 Stacey Welcome 4:50 Interview with Bigfoot's Jen Block 49:30 LADA study 52:30 Stacey doesn't have diabetes radar but she is very embarrassing when she thinks she does..   ------ Sign up for our newsletter here Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android 

When you don't see eye to eye with your endo, or any doctor, what are your options? An interesting conversation about getting the most from your health care provider as well as looking at disclosing diabetes at work. John Chaffier has lived with type one for more than 40 years. He has a lot of strong opinions and some hair-raising experiences to share. Learn about remote healthcare options like Integrated Diabetes Services. Article from Consumer Reports on Leaving Your Doctor Plus, a little more on Dexcom’s G6 announcement. In our Know Better segment.. Abbott gives a financial boost to Bigfoot Biomedical.  Join the Diabetes Connections Facebook Group! Find out more about our Alexa skill and please leave a review! ----- 1:15 Stacey welcome, we're out of the studio, sorry for any bad audio 3:00 Interview with John Chaffier 27:00 Dexcom G6 update 29:00 Know Better: Abbott invests in Bigfoot ----- Sign up for our newsletter here Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android   

What do you do when you get bad news? Do you moan and complain about it? Maybe you steel yourself and decide not to let it dominate you and carry on, taking the setbacks in stride. Or maybe, you're one of the group of people who takes that decision even further and resolves to declare war on the obstacles before you. You dedicate your work, energy and resources to not just to overcome those challenges, but to completely transform the situation and experience of others who are facing and will face similar challenges. Considering you’ve self selected into this digital health community, I’m guessing that you’re in one of the two latter groups, and let’s face it, you’re likely in the last group: The group that Unity Stoakes would call the change makers and transformers. People in this group not only refuse to accept the status quo, but go to work to change the way the world works, create new paradigms and shape new ways of thinking. My guest today definitely falls into this group. And I think there’s a super power that comes into play when the challenge that life deals doesn’t just affect us, it’s affects someone we love and care about. Our guest in this episode is Jeffrey Brewer, CEO and Co-founder of Bigfoot Biomedical. He shares his story of when he received the news that his son has Diabetes, and the confusion and despair that followed. He explains how that led to changes in his life and took him down a path that has seen him start Bigfoot Biomedical. He gives insights into the tremendous progress they’ve made in a short space of time and what the future holds for his product, and, importantly, for people with insulin-dependent diabetes around the world. You can get all the show notes from this podcast and even watch a video a video of Jeffrey - just go to digitalhealthtoday.com/47. Learn more about your ad choices. Visit megaphone.fm/adchoices

Join the new Diabetes Connections Facebook Group!  ----- Learn about the Abbott Freestyle Libre, a Flash Glucose Monitoring System recently approved in the US. We talk to Dr. Chris Thomas, the director of biosensor technology for Abbott about what exactly the Libre is, how it works and who it's for.  Plus, Bigfoot Biomedical is now partnering with Abbott to use the LIbre in their automated insulin delivery system. We talk to CEO Jeffrey Brewer to find out how what this means and what's on the horizon for Bigfoot. Good article on the partnership here from DiabetesMine. You'll also hear from Steve Hanley of KNOW Foods. Stacey wanted to speak to him after he donated all the bikes to the riders of Bike Beyond and wound up learning all about this new company. You can read more about KNOW Foods in this Sweet Life column by Kerri Sparling. Stacey also shares her take on overnight school fields trips; Benny recently spent three days away with his school. We also address the closure of Animas, what that means to the podcast, Stacey & her family and to customers. Learn more from Animas here.  ----- 3:00 Stacey talks about Animas 8:00 Stacey talks about Field Trips 15:00 Interview with Chris Thomas, Abbott 33:00 Interview with Jeffrey Brewer, Bigfoot Biomedical 1:19:00 Interview with Steve Hanley, KNOW Foods   ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android  Sign up for our newsletter here

An ailing wife and son forced Bryan Mazlish to hack a cell phone, glucose monitor, and insulin pump to create an artificial pancreas. In this MedtechTalk Podcast, Jeffrey Brewer, CEO and president of Bigfoot Biomedical, explains how he and Mazlish came to form the privately held start-up. Brewer explains how his son’s diagnosis – and at least one near-fatal experience – pushes him forward to ensure Bigfoot leads the class of next-generation devices that may someday come close to creating a cure for this dreaded disease. Learn More about Medtech Talk: https://goo.gl/o6Ue5u

Jeffrey Brewer left the start-up realm to focus on understanding and aiding his young son after a diabetes diagnosis. But a “hack” of a glucose monitor brought him back into the CEO role of Bigfoot Biomedical, a company working to build a networked system of glucose detection and insulin delivery. To Learn more about the Breaking Health Podcast, visit: https://goo.gl/ecYaUL

Bigfoot CEO Jeffrey Brewer is back to talk about the progress of their artificial pancreas and other interesting products. Timelines, progress, goals... we talk about it all. Our Sponsors OmniPod - Try a free no obligation Demo of the worlds only tubeless insulin pump. To get started go to myomnipod.com/juicebox Dexcom - To learn more about the Dexcom Continuous Glucose Monitoring, visit Dexcom.com/Juicebox  The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here. Thank you! show notes Bigfoot is online at BigFootBiomedical.com You can follow Derek on Instagram, Twitter and Facebook Subscribe to the podcast on iTunes today! Android users... The JBP is available on Google Play The Juicebox Podcast is now available on iHeartRadio 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.

