Podcast appearances and mentions of jake leach

For the first time, you can buy a continuous glucose monitor over the counter, no prescription needed. This summer we went from no CGMs available this way, to now having two. This week we're talking about the Dexcom Stelo with the company's COO Jake Leach. We'll talk about Stelo and get an update on G7 features including Dexcom's plans to address concerns over Geofencing, and issues that can potentially arise if you travel outside your home country. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: Dexcom CGM is worn in space, two over-the-counter CGMs are now available, a large new study looks at potential dietary causes of type 1, and researchers are looking at a gel version of GLP-1 medications. Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Astronauts on the Polaris-Dawn mission are wearing the Dexcom G6 CGM. Polaris Dawn launched this week with astronauts wearing the G6 to better understand the effects of spaceflight on human health. The crew intends to conduct research to advance human health on Earth and the understanding of health during long-duration spaceflights. “This health research-driven mission marks another first for Dexcom, with our industry-leading CGMs being worn by astronauts in outer space,” said Jake Leach, EVP and COO at Dexcom. “We are thrilled to play a role in building a future where people with diabetes are empowered to accomplish anything they set their minds to–including the possibility of exploring outer space–without being held back by their condition.” Over five days in space, the Polaris Dawn crew plans to conduct around 40 scientific experiments. That includes several aimed at better understanding the effects of spaceflight on glucose health. Labront, a platform assisting health researchers in collecting and analyzing physiological data, is collaborating with Dexcom. It plans to provide advanced analytics for the data collected by the crew.   According to a news release, the mission expects to explore how microgravity, fluid shifts, and blood flow restriction exercises impact glucose regulation. https://www.drugdeliverybusiness.com/dexcom-cgm-outer-space-polaris-dawn/ XX There are now two OTC CGMs.. Dexcom launched Stelo a few weeks ago and now Abbott says Lingo is for sale. They're both available on the companies' websites, cost about the same, but you can opt to buy only one Lingo where Stelo comes in pairs. Lingo is meant for people without diabetes – it's a health bio sensor. Abbott has another CGM called Libre Rio meant for people with type 2 who don't take insulin. Not a lot of details about what the real difference are here – likely just in the software – No word on when Rio will be available. https://www.cnbc.com/2024/09/05/-abbott-launches-its-first-over-the-counter-continuous-glucose-monitor-in-the-us.html XX Warning about flying with an insulin pump – And I want to be clear here because I'm sure you'll see some scary headlines. This is really about pressure emergencies in planes. For the study, researchers tested 26 insulin pumps in a hypobaric chamber programmed to mimic the atmospheric changes during a normal commercial airline flight. “The drop in cabin pressure during ascent may lead to a slight increase in insulin delivery as a result of the formation of air bubbles which displace excess insulin out of the cartridge,” Fan said in a meeting news release. “A slight reduction in insulin delivery is also possible during descent as the increasing air pressure dissolves the air bubbles, sucking insulin back into the pump.” People on insulin pumps could be in real trouble in the event of rapid decompression of the cabin at altitude, researchers said. In that case, the pumps could deliver an insulin overdose -- dropping blood sugar levels so much that there's a significant risk of hypoglycemia, results show. These researchers recommend disconnecting and reconnect at take off and landing, but that's not going to help if there is emergency rapid decompression. As always, be prepared with emergency glucagon and low snacks and supplies. https://www.healthday.com/health-news/diabetes/flying-could-upset-insulin-pump-function-for-type-1-diabetics XX Lilly moves forward with it's version of once weekly basal insulin. Clinical trials show it can help control both Type 1 and Type 2 diabetes as well as daily basal injections do. However, in those with type 1 diabetes, there was an increased risk for hypoglycemia.  This is the same issue with Novo Nordisk's Awiqli insulin – approved in Canada but not in the United States. https://www.upi.com/Health_News/2024/09/11/weekly-insulin-injections-effective-diabetes-weekly/8711726068680/ https://www.medscape.com/viewarticle/once-weekly-insulin-looks-good-t2d-risk-seen-t1d-2024a1000gh8 XX Eating what seems like really healthy foods could be associated with a higher risk of developing type 1 diabetes. New study shows that eating fruit, oats and rye in childhood is associated with a higher risk of developing type 1 diabetes (T1D). Eating berries, however, is linked to lower odds of developing the condition. What triggers the immune system's attack is unknown but is thought to involve a combination of a genetic predisposition and an environmental trigger such as a virus or foodstuff. T1D, the most common form of diabetes in children, is increasing worldwide. The number of cases worldwide is projected to double in just 20 years, from 8.4 million in 2021 to 17.4 million by 2040. Finland has the highest incidence of T1D globally, with 52.2 cases per 100,000 children under the age of 15 – more than five times higher than in the 1950s. 5,674 children (3,010 boys and 2,664 girls) with genetic susceptibility to T1D were followed from birth to the age of six. Food records completed by their parents repeatedly from the age of three months to 6 years provided information on the entire diet.   The 34 food groups covered the entire diet and, when they were all factored in, several foods were associated with a higher risk of developing T1D.   To the best of our knowledge, this is the first time a child's entire diet has been considered at the same time." The results show that the more fruit, oats or rye children ate, the more their risk of T1D increased. In contrast, eating strawberries, blueberries, lingonberries, raspberries, blackcurrants and other berries appeared to provide protection against T1D. The more berries a child ate, the less likely they were to develop T1D. Oats, bananas, fermented dairy products (such as yogurts) and wheat were associated with an increased risk of islet autoimmunity, whereas cruciferous vegetables, such as broccoli, cauliflower and cabbage, were associated with decreased risk. It is, however, too early to make any dietary recommendations. The researchers are quick to point out that they don't really know the “why” here. Could be the food itself, could be pesticides, and until the results are replicated they urge parents not to change their child's diet. https://www.news-medical.net/news/20240909/Eating-fruit-oats-and-rye-in-childhood-may-increase-type-1-diabetes-risk.aspx XX Researchers in France have developed a once-a-month hydrogel-based delivery system for semaglutide, significantly simplifying diabetes and weight management Semaglutide, marketed as Ozempic, Rybelsus, and Wegovy, is a GLP-1 receptor agonist that helps to regulate blood sugar levels and promote weight loss. This medication is especially effective in managing type 2 diabetes and is available in both injectable and oral forms. Semaglutide enhances the body's natural ability to control blood glucose and reduce appetite, providing a dual approach to treatment.     The new hydrogel delivery platform uses two innovative degradable polymers that are chemically bound to one another to form a gel, but allow slow, sustained release of soluble peptides over 1 to 3 months. How do you slow release a gel? With an injection. It goes under the skin. This is still in animal studies, so we're a ways off from human clinical trials. https://scitechdaily.com/new-semaglutide-hydrogel-say-goodbye-to-weekly-shots-for-diabetes-and-weight-loss/ XX   Edgepark Commercial XX   Embecta has received clearance from the Food and Drug Administration for its first insulin patch pump. The device can be used by people with Type 1 or Type 2 diabetes and worn for up to three days. It includes a 300-unit insulin reservoir. Embecta said Tuesday it plans to develop a closed-loop version of the pump for automated insulin dosing that it will submit to the FDA in the future using the Tidepool Loop algorithm. Earlier this summer, Insulet received FDA clearance to offer its Omnipod 5 pump to people with Type 2 diabetes. Diabetes tech firms have focused on Type 2 in recent years as insurance coverage improves. https://www.medtechdive.com/news/embecta-gets-fda-nod-for-insulin-patch-pump/725904/ XX An artificial intelligence (AI)–driven voice algorithm showed "excellent agreement" with the American Diabetes Association (ADA) risk test in detecting adults with type 2 diabetes (T2D), research presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting revealed.   The AI model detected T2D with 66% accuracy among women and 71% in men, and there was 93% agreement with the questionnaire-based ADA risk score, demonstrating comparable performance between voice analysis and an accepted screening tool.   The Colive Voice project includes volunteers from all over the world; however, the current study was restricted to adults from the United States, both with and without T2D, "This first proof of concept was limited to English speakers, and further research will need to enroll more diverse populations, in terms of languages and sociodemographic background," he said. "This study represents a first step toward using voice analysis as a first-line, highly scalable T2D screening strategy," the authors concluded. "The next studies will have to demonstrate the robustness of our approach in diverse populations and also include people living with prediabetes," Fagherazzi said. "If proven reliable, we expect such technology to be available in the next 5-10 years. Then, it could be deployed easily at scale in millions of smartphones worldwide and reduce undiagnosed diabetes cases." https://www.medscape.com/viewarticle/ai-voice-analysis-diabetes-screening-shows-promise-2024a1000ggw XX Join us again soon!

