Diabetes Connections | Type 1 Diabetes

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.

The Overlooked Challenges of Women with type 1 diabetes, with Courtney Pickett 04/29/2025

G7 15-Day Approval: Dexcom’s Jake Leach Answers Your Questions 04/22/2025

In the News.. GLP-1 for T1D trials, Ozempic pill, Dexcom 15-day sensor, type 5 diabetes, and more! 04/18/2025

In the News.. GLP-1 for T1D trials, Ozempic pill, Dexcom 15-day sensor, type 5 diabetes, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Eli Lilly will start a lcinical trial for tirzepatide for people with type 1 diabetes, more details on Dexcom's 15 day G7 sensor, Ozepmic pill form tested, type 5 diabetes identified and more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Our top story this week.. Eli Lilly takes the first steps toward getting tirzepatide approved for people with type 1 diabetes. Tirzepatide is sold under the brand names Mounjaro for type 2 and Zepbound for obesity. The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or are overweight. Participation in the study will last about 49 weeks. Official Title A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight This is a big deal because, even though many people with type 1 are able to get a prescription for tirzepatide, it’s not approved for T1D and so insurers won’t usually cover it. XX The use of drugs like Ozempic, Wegovy and Zepbound in people with type 1 diabetes has risen sharply over the past decade, a new study finds, even though there’s little information on the drugs’ safety and effectiveness for the condition. The family of medications called GLP-1 receptor agonists includes drugs like Wegovy, Zepbound, Ozempic, Mounjaro and Victoza. But the clinical trials of these medications specifically excluded people with type 1 diabetes, who are dependent on the hormone insulin to survive because they can’t make enough of their own. Drugmakers feared that using the GLP-1 medications with insulin might raise the chance of dangerously low blood sugar events, or hypoglycemia, and were unwilling to take the risk of studying them in people with type 1. For the study, which was published last month in the journal Diabetes, Obesity, and Metabolism, researchers at Johns Hopkins University reviewed the medical records of more than 200,000 people with type 1 diabetes from 2008 to 2023. They grouped the data in three-year periods, starting with October 2008 to September 2011 and ending with October 2020 to September 2023. GLP-1 medication use spiked, as well. Among adults with the highest category of obesity, about 4% used GLP-1 medications in 2008, and 33% did by 2023 – an 800% increase. But these are anecdotal reports and may not reflect instances in which people have side effects or complications like low blood sugar, which can be life-threatening. But Shin says what’s really needed is information from randomized, double-blinded studies, in which participants are followed forward in time and given either a drug or a placebo. https://www.cnn.com/2025/04/09/health/glp-1-type-1-diabetes-study/index.html XX Later this month the FDA will conduct a final meeting regarding a new, investigational compound (sotagliflozin) soda-GLIFF-a-zin that has been shown to Improve QoL and Reduce Long-term Complications for people with type 1 diabetes (T1D). The patient advocacy group Taking Control of Your Diabetes (TCOYD.org) is working to inform the T1D community about sotagliflozin - and to encourage people to sign a Change.org petition directed towards FDA. Last fall, the FDA declined to approve sotagliflozin due to concerns about a potential increased risk of diabetic ketoacidosis (DKA), despite this being a condition that people with T1D on insulin face and manage daily. While TCOYD respects FDA’s caution, the group stands by T1D patients and their physicians who, as a team, balance risks and benefits every day. XX Dexcom receives FDA approval for it’s G7 with 15 day wear. We have an interview with Chief Operating Officer Jake Leach coming up on Tuesday – we talk about the planned roll out of this sensor, what else has changed, and the fine print in the press release – it says “A study was conducted to assess the sensor life where 73.9% of sensors lasted the full 15 days. When using the product per package labeling, approximately 26% of sensors may not last for the full 15 days. https://investors.dexcom.com/news/news-details/2025/Dexcom-G7-15-Day-Receives-FDA-Clearance-the-Longest-Lasting-Wearable-and-Most-Accurate-CGM-System/default.aspx?utm_source=www.diabetech.info&utm_medium=referral&utm_campaign=dexcom-g7-15-day-sensor-gets-fda-cleared-but-will-it-actually-last-that-long XX Glucotrack is joining something called FORGETDIABETES bionic pancreas initiative, - this is an European Union project that aims to develop a long-term automated insulin delivery system for type 1 diabetes patients. Glucotrack's Continuous Blood Glucose Monitor (CBGM) will be integrated into the system to provide real-time glucose readings. The initiative's goal is to create a bionic invisible pancreas that eliminates the need for therapeutic actions and reduces psychological burden. The architecture of BIP encompasses a ground-breaking, lifelong lasting implanted ip glucose nanosensor; a radically novel ip hormone delivery pump, with unique non-invasive hormone refill with a magnetic docking pill and non-invasive wireless battery recharge; an intelligent closed-loop hormone dosing algorithm, optimized for ip sensing and delivery, individualized, adaptive and equipped with advanced self-diagnostic algorithms. Pump refilling through a weekly oral recyclable drug pill will free T1D subjects from the burden of pain and awkward daily measurement and treatment actions. Wireless power transfer and data transmission to cloud-based data management system round-up to a revolutionary treatment device for this incurable chronic disease. key