Bigfoot Biomedical came on the scene in 2014 determined to change the way companies look at diabetes technology. They've moved forward quickly and are now starting their first clinical trial for their "Smartloop" automated insulin delivery system. Stacey talks to Bigfoot Chief Engineer Lane Desborough about what this system is, what the trial is testing, and how you can find out if you're eligible to enroll. Desborough is also the co-creator of Nightscout, the free, open source CGM remote monitoring system and is credited with coining the term "We are not waiting." Like all four founders of Bigfoot, Desborough has a child with type 1 diabetes.  

01:06 - Scott Hanselman Introduction Twitter GitHub Blog Hanselminutes This Developer's Life 02:23 - Managing Diabetes American Diabetes Association 13:14 - “Closed-Loop” System Dexcom Continuous Glucose Monitoring (CGM) 20:16 - OpenAPS 23:00 - Monitoring 26:37 - The Current State of Systems 28:44 - What can people do now? openaps 34:56 - The Future Bigfoot Biomedical 37:37 - Wearing Devices Scott Hanselman: Hacking Diabetes Picks Reading Papers (Andrew) Diabetes Light (Jaim) Diabetes Light: My holistic journey to health (Facebook) (Jaim) The Essential Prince Reading List (Jaim) Jimmy Jam and Terry Lewis have become synonymous with recording excellence (Jaim) The Primal Blueprint (Chuck) Mark’s Daily Apple (Chuck) Chatting with Prince on AOL in 1999 (Scott)

01:06 - Scott Hanselman Introduction Twitter GitHub Blog Hanselminutes This Developer's Life 02:23 - Managing Diabetes American Diabetes Association 13:14 - “Closed-Loop” System Dexcom Continuous Glucose Monitoring (CGM) 20:16 - OpenAPS 23:00 - Monitoring 26:37 - The Current State of Systems 28:44 - What can people do now? openaps 34:56 - The Future Bigfoot Biomedical 37:37 - Wearing Devices Scott Hanselman: Hacking Diabetes Picks Reading Papers (Andrew) Diabetes Light (Jaim) Diabetes Light: My holistic journey to health (Facebook) (Jaim) The Essential Prince Reading List (Jaim) Jimmy Jam and Terry Lewis have become synonymous with recording excellence (Jaim) The Primal Blueprint (Chuck) Mark’s Daily Apple (Chuck) Chatting with Prince on AOL in 1999 (Scott)

Melissa Lee joins me this week to discuss the process of creating a song parody, her time serving as Interim Executive Director of Diabetes Hands Foundation, writing for A Sweet Life, and her perspective on Bigfoot Biomedical (her husband works there, by the way). Learn more about the Melissa's #dparodies at sweetlyvoiced.com, and A Sweet Life at asweetlife.org, and Bigfoot Biomedical at bigfootbiomedical.com. Follow Melissa on Twitter @sweetlyvoiced. Run Time - 1:09:26 Send your feedback to feedback@justtalkingpodcast.com.

Our Sponsors OmniPod - Try a free no obligation Demo of the worlds only tubeless insulin pump. To get started go to myomnipod.com/juicebox   Bigfoot Biomedical is a company dedicated to the development of a closed loop insulin delivery system. Founded and run by the parents and loved ones of people living with type 1 diabetes... this company has a personal investment in getting to market as soon as possible. This episode is with Jeffrey Brewer, former CEO of the JDRF and current CEO of Bigfoot. The future isn't so far away.   Show Notes Learn more about Bigfoot at their blog. Subscribe to the podcast on iTunes today! 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.

In 2013, Bryan Mazlish created a home-made artificial pancreas system for use by his wife and son, both of whom have type 1 diabetes. Because Mazlish preferred to stay anonymous, a reporter dubbed him "Bigfoot." In 2015, Mazlish went public and partnered with two others to create Bigfoot Biomedical. Their goal is to bring this technology & other products to market in order to improve the lives of people with T1D. In our Community Connection, Stacey finds out about Hockey Fights T1D, a new JDRF fundraiser in upstate NY sparked by a two year old's diagnosis.

This week I spoke with Jeffrey Brewer about weather in the Bay Area, his work at Kickstart, and his advocacy efforts within the JDRF including his stint as their CEO. Most importantly we discuss Bigfoot Biomedical, its origins, and its aspirations. Follow Jeffrey on Twitter @Bigfoot_CEO, @BigfootBiomed and bigfootbiomedical.com. Run Time - 57:59 Send your feedback to feedback@justtalkingpodcast.com.

Stacey talks to Jeffrey Brewer, former head of JDRF, now CEO of Bigfoot Biomedical. We’ll find out how he hopes to simplify diabetes management through technology and the story behind the Bigfoot name. Stacey also hears about a teenager’s first trip away from home and how a diabetes connection on the road made a big difference. Plus, what to do this summer to make school better for your child with diabetes this fall.