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

Dexcom EVP Jake Leach returns to answer listern questions about G7 and fill us in on the new Dexcom Stelo. CONTOUR NextGen smart meter and CONTOUR DIABETES app Learn about the Dexcom G6 and G7 CGM Go tubeless with Omnipod 5 or Omnipod DASH  Get your supplies from US MED  or call 888-721-1514 Learn about Touched By Type 1 This BetterHelp link saves 10% on your first month of therapy Try delicious AG1 - Drink AG1.com/Juicebox Use code JUICEBOX to save 40% at Cozy Earth  Get Gvoke HypoPen Take the T1DExchange survey NEW SPONSOR Eversense CGM A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! 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 Apple Podcasts. Thank you! The Juicebox Podcast is not a charitable organization.

This week, we get an update from Dexcom. Chief Operating Officer Jake Leach talks about their soon to be launched CGM for people with type 2. It's called Stelo and it's front of the FDA right now. We also answer a lot of your questions about G6, G7, interoperability, connectivity and what's next. Some information on Stelo: https://diatribe.org/new-dexcom-cgm-people-type-2-diabetes-not-using-insulin Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode summary (AI generated) A new CGM product for people with type 2 diabetes. Stacey Simms and Jake Leach discuss a new CGM product for people with type 2 diabetes, currently under FDA review. Stello extends sensor wear to 15 days while maintaining accuracy and reliability for CGM users, regardless of insulin titration. Stello aims to help people with diabetes understand how food impacts their glucose levels through a simple and user-friendly CGM device. CGM for type 2 diabetes and payer coverage. Jake Leach explains how the new CGM product will notify users of high glucose levels without alerting them to take insulin, providing valuable insights into food and diet impact on glucose levels. Stacey Simms seeks more detail on the product and its potential for long-term use, expressing interest in education and training for users to fully understand and benefit from the technology. Stacey Simms asks Jake Leach about the continuous use of CGMs, and Jake explains that the product is designed to be engaging and provide value continuously, with users learning and improving their diabetes management over time. Jake also mentions that the company is working with payers to expand coverage for CGMs beyond Medicare, as it can be a challenge for people without insulin use. CGM access, naming, and interoperability. Stello is a cache pay product starting off affordable and competitive, with potential for reimbursement as evidence of benefits grows. Jake Leach: Excited about new brand for Dexcom, with different design for new population, but still with expected performance reliability. Jake Leach: G6 and G7 interoperability is a focus, with Omni pod integration and launch timing controlled by Dexcom. G7 features and enhancements. Jake Leach: Enhancements made to Bluetooth connectivity on G7 device, now available across channels and geographies. Jake Leach discusses the company's focus on improving sensor reliability and user satisfaction through ongoing software development and user feedback. The company prioritizes features based on user feedback and releases them in a timely manner, with a dedicated team working on the Apple Watch feature. Dexcom's CGM technology and its potential for more widespread access. Jake Leach and Stacey Simms discuss the evolution of G7, including its smaller size and reduced environmental footprint. The company is working on a direct-to-watch submission and has validated alerts and alarms on the watch platform. Dexcom aims to provide best CGM for users' pump systems, partnering with multiple companies globally. Jake Leach is passionate about expanding access to CGM technology for people with diabetes worldwide.  

Jake Leach, Chief Operating Officer at Dexcom Today, Jake is the COO at one of the top medical technology companies in the world. But, before he became responsible for all things product, research and development, and the like, Jake got his start in the industry as an intern. We explore Jake's career journey, including how he learned to apply his studies as an electrical engineer to the health sciences and what gave him the confidence to take a chance on a startup called Dexcom early in his career. Jake also shares his top tips for career growth and leadership. Notably, he explains why one of the most impactful things for his career growth was when he turned down a high-profile leadership role. http://blindap.onelink.me/ttCg/3pz372ts

Dexcom's Chief Operating Officer Jake Leach talks to me about G6, G7, trends in CGM, what the company has its eye on next and answers a lot of your questions. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.   Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com    

Dexcom COO Jake Leach is here to talk about G7, G6, Type 2 and answer listener questions. This BetterHelp link saves 10% on your first month of therapy Try delicious AG1 - Drink AG1.com/Juicebox Use code JUICEBOX to save 35% at Cozy Earth  Get the Gvoke HypoPen CONTOUR NEXTONE smart meter and CONTOUR DIABETES app Learn about the Dexcom G6 and G7 CGM Go tubeless with Omnipod 5 or Omnipod DASH  Get your supplies from US MED  or call 888-721-1514 Learn about Touched By Type 1 Take the T1DExchange survey A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Follow Scott on Social Media @ArdensDay @JuiceboxPodcast Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on iTunes. Thank you! Arden's Day and The Juicebox Podcast are not charitable organizations.  