feature of BIP is to be fully-implantable and life-long lasting thanks to novel biocompatible and immune-optimized coatings guaranteeing long-term safety and stability https://www.stocktitan.net/news/GCTK/glucotrack-to-participate-in-forgetdiabetes-a-prominent-european-cjjldjb0dq7h.html XX A newly recognised form of diabetes, called Type 5, was announced this week at the World Congress of Diabetes 2025. A global task force will investigate this less-understood condition, which differs from Type 1 and Type 2 diabetes. Type 5 diabetes affects people who are underweight, lack a family history of diabetes and do not show the typical symptoms of Type 1 or Type 2 diabetes. The condition was first observed in the 1960s and referred to as J-type diabetes, after being detected in Jamaica. It was classified by the World Health Organisation in 1985, but removed in 1998 due to lack of physiological evidence. At the time, experts believed it to be a misdiagnosed case of Type 1 or 2 diabetes. New research has since confirmed that Type 5 is different. https://economictimes.indiatimes.com/news/new-updates/a-new-type-of-diabetes-has-been-found-by-scientists-and-it-doesnt-show-the-typical-symptoms-of-type-1-or-type-2/articleshow/120276658.cms?from=mdr XX Oral semaglutide cuts major heart risks in people with type 2 diabetes by 14%, offering a powerful pill-based option. A new clinical trial, co-led by endocrinologist and diabetes specialist John Buse, MD, PhD, and interventional cardiologist Matthew Cavender, MD, MPH, at the UNC School of Medicine, has demonstrated that the oral form of semaglutide significantly lowers the risk of cardiovascular events in individuals with type 2 diabetes, atherosclerotic cardiovascular disease, and/or chronic kidney disease. Results from the rather large, international trial were published in the New England Journal of Medicine and presented at the American College of Cardiology’s Annual Scientific Session & Expo in Chicago, Illinois. The effect of oral semaglutide on cardiovascular outcomes was consistent with other clinical trials involving injectable semaglutide, but more trials are needed to determine if one method may be more effective than the other at reducing major cardiovascular events. https://scitechdaily.com/new-pill-form-of-semaglutide-shows-major-benefits-for-people-with-diabetes/ XX April 14 (UPI) -- The U.S. Food and Drug Administration on Monday warned consumers and pharmacies that fake versions of Ozempic, a drug to treat Type 2 diabetes, have been found in the United States. Novo Nordisk, the Danish-headquartered manufacturer, informed the FDA on April 3 that counterfeit 1-milligram injections of semaglutide were being distributed outside its authorized supply chain. The FDA and Novo Nordisk are testing the fake products to identify whether they're safe. Patients are asked to obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for any signs of counterfeiting. People in possession of the fake product are urged to call Novo Nordisk customer care at 800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EDT and report it to the FDA's criminal activity division's website. Side effects can be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program (800-FDA-1088 or www.fda.gov/medwatch) as well as to Novo Nordisk, at 800-727-6500. https://www.upi.com/Health_News/2025/04/14/FDA-fake-Ozempic-drugs-Novo-Nordisk/6841744666854/ XX Can a digital lifestyle modification program reduce diabetes risk? A new study shows that the lifestyle intervention significantly reduced 10-year diabetes risk among prediabetics by nearly 46% and increased the diabetes remission rate, highlighting the importance of lifestyle changes. However, the study was not a randomized trial, and participation in the lifestyle intervention was voluntary, which may introduce selection bias. The study evaluated 133,764 adults, categorizing them as diabetic (7.5%), prediabetic (36.2%), and healthy (56.3%), based on fasting glucose and HbA1c levels. XX Chrissy Teigan is speaking out about her son’s type 1 diagnosis – teaming up with Sanofi to encourage people to screen early for Type 1 diabetes. Teigen got a crash course in the risks of undiagnosed Type 1 diabetes when her 6-year-old son, Miles, was hospitalized with complications of the autoimmune disease last year. The family knew nothing about Type 1 diabetes when Miles was diagnosed during an unexpected medical emergency, Teigen said in a Tuesday announcement. “We were confused and scared when Miles was first diagnosed,” she said in a statement. “There is no doubt in my mind that knowing in advance would have made a positive impact for Miles, me, and our entire family. I want everyone to hear me when I say: stay proactive and talk to your doctor about getting yourself or your loved ones screened for type 1 diabetes today!” Teigen shared her family’s story in a two-minute video on ScreenForType1.com, a Sanofi website that discusses how to get screened for the condition. Miles’ diagnosis made Teigen feel like she “went from a mom to a doctor overnight,” she said. That experience is why Teigen said she is “begging you: Do this one thing, and screen yourself and your family for Type 1 diabetes.” XX Dr. Richard Bernstein – best known for his advocacy around low carb diets for people with diabetes – died this week at the age of 90. Born in 1934 in Brooklyn, New York, he was diagnosed with type 1 at age 12. In the 1970s he adapted a blood glucose monitor for home use and helped pioneer home glucose monitoring. He published multiple books on Diabetes including the #1 selling Diabetes book on Amazon.Com “Dr. Bernstein’s Diabetes Solution: A Complete Guide to Achieving Normal Blood Sugars” and “Diabetes Type II: Living a Long, Healthy Life Through Blood Sugar Normalization”. He practiced and saw patients right up until his death. /episode/index/show/diabetesconnections/id/36205185