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: after a long wait, the FDA approves Medtronics 780G and lifts their warning letter, Omnipod GO for people with type 2 gets approved, a look at insulin in pill form, a new way to treat overnight low blood sugars and lots 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   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 the T1D Exchange, make your voice heard and drive research that matters XX Buckle up there is a LOT going on XX Medtronic's Minimed 780G AID system gets FDA approval. This is for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders on May 15, 2023. Users of the current MiniMed 770G will be eligible for free remote software upgrades. The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the UK since 2021. The biggest difference from other systems is that it can automatically administer bolus correction insulin doses every 5 minutes. It will also automatically adjust basal insulin The insulin pump's infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL. In the pivotal US trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia. https://www.medscape.com/viewarticle/991091 XX U.S. Food and Drug Administration (FDA) lifted Medtronic's warning letter sent in December 2021. The resolution of the warning letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems. All regulatory restrictions associated with the warning letter have been resolved. https://finance.yahoo.com/news/medtronic-diabetes-resolves-warning-letter-203000188.html XX FDA also approved Omipod GO, for people with type 2 who take daily injections of long acting insulin. Insulet says “Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes” Omnipod GO is a standalone system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It's tubeless and waterproof just like a regular Omnipod but it's offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. It has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®. The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. If a patient becomes insulin-intensive, meaning they require both basal and bolus insulin, the transition to another Omnipod product would be seamless. Omnipod GO will have its US launch sometime next year. https://www.businesswire.com/news/home/20230424006026/en/Insulet-Announces-FDA-Clearance-of-Omnipod-GO%E2%84%A2-a-First-of-its-Kind-Basal-Only-Insulin-Pod-Further-Simplifying-Life-for-People-with-Type-2-Diabetes XX Senseonics says the first pediatric study participant has received an Eversense 365-day CGM insertion. The E3 180 day implantable CGM got FDA approval in February last year. Dr. Francine Kaufman, Senseonics CMO, said expanding to a pediatric population represents a “priority” for the company. Positive results could further extend the company's reach across the global diabetes community, she added. The company also intends to utilize study data to submit for an integrated CGM (iCGM) designation in 2023. Senseonics holds an FDA investigational device exemption (IDE) to expand the trial to pediatric patients. These patients — between 14 and 18 years old — first enrolled in the second quarter of 2023. https://www.drugdeliverybusiness.com/senseonics-first-pediatric-cgm-insertions/ XX Baqsimi gets a new home. Amphastar Pharmaceuticals is buying the Glucagon nasal spray from Lilly in a deal worth up to $1.08 billion dollars. Launched in 2019, Baqsimi saw worldwide sales worth $139.3 million in 2022, the companies said. You may remember that Lilly had acquired Baqsimi from Locemia Solutions in 2015. The drug has an active compound glucagon, a form of a hormone produced in the pancreas that stimulates glucose production https://www.reuters.com/markets/deals/eli-lilly-sell-low-blood-sugar-drug-amphastar-2023-04-24/ XX The FDA recently cleared a new experimental drug for type 1 diabetes to begin a phase 2 clinical trial. If approved, the drug would be the first therapy to specifically address low blood sugar at night. We've talked about this.. Zucara Therapeutics is testing an oral medication currently known as ZT-01 will attempt to restore the body's natural ability to respond to low blood sugar levels. Researchers will evaluate the ability of the drug to blunt hypoglycemia caused by insulin in type 1 diabetes. This phase 2 clinical trial follows positive results from the company's earlier phase 1 study which included 18 participants with type 1 diabetes who received the treatment. Of these 18, 16 (89%) had a meaningful increase in glucagon production after being given ZT-01, with no serious health events during the trial. https://diatribe.org/drug-prevent-nighttime-lows-approved-enter-clinical-trials XX 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. XX Australian scientists have designed a new way to swallow insulin, in a pill form. The design also has potential uses for delivering other protein drugs, such as antibiotics and cancer treatments. Insulin is made of smaller versions of proteins called peptides. Previous attempts to develop an orally administered insulin have found that the severe pH levels in the gastrointestinal tract degrade the peptides, causing the drug to lose its function. To get around this problem, the scientists encapsulated the insulin in a lipid-based nanomaterial placed inside an enteric capsule. In animal studies, long acting insulin was absorbed better than fast acting. They say long way to go, but an interesting start. https://newatlas.com/medical/new-insulin-capsule-game-changing-diabetics/ XX A new proof of principle study demonstrates the accuracy of Know Labs' proprietary Bio-RFID™ sensor in quantifying different analytes in vitro, proving a 100% accuracy rate in these tests. The full study is currently undergoing the peer-review publishing process. “Proof-of-principle studies are critical in demonstrating Bio-RFID's accuracy for non-invasive methods of medical diagnostics. This was an essential step toward achieving our goal of delivering the first FDA-cleared, truly non-invasive glucose monitoring device to the market” Know Labs' technology platform, Bio-RFID, uses electromagnetic energy in the form of radio waves to non-invasively capture molecular signatures, which can be converted into physiologically meaningful information and insights. While the technology is proven to accurately measure several analytes inside and outside the body, the first application of this technology is aimed at non-invasive glucose monitoring. This study did not include people but researchers say it's an important step on the way. https://www.businesswire.com/news/home/20230421005095/en/Know-Labs-Demonstrates-Accuracy-of-Non-Invasive-Bio-RFID-Technology-with-Proof-of-Principle-Study XX Moms Night Out – new cities include Providence, RI, Frisco, TX and Charlotte NC. more info here XX On the podcast next week.. Dexom's Jake Leach brings us up to date on some G7 updates as well as new Medicare coverage for people with type 2. Last week's episode was with the first US commercial pilot with type 1, Pietro Marsala. . That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Dexcom's G7 has been available in the US for less than two weeks, but the company continues to look ahead. Part of the future? Their Type Zero group – which created Tandem's Control IQ – is working on a truly closed loop system. Chief Operating Officer Jake Leach spoke to Stacey from the recent ATTD Conference. Of course we also asked a bunch of your G7 questions and had a more in-depth discussion about CGM monitoring for people without diabetes. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. 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    

This week.. after a year of deliberations, the US FDA approves the newest product from Dexcom, the G7. This is a much smaller device, with all-in-one sensor and transmitter, shorter warm up time and many more new features. Stacey talks with Dexcom's Chief Operating Officer Jake Leach. They do a lighting round of questions to learn more about what was – and was NOT – approved here. It's not exactly what's already on the market in Europe.. and we look ahead to what's next. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Previous episodes on the G7: https://diabetes-connections.com/?s=g7 Watch the interview on our YouTube channel: https://www.youtube.com/@diabetesconnections Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

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

We're taking a look at the design decisions that go into diabetes technology, specifically Dexcom's G7. Beyond the accuracy and interoperability we all want, they also look at things like dexterity, feel and hand strength. Alex Diener is Dexcom's Senior Director of Global Product Design. He lives with type 1 and he shared a lot of the behind the scenes thought process that's gone into the design of the G7 sensor and transmitter and the apps that go along with it. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Halloween webinar for parents: https://us02web.zoom.us/webinar/register/WN_0Xaaj9hoR-u96Kxm-OjfSQ Moms' Night Out event: https://diabetes-connections.com/diabetes-connections-presents-moms-night-out/ Check out Stacey's books and use promo code "Spooky" to save $3! More about Dexcom: Our interviews with CEO Kevin Sayer: https://diabetes-connections.com/?s=sayer Our interviews with COO Jake Leach: https://diabetes-connections.com/?s=leach Join the Diabetes Connections Facebook Group! Sign up for our newsletter here Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

Dexcom's G7 is still not approved in the United States, but it's in limited release in Europe. This week, friend of the show Kamil Armacki, better known as Nerdabetic, interviews Dexcom's Chief Operating Officer, Jake Leach. Find more about Kamil over at his amazing YouTube Channel here: https://www.youtube.com/c/nerdabetic 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 Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM*

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

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

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

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

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

Top stories this week include: a new adjunct therapy is being tested for type 1, Dexcom and Garmin will officially work together (no more DIY needed), once weekly basal insulin study, can psychedelic drugs prevent type 2?! and Australia bets on Rugby for diabetes education Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode transcription below:  Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and I am on location this week. I'm at the She Podcasts LIVE conference.. but the news doesn't wait. So.. 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 – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more if you want, on your own schedule. XX In the News is brought to you by Real Good Foods! Find their breakfast line and all of their great products in your local grocery store, Target or Costco. XX Our top story.. There's a lot of buzz these days around adjunct therapy for diabetes.. basically another treatment along with insulin. Earlier this year, a drug so far just named TTP-399 got FDA breakthrough therapy approval. A new study shows it works well to keep people with type 1 out of DKA. This was small study, 23 people. They found that TTP-399 can help lower blood glucose without increasing the risk of DKA. It's important because other adjunct therapy.. such as S-G-L-T-2 inhibitors do help lower blood glucose, but the FDA has said they cause too much of a risk of DKA in people with type 1. Those are brand names like Invokana and Jardiance. Pivotal trials of TTP-399 begin later this year. https://www.biospace.com/article/vtv-therapeutics-type-1-diabetes-drug-shows-promise/ XX New partnership announced today - Dexcom and Garmin. You will still need your phone.. I knew you were going to ask.. but with the new Dexcom Connect IQ apps you can now see your Dexcom G6 info on your compatible Garmin smartwatch or cycling computer. Jake Leach, chief technology officer at Dexcom says.. Garmin is the first partner to connect through the real-time API, which we told you about a few months back. Basically, you'll be seeing more connectivity without having to use a third party, community sourced work around which a lot of people do now. The name here is interesting, right? Connect IQ, very similar to Tandem's Control IQ. But since Dexcom owns a bit of Tandem, maybe that's no coincidence. I've requested an interview with Dexcom so maybe we'll find out. garmin.com/newsroom, email media.relations@garmin.com, or follow us at facebook.com/garmin, twitter.com/garminnews, instagram.com/garmin, youtube.com/garmin or linkedin.com/company/garmin. XX New study about time in range, hybrid closed loop systems and faster insulins. The headline here is that using Fiasp with the Medtronic 670g system resulted in greater time in range. How much? The Fiasp group spend 82 point 3 percent time in range.. the Novolog group spent 79.6 percent time in range. This was over 17 weeks and the participants mostly bolused AT meal times, not before, no prebolusing. The researchers echo what I was going to say here, quote – “While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in time in range of 1.9%.” So just a heads up if you see headlines screaming about how much faster Fiasp is because of this study. https://www.endocrinologyadvisor.com/home/topics/diabetes/type-1-diabetes/fast-acting-insulin-aspart-versus-insulin-aspart-closed-loop-type-1-diabetes/ XX People who have tried a psychedelic drug at least once in their lifetime have lower odds of heart disease and diabetes. This is a University of Oxford study published in Scientific Reports. These researchers examined data from more than 375-thousand Americans who had taken part in an annual survey sponsored by the U.S. Department of Health and Human Services. Participants reported whether they had ever used the classic psychedelic substances including LSD, mescaline, peyote or psilocybin. They also reported whether they had been diagnosed with heart disease or diabetes in the past year. The researchers found that the prevalence of both conditions was lower among psychedelic users. While no one is recommending you start taking mushrooms to avoid diabetes.. there's a growing push to start serious research to investigate the link between psychedelics and cardio-metabolic health. https://www.psypost.org/2021/10/psychedelic-use-associated-with-lower-odds-of-heart-disease-and-diabetes-study-finds-61958 XX Update on the once a week basal insulin I've been reporting on for a while.. both Lilly and Novo Nordisk are testing their own version of this.. this most recent study looks at the Lilly version called Tirzepatide. These researchers found it to be safe and effective with lower rates of hypoglycemia and slightly lower A1Cs than daily basals like Lantus or Tresiba. Lots of studies ongoing here, for both brands of potential once a week dosing, including a large phase 2 program that includes people with type 1. https://www.healio.com/news/endocrinology/20211012/novel-onceweekly-basal-insulin-safe-effective-in-type-2-diabetes XX More to come, including how rugby and diabetes education may go together.. But first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Real Good Foods. Where the mission is Be Real Good They make nutritious foods— grain free, high in protein, never added sugar and from real ingredients—we really like their breakfast line.. although Benny rarely eats the waffles or breakfast sandwiches for breakfast.. it's usually after school or late night. Ugh.. do your teens eat breakfast? You can buy Real Good Foods online or find a store near you with their locator right on the website. I'll put a link in the FB comments and as always at d-c dot com. Back to the news… -- Getting out of the doctor's office and into something that people can actually relate to.. Diabetes Australia is using rugby to teach men about the risks of type 2 diabetes. League Fans in Training (League-FIT) is based on a Scottish initiative that used football teams to deliver exercise and nutritional advice to overweight and obese men. The program includes education and goal setting and a rugby league-based exercise session, delivered by coaches and some of the club's players. What I really like about this is that -from what I can tell - they're focusing on small changes and not telling these guys to give up everything they like to eat and drink or that they have to become professional players to get a little bit more fit. Imagine if NFL players had a clinic for fans to come and learn a little bit about fitness and nutrition? Again, not to be pros.. just to live a little better and lower risks of type 2. https://www.diabetesaustralia.com.au/news -- On Diabetes Connections this week, we're talking to a mom with type 1 who has had two children during the pandemic. One last summer and the other just a few days before our interview! That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

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

Digging deeper into recent news from and about Dexcom. Stacey talks to Chief Technology Officer Jake Leach about the news that competitor Abbott has received approval for it's Libre 2 CGM. What does that mean for the marketplace? She also asks Jake about G6 sensor issues, data gathering and more. Check out Stacey's new book: The World's Worst Diabetes Mom! Dexcom statement on data and privacy: Patient safety is a top priority at Dexcom, and we design our products to be as safe and secure as possible, as the data that comes into our system from CGM devices is extremely important for patients and physicians in understanding and improving diabetes management. Dexcom works with government agencies, industry partners and security researchers to apply current best security practices for medical devices to help ensure the integrity and availability of our systems. Our terms of data use are laid out for patients to consent or opt-out when they first set up a Dexcom account, so they know exactly how their data could be used and who will have access to it. In order for healthcare providers to access patient data, each patient must approve the sharing of their data to the healthcare provider through the CLARITY app. Another way patients can opt-out of sharing any of their data is by using the dedicated Dexcom receiver to view their glucose levels instead of a smart device. 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: Stacey Simms  0:00 Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.   Announcer  0:16 This is Diabetes Connections with Stacey Simms.   Stacey Simms  0:22 Welcome to a bonus episode of Diabetes Connections. So glad to have you along as always. A bit of an unusual situation this week in the very last episode, and hopefully you've heard it. I spoke to Dexcom CEO Kevin Sayer. we taped that episode before the ADA conference actually took place. You know, the time shifting nature of podcasting. we taped these interviews ahead of time and then a couple of days or a week later, generally, the interviews air. A a couple of days after taping that interview, the FDA approved Abbott's Libre2 and this is a different CGM is able to continue transmit glucose data every minute. And users can now set the system to send alarms when their glucose is too high or too low. And previously, you had to scan the sensor in order to get any kind of glucose reads. So that is a big change, and frankly, more direct competition to Dexcom. I have reached out to Abbott in the hopes of learning more and asking them any questions that you may have Dexcom though, immediately reached back out to me and asked if we wanted to talk more about CGM and how they stack up in the marketplace. Now, I am not going to pass up the opportunity to ask more of your questions. And that's why we have sort of a Dexcom double feature this week. My usual disclaimer Dexcom as you have heard, and longtime listeners know Dexcom is a sponsor of this show. That means they pay me to have a commercial in the show. That sponsorship gets them a commercial, it does not get them any kind of approval over content. And so what does that mean? It means I don't send them all the questions. I have of time, we don't plan out what we're going to say. I hope you know, as you've listened that I don't hold back on questions and criticism from them. But we do have that relationship. And it's really important that you you know it right because we were doing news interviews here. And this interview is with Dexcom CTO, Jake Leach. I will link up more information at the episode homepage. And as always, there is a transcript. So here is my interview with Dexcom’s chief technical officer. Jake, thank you for jumping on and spending some time with me and my listeners. We always appreciate learning more about what's going on at Dexcom. So thank you.   Jake Leach  2:36 It's a pleasure to be here. Stacey. Thanks for having me.   Stacey Simms  2:38 Absolutely. So I just talked to Kevin Sayer. We did kind of a high level, you know what's new, what's next? How are things going? Talking about the G7? It he's of changes that have happened to the G6 COVID delays, that sort of thing. My listeners had a bunch of questions as this is the backdrop of course of the Libre news that came out Abbott's Libre 2 have got approval for use of the United States. The number one question that my listeners had was, can they talk about the price difference? I don't know if that's a CTO level question.   Jake Leach  3:11 Yeah, as much as you know, I'm involved in it. We basically, when we think about the cost of the product, the most important thing to be thinking about is making sure people have access to it. So insurance coverage, we feel really good about the fact that 98% of the private insurance companies do cover the product, as well as Medicare started covers it. And in states, many Medicaid systems do also cover the product as insurance. That's where we focus our time is really on on that. And we very few of our customers actually pay cash for the product. The vast majority of everybody gets it through insurance coverage.   Stacey Simms  3:48 When I look at the Libre, and full disclosure here, my husband has type two diabetes and he uses the Libre and Benny my son has used the Dexcom since 2013. Now, wow, yeah, it's funny to think about how much time has gone by. But one of the things I look at with the G7 coming and the you know, the bit that we know about it is that it will be much more like the Libre in terms of the sensor and transmitter in one. Can you speak to that in terms of the G7 in terms of size, insertion, that sort of thing?   Jake Leach  4:25 Yeah, so the G7 is, as you pointed out as an integrated sensor all in one, so it's the wearable device that goes on the body includes both the sensor, the transmitter, as well as the electronics inside the wearable that are both monitoring the center and then taking that signal and sending it via Bluetooth to the different integrated display devices whether that's a mobile phone, so a smartphone with an app on it, Android or iOS, or a insulin pump for automated insulin delivery systems. Other display devices, we have our receiver that is our proprietary handheld, some people really like that as their way to access the information. So our goal is to make it as interoperable as possible, which is one of the key important points about IC GM is that it's interoperable device   Stacey Simms  5:16 you And with that, I always get hung up on it. Because when I heard about interoperability A few years ago, in my head, it seemed like, Okay, well, I could switch out my pump, or I could switch out my sensor, I could use a different brand with this thing and kind of mix and match. And of course, insurance for most of us is the biggest problem for getting different devices. But it doesn't really work like that, does it? I mean, if a Dexcom g seven works with say, Omnipod five horizon, and with a T slim X to control IQ, people aren't really going to be able to just switch out devices like that and use the same sensor, are they?   Jake Leach  5:51 Yeah, as usual, it's more complicated as you look at it under the hood. But the key thing about the integration is that systems have to be designed To be able to be integrated. And so one of the big moves that we made when we transitioned between Gen four, and Gen five, and then subsequently Gen six, and as well as Gen seven, we moved to Bluetooth technology, which is a much more readily available technology within the display devices. So we moved to that. And when we did that, we designed an architecture that the intelligence of the system is all on the the wearable. So all the glucose calculations, all the information that you need is actually on the little transmitter device in G6, and will be in G seven as well. And so that is the device that can be accessed by multiple displays. If you think about it, you can use your mobile phone and the whole share feature that comes along with our mobile system, the remote monitoring feature, you can use that and at the same time, you can use a tandem controller to pump doing automated insulin delivery. And so the system is really designed to have that type of integration where you've got the right information in the right places and makes it interoperable. The systems have to be designed To be connected, for example, horizon five Omnipod five, the system that is in development by insolate is being designed to be integrated with both G6, that's what they're doing their studies with as well as G seven. So you have to do the design work and do the testing to ensure that it operates safely. But interoperability is a great thing. But it isn't as simple as just pulling and pulling everything it has to be designed and tested.   Stacey Simms  7:22 Yeah, it was interesting. I in my head, I always had it as well, this, you know, I can mix and match, I can figure out what I want. But when I talk to technical people, they always kind of smile at that because they understand more of the intricacies, I think of what it takes within the technology to make that kind of stuff happen. Whereas as the user, I just want to hokey pokey it around and use what I want. But we'll see as it goes down the road. Some other G7 basics that my listeners asked was, will the G7 have a shorter warm up and does it have a lower MARD? Is it more accurate than G6?   Jake Leach  7:55 Great questions. The warm up time is designed to be shorter than g6. And so we're As we're landing exactly how much shorter it's going to be, but it's definitely going to be a faster warmup. Also, the mard is the average difference between the sensor and the reference measurements that we measured the performance of the device and so on. That way, we want to ensure that we hit those iCGM standards. And so I think G7 definitely has the opportunity to perform better, but it definitely will meet those CGM standards, which are rigorous and important to ensure the product performs accurately throughout its life.   Stacey Simms  8:30 Can you give me a hint on the warm up? Is it going to be more an hour and 45 minutes or more?   Jake Leach  8:35 No, no, no, it's gonna be It'll be an hour or less.   Stacey Simms  8:40 You know, just had to double check on that.   Jake Leach  8:42 Yeah, no games there. We're just we're still trying to dial in exactly what's going to be to ensure we you know, the system has to be accurate. Second, it starts up but we do value short warmup time because we know how important it is when you know you're without the sensor data for that warmup period. So you want to make sure it starts up as fast as possible.   Stacey Simms  8:59 Yeah, it's interesting too. Because I'm probably an outlier but previous to we use the control IQ system with tandem previous to using that the two hour warmup really didn't bother me too much. I mean, it was only two hours especially if you came from like we did seven years with no CGM. It's really did not seem to be that big a deal. But now that we're using this algorithm, and the pump relies on the Dexcom data, two hours just seems like way too long to be without it.   Jake Leach  9:27 I agree. Really interesting.   Stacey Simms  9:29 Speaking of wear time, we've been very fortunate. Again, as I said, we've used Dexcom for a long time we do not really have a lot of issues knock on wood with it. He's of sensitivity which Kevin mentioned in his in our interview together, we went over that, but also with where time, but a lot of my listeners wanted me to ask if you are really checking into the people who can and there are many who can never seem to make it to 10 days on a sensor. Right who really was it whether it's because they have a young  child or the body chemistry for whatever reason, it does seem to be an issue that many people can't get the full life out of a sensor.   Jake Leach  10:07 Can you address that? I know you're looking at it.   Jake Leach  10:09 Yeah, yeah, I've got, of course. So a couple things there. There's quite a few things we've done over time. And we continue to research on this. There's two aspects to sensor longevity. One of them is how long the sensor can remain accurate. And so within our device, we have algorithms that are checking the performance of the sensor at all times. And so there are times when we detect that that sensor signal is not accurate and not meeting the CGM standard. And so we we actually shut it off and that's when you get on the display, you get the sensor failed signal. That's basically we detected that that sensor is not working properly, and it's not going to return to functioning based on the data that we're seeing from it. As you mentioned, most people are able to get 10 days out of the sensor particularly now that we've made some changes with the adhesive as well. But there are some people who don't and with those folks, we often spend some extra time with our tech support, and kind of walk through what their issues are. And there's quite a few things that can be done to help sensors last longer. I mentioned the adhesive, we recently updated our adhesive, we've added an overlay. that's optional, people can ask if you have access to the clear adhesive that goes over the top of the white one that comes with the product. And so we're looking at lots of different ways. Because what we found is everybody's a little different in terms of what their needs are and what works for them. And so we're trying to do is have as many options that we can to make the sensors stay on and heared. And it's really that's our philosophy around sensor longevity is if I really wanted to I could I could run a study and claim that G6 goes 15 days because I know the performance would meet that the problem is not all the centers would last that long. And so what we're really after is making sure all the sensors, as many as we can get out to the labeled timeframe, not just some of them. And I think that's one of the key differences that you'll see over time between different CGM companies is we're very focused on a high level liability, you're never going to get 100%. You know, sensors will come off and they'll get knocked off. It's a challenge. But it's one that we're very focused on trying to ensure that we can have the highest flow reliability possible.   Stacey Simms  12:12 Let me just follow up on that, because sensor sticking is one thing, right? I mean, I know that that's an issue in everybody's skin is different. And you have the overlays now, and the adhesive does seem to be sticking better to many people. Butwhat about people who have no trouble getting the adhesive to stick in the wire to stay in, but get recurrent sensor failure? Are there any best practices for people who seem to get that over and over again,   Jake Leach  12:36 there are and it's actually often comes down to, you know, sensor placement and you know, the sensors indicated for abdominal use. And so, we often instruct folks to try at different locations. We've also, if someone's really having repeated challenges and where they're getting those sensor failures, we do have specific capability with our tech support to work with that customer and look at their data and To help determine exactly what is going on, there's a number of things to we tend to see, that happens when people are more dehydrated. So you know, kind of making sure they're well hydrated and drinking water. But if someone's having consistent problems all the time, then we really want them to reach out to us and talk to our tech support. And we can get someone who is experienced, but you know that those types of issues to talk to them and look at their data and help work through it.   Stacey Simms  13:22 I don't mean to harp on it. But I've just, and I'm, I know, you may not be the right person to try to pin down on this, so forgive me, but I'm thinking like, Is it an insertion thing is it I mean, we've, anecdotally, the community has said, drink water, stick in the fattest place you possibly can maybe rock the sensor a little when you're inserting it so it doesn't go as deeply in like it's more shallow. I'm just curious with all the data that you will collect in these phone calls. If there's any, like I said, a best practice that would help or if it's just you know, you've got to talk to your local rep, maybe get an in person or zoom call lesson or talk to tech support, but you know, just a more concrete business advice, I think would be so helpful.   Jake Leach  14:01 Yeah, I think a lot of it does have to do with that insertion saying, like you said, you want to put it into a place where you've got good interstitial tissue. The other thing I've seen, too, is, um, you want to make sure that it's not at a place where you're going to compress the center a lot, you know, if it's under compression, you're not getting the same amount of perfusion there have glucose under the skin. And so that can also lead to issues. There is something recently that we've released in a product that has really solved a number of issues in that people were getting sensor failures during really high glucose excursions. We've sent some solved that problem with a new version of our transmitter that is now out in the market, almost everybody has that device. Now, it did make quite a dent in those we were detecting the algorithm was detecting that really high glucose as a potential issue. And over time, we've learned through looking at the data that that wasn't an actual issue until we were able to correct that in a recent version of the device. But yeah, it does come down to kind of working through sensor insertion and placement in Don't have data that validates, you know, some of those techniques that you mentioned that says it will work if you do these things. But we have heard from the community, and in our own times speaking with patients that it has been very helpful. And some of those concepts you just mentioned.   Stacey Simms  15:14 Jake, I'm sorry, can I ask you to clarify? It may have gone over my head. But when you were mentioning the newer transmitter that is out, can you just clarify what you meant by when it was reading very high blood glucose? And that was affecting the sensor? And then it sounded like you said, but that wasn't the case. Can you just clarify that?   Jake Leach  15:31 Yeah, sure. So what it was, was that during really high glucose excursions, the device was detecting a potential sensor failure where it wasn't the sensor failure. There's nothing wrong with the sensor. It was working. But you know, it's one of those things that once you once you get a product on the market, you learn more about it. And so we've made several iterations to the G6 even since it's been in the market for several years to improve it. And that is one of the cases that we saw patients running into, that we resolved with the newest version of the device is that it doesn't give The sensor error when when there was really high glucose excursion,   Jake Leach  16:03 and I'm just curious cuz it does sound like you've resolved it. What is really high glucose? Like over 400?   Jake Leach  16:10 Oh, well north of 4, 5, 6 hundred.   Stacey Simms Oh my goodness,   Jake Leach  16:14 yeah, we're really, really high glucose.   Stacey Simms  16:16 So if somebody has a teenager who's like bumped up to 250 and getting sensor failure, that's not the issue.   Jake Leach  16:21 That's not the issue. No, no, no, not in not in those,   Stacey Simms  16:24 because everybody has a different idea of really high glucose. So Thanks for clarifying.   Jake Leach  16:27 Yeah, that's a good thing to clarify. Because, like you mentioned,   Stacey Simms  16:32 you know, another question that my listeners had was about data. And we've talked a little bit here about some of the data that you collect. And I don't know if it's different internationally, but to speak about the data.   Jake Leach  16:43 Yeah, sure. Of course, first of all, data privacy is very important, both just fundamentally and philosophically as well as to be in compliance with all the global regulation we're seeing in this area of data privacy. There's a lot of advancements in the laws and regulate Around consent, and users granting access to their data, because in the end, it's the users data. We're just a steward of it. And so we take it very seriously. And so in our processes and our controls, that's how we proceed. So the data that comes into our systems from the CGM devices are used for things like share. So we provide the share system, the remote monitoring, that connectivity is super important. The data is also through that same system made available to the clarity application for use by the patients or customers or their physician. And then we also have that data in a safe lockdown repository that can be used by our tech support agents. If users are having track challenges, like we talked about tech support agents can actually log in and work with that user on their specific data. But   Stacey Simms  17:48 hey, it's Stacey jumping in here. I need to insert myself into the interview with the episode here because we hADAn audio issue right there and it was completely my fault. So apologies. Dexcom is going gonna give you a full statement on data and privacy, and I will link it up in the show notes. So Jake can kind of continue his thought that way and give you the full statement. One thing he said that I thought was very interesting though was if you are concerned about privacy and want to opt out, you can just use the receiver all by itself. They don't collect any data that way. But then you can't use clarity or share the information online with caregivers or your health team. But if you want to opt out, that is one way to do it and still use the Dexcom system. I did follow up the data question with one about transmitting data and why it's limited to certain devices. If you use a tandem pump like we do, for example, the transmitter can send data to your phone and to the to the mix to pump but then not also to the receiver.   Jake Leach  18:52 Yeah, the ad goes down into the specific engineering of the device deep down inside the wearable, for example to the transmitter producer. There's a battery in there. Every connection to a display device takes a Bluetooth communication channel. And so today, which is six, we support two channels, one for mobile phone and one for a medical device such as the insulin pump, or the Dexcom. receiver, it can support to have those connections to the med devices, because we need one available for a phone. We are looking in the future to allow multiple different types of devices you can imagine watches and other things. And so that technology is we're working the architecture of that. But the key there is that circuitry has to be low enough power that it doesn't use up the battery. We specifically designed G6 to be reliable for that 90 day period for the mere life. And so we couldn't put that system you can't support more than those two connection.   Stacey Simms  19:45 Yeah, practically speaking for us. It's plenty. I was just curious about the thinking behind it. And is that going to be the same thing with the Omnipod five? horizon? I'm laughing because I have to figure out how to say that Omnipod five. will it be the same thing Work goes phone and PDM or something, or is that a different setup altogether?   Jake Leach  20:04 It's a little different. But it's it with the G6 integration, G6 will support the Omnipod five as well as a mobile app like a G6 app. So it does support that. And as we look into the future towards things like g seven and future versions of G7, we are looking at architectures that could support even more display devices, more than just two.   Stacey Simms  20:24 And I'll hope to talk to Insulet in the future to get the specifics. But as I'm asking you this question, that sounds a little ridiculous, because where would it show up on the pod? I guess it would show up on a PDF if you use that instead of a phone.   Jake Leach  20:34 Yeah, I think one way to look at it for all of these automated insulin delivery systems is you want good communication between the algorithm that is doing all of the calculations for how much influence to deliver, you want a good connection between that and the glucose signal and the pump that's doing the delivery. That's part of the system engineering of the of the product and part of G6 was designed specifically for interoperability with so that it can support use cases like that   Stacey Simms  20:59 you mentioned To watch, I did talk to Kevin about this. So I'm sorry to bring it up again. But my listeners are really waiting for that direct to watch component. Can you speak to that from your perspective?   Jake Leach  21:11 Yeah, sure. So, you know, it's a it's a feature that we've been working on in development for for quite a while. And as we've worked through it, well, it turns out, you know, on our side, as well as on the leaves, Apple Watches is one of the one of the examples other than a significant amount of engineering. I think that we all underestimated when we first started talking about that product in the way that it interacts with the G7, as well as the phone app. And so we've been working with Apple closely know, over the last couple of years, actually, when when they announced this feature, it was really kind of a prototype feature. We started working with them closely on it, making quite a few updates on both sides to support that type of a feature. And so while we don't have any dates, where we're going to launch it, it's important feature that we know, adds flexibility to users lives and so we will continue to work on it. But at this point in time, we don't have a specific comment.   Stacey Simms  21:57 Yeah, I'm curious um, before I let you go here, DiabetesMine, which is a really great news source, if as you listen, you're not familiar, I always read them. I think they're fantastic. They recently, earlier this year, put out an article, headline “39 potential new continuous glucose monitors for diabetes,” as some of these are never going to happen. A lot of these are, you know, non invasive wearables that, you know, look at a headline, and we may never see again, but some of these are going to happen. Jake, I know you all are watching the competition. You know, I know that, you know, Dexcom has enjoyed a long time here of not having a lot of competition, especially the United States. I'll give you the floor. Are you guys ready to take on these companies?   Jake Leach  22:39 Absolutely. I think the just notion that there's that many different companies and working in this space is kind of validating the concept that continuous glucose monitoring is the standard of care for diabetes management and so perfectly comfortable with Mark people working in this space and we continue to drive forward all of our efforts on advancing the technologies, whether it The performance of the sensor the longevity of the sensor, particularly the ease of use, and the integration of our CGM with other devices. And you know from what we've seen, it's a very large opportunity. There's a lot of people who could benefit from CGM, so we're comfortable not being the only player. And we actually going to welcome expansion of CGM space across the globe with other companies as well as tech from   Jake Leach  23:23 Well, thank you so much for jumping on. I feel like I got a double feature of Dexcom this week. So thank you for the info. It's always great to catch up.   Jake Leach  23:29 I appreciate it. Stacey. Thanks for having me.   Jake Leach  23:37 You're listening to diabetes connections   Jake Leach  23:39 with Stacey Sims.   Stacey Simms  23:43 More information in the show notes as always, the episode homepage and there is a transcript there there are important links. Same thing if you're listening in a podcast app, you should be able to get to the show notes. But you know some apps are weird and they don't post links and Apple podcasts which is the most common one. Used as kind of bad for that sort of thing. So I always put it on the episode homepage, which you can find at Diabetes connections.com. And a little bit on that audio error if you're interested. I mean, here's some inside baseball. But here's basically what happened. Whenever I do a remote interview, and probably 90% of the interviews on this podcast are remote, right? We're not together, I do them generally through Skype. And my computer is set up so that it automatically records when a Skype call is placed. I have a backup recorder. For those of you who are technical and want to know it's an h5 zoom, and it's fabulous. But it's an external recorder that's plugged into the computer and has an SD card inside of it. So this call like a couple I've done recently, our zoom calls, my computer is not set up to automatically record and you know, everybody knows zoom by now if you're not the host, you don't have the power to record well 99% of the time, I asked the host to please record it on their end and then send it to me as a backup and I just roll the h5 zoom over here. forgot to ask them To hit record, there's always a PR person on these calls, you know, Jake doesn't have to worry about it, they'll take care of it. But I forgot to ask her to do that. So I'm rolling on my end, but they weren't rolling on there. And then and this has never happened before, the SD card was full. And it's a huge SD card. I don't know what the data is. I'm not going to pop it out. Now, look, but you know, I cleared out periodically, but probably only once every six months. And oh, my gosh, I completely forgot to do it. So it just clicked off and stopped recording. I share this with you. Because I mean, we're more than 300 episodes in right. We're close. You know me, I know some of you, but I thought you might appreciate it behind the scenes look at some of the nonsense that goes on here. I was able to stop the interview, ask them to start rolling and then restart. But we did lose that part, which I hate about the data. I have talked to Dexcom in the past about data. I will link up the specific interview where I talked to them about that. And I will link up the statement that they gave me after the fact I asked them to email me some information about that. But you know, hey, we're not perfect around here and we don't pretend to be the next Episode shouldn't be an interview with tandem. if things work out. We're still in the process of moving some things around with ADA and breaking news, we always like to do the best we can. So tandem should be up next, please join the Facebook group Diabetes Connections, the group to stay up to date. And that's the best way to get your questions into these interviews. When I have something like this, I always ask and you guys are amazing at getting me great questions and letting me know what you want to talk about. So I appreciate that very much. Thank you as always to my editor john Buchanan's from audio editing solutions. And thank you very much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself, even if your SD card is full. Benny 26:45 Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged   Transcribed by https://otter.ai

One of Dexcom's mission statements is 'empowering people to take control of their diabetes'. George chats with Dexcom's Chief Technology Officer, Jake Leach about 'diabetes technology' and the accomplishments and technological advancements Dexcom has made. Their accurate and reliable continuous glucose monitors, including shareable glucose data on smart phones, have made them leaders and pioneers in the diabetes medical device world. Find out what’s coming from Dexcom in 2020.

Host Dave Franchino talks with Jake Leach, Chief Technology Officer at Dexcom, a pioneer and leader in continuous glucose monitoring systems for people managing diabetes. Jake discusses the challenges of the medtech startup world and what it takes to keep improving your product, year after year, for more than a decade.

James is joined by Jake Leach, Chief Technology Officer at Dexcom. Jake oversees the development of next generation products and his teams are responsible for delivering best in class glucose monitoring technology paired with an exceptional user experience. Jake joined Dexcom in March 2004 to lead development of sensor electronics which were part of the first generation Dexcom system. Jake has served in various roles within Dexcom including Senior Vice President of R&D, Senior Director of R&D, and Manager of Engineering. From 1996 to 2004, Jake held positions in research and development at MiniMed and subsequently Medtronic Diabetes, focusing on the development of glucose sensing systems. Jake holds a Bachelor of Science degree in Electrical Engineering with a minor in Biomedical Engineering from the University of California, Los Angeles. James and Jake talk about how Jake's background in engineering and his inquisitive mind set him up for a career in medical devices, how MiniMed and Dexcom scaled so fast and why the diabetes-tech space is so exiting right now. www.dexcom.com For more information and content, check out our website www.hs.ventures. You can follow us on Twitter @HSVenture, on Instagram @hs.ventures, on Linkedin at HS. and you can email us at info@hs.live You can get our host, Dr. James Somauroo, at www.jamessomauroo.com and you can follow him on Twitter @jamessomauroo, on Instagram @j_soms and on Linkedin at james-somauroo

Jake Leach is Dexcom's Chief Technology Officer and he's on the show to receiver your feedback, talk G6 enhancements and spill the beans about how Apple Watch will soon be helping you with your type 1 diabetes. Show notes for people who are Bold with Insulin Our Facebook pages have been merged Facebook.com/BoldWithInsulin > Find out more about the Dexcom CGM > Get an Omnipod Demo today  > Dancing4Diabetes.com > Save 20% on Realgood Foods, use JUICEBOX at checkout A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio Radio Public and all Android devices The show is now available as an Alexa skill. My type 1 diabetes parenting blog Arden's Day Listen to the Juicebox Podcast online Read my award winning memoir: Life Is Short, Laundry Is Eternal: Confessions of a Stay-At-Home Dad The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here. Thank you! Follow Scott on Social Media Twitter & Instagram @ArdensDay @JuiceboxPodcast Facebook @BoldWithInsulin 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.

Hey there Box Office Bros Listeners! Our 12th episode consists of the permanent replacement of Chance Oliver, and the harsh implications of it. All jokes aside, Chance is out of town so we have a new co-host for the week, Jake Leach! In this podcast we go on long winded rants about our favorite directors, and what we love and hate in the industry. It's a great time. Find a warm and cozy blanket, put in your choice of headphones and enjoy the podcast because it's a long one. --- Support this podcast: https://anchor.fm/boxofficebros/support

Dexcom Chief Technology Officer, Jake Leach, shares news of recent technological breakthroughs designed to improve life for people with diabetes. Learn how you can get your blood glucose levels in real time by using a new app to "ask Siri" for the information. Could this groundbreaking technology eliminate finger pricks forever?

Dexcom released an iOS update on February 27th and we take a deep dive into what's changed and ask about ongoing issues. Stacey talks with Dexcom Chief Technology Officer Jake Leach about the new Hey Siri feature as well as the new ability to add up to ten followers, get a 24 hour in advance sensor warning and direct to Clarity from the G6 app.  She also asks about Dexcom's recently announced layoffs, changes to the Follow app, direct to watch capability and G6 sensor issues. (Whew!) Join the Diabetes Connections Facebook Group!  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 

Dexcom is the leader in continuous glucose monitoring for people with diabetes. Released in June 2018, the Dexcom G6 continuous glucose monitoring system uses a small sensor placed on a patient’s lower abdomen that wirelessly sends their glucose levels to a smart phone, smartwatch or receiver, allowing them to closely and discreetly monitor their numbers without being required to prick their fingers for diabetes management. The system also has built-in alerts and alarms that proactively notify patients and their family and friends before their blood glucose reaches potentially dangerous levels. It really is a revolutionary, life-changing device. Jake Leach is Chief Technology Officer at Dexcom and joins me on this daily tech podcast to share how they are using sensors and wearables to transform the lives diabetics. He is responsible for the leadership of scientific research, engineering, product development, and project management. Jake oversees the development of next-generation products and leads a large organization of amazing people. His teams are responsible for delivering best in class glucose monitoring technology paired with an exceptional user experience.   

Dexcom's SVP of R&D returns to talk about Basal IQ (T-Slim), TypeZero and what's on the horizon for people living with type 1 diabetes.  Show notes for people who are Bold with Insulin > Find out more about the Dexcom CGM > Omnipod Demo information  > Dancing4Diabetes.com A full list of our sponsors  Check out the NEW Omnipod DASH PDM! The show is now available as an Alexa skill. Are you an Apple user? Subscribe to the podcast today! The podcast is available on Spotify , Google Play and 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 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! 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.

Jake Leach is Dexcom's Senior Vice President of Research and Development and he came on the podcast to tell us about what's coming from your favorite continuous glucose monitoring company. Type 1 diabetes management is about to get a whole lot better! Topics include: G5 Mobile improvements, NEW auto-applicator, New receiver, adhesive upgrade research, app customization, G5 battery shutdown, FDA approval for insulin dosing and (no over-exaggeration) MUCH, MUCH more! OmniPod: This episode of the Juicebox Podcast is sponsored by Insulet, makers of the world's only tubeless insulin pump. Try a free demo pump today {CLICK} Show Notes Visit Dexcom.com 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.