The iLet, Two Years In: Real-World Insights & What’s Next for Beta Bionics with Chief Medical Officer Steven Russell 04/15/2025

The DRI is "Aggressively Working" on a T1D Cure. What does that mean? 04/09/2025

GlucoSense is on a Mission to Simplify T1D Management 04/01/2025

In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more! 03/28/2025

In the News.. FDA warns Dexcom, Inreda dual-chambered pump, using insulin with GLP-1 meds studied, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Learning more about the FDA letter sent to Dexcom, news from ATTD including a bihormonal pump from a Dutch company, time in tight range update, more studies about using insulin and GLP-1 medications, eating chili to prevent gestational diabetes (really!) and more.. Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Our top story this week: Dexcom Dive Brief: A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom’s continuous glucose monitors. The FDA raised concerns with a design change to a component used in the resistance layer of Dexcom’s sensors. The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note Tuesday that the letter concerns a chemical compound that the sensor wire is dipped in. Dexcom began producing the compound internally to add redundancy to its supply chain. Dive Insight: Dexcom Chief Operating Officer Jake Leach said in an interview with MedTech Dive last week that the company does not expect the warning letter to affect future product approvals, including a 15-day version of its G7 CGM, and there’s no need yet to recall products. Dexcom has submitted the device to the FDA and anticipates a launch in the second half of the year. Marcus, after speaking to company leadership and a quality control expert, wrote that many of the issues outlined in the letter could be addressed quickly. He added that the warning letter could explain minor delays in approval to the 15-day sensor, but Dexcom is still within the 90-day window for a 510(k) submission. “While there’s always a risk this could impede future product approvals,” Marcus wrote, “we do not expect this to materially delay the 15 day G7 sensor approval.” The warning letter followed an FDA inspection last year of Dexcom’s facilities in San Diego and Mesa, Arizona. Marcus wrote that after the FDA requested additional information and a separate 510(k), Dexcom stopped in-sourcing the compound and reverted back to the external supplier. Dexcom’s devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors with the changed coating “cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions,” the letter said. The FDA raised other concerns in the warning letter, including procedures to monitor the glucose and acetaminophen concentrations used in testing of the G6 and G7 CGMs. The FDA also cited problems with Dexcom’s handling last year of a deficiency in its G6 sensors with dissolved oxygen content values, a key input for measuring blood glucose levels. https://www.medtechdive.com/news/dexcom-warning-letter-cgm-coating-change/743597/ XX Lots of studies and info out of the recent ATTD conference. One highlight that has been sort of under the radar: a Dutch company has been using a Bihormonal fully closed-loop system for the treatment of type 1 diabetes in the real world. This is a company called Inreda (in-RAY-duh). The Inreda AP® is an automatic system (closed loop) and independently regulates the blood glucose level by administering insulin and glucagon. The AP5 is certified in Europe and is being used in multiple studies and projects. The AP®6 is currently under development. https://www.inredadiabetic.nl/en/discover-the-ap/ XX Let’s talk about time in tight range. If you follow me and diabetes connections on social, you likely saw a video I made about this – it blew up last week. If not.. time in range has been a metric for a short while now.. in 2019 there was a consensus report advising a goal of 70% of time in the 70-180 mg/dL range for most people with type 1 diabetes (T1D) and type 2 diabetes (T2D), with modifications for certain subgroups. Recently we’ve been hearing more about 70-140 mg/dL — for longer periods as “time in tight range (TiTR).” At ATTD there was more talk about calling that range TING, or “time in normal glycemia. There’s a great writeup that I’ll link up from the great Miriam Tucker on Medscape about a debate that happened at ATTD. On March 22, 2025, two endocrinologists debated this question at the Advanced Technologies & Treatments for Diabetes (ATTD) 2025. Anders L. Carlson, MD, medical director of the International Diabetes Center (IDC), Minneapolis, took the positive side, while Jeremy Pettus, MD, assistant professor of medicine at the University of California San Diego, who lives with T1D himself, argued that it’s too soon. XX Sequel Med Tech announces its twist pump will be firs paired with Abbott’s FreeStyle Libre 3 Plus. The twist has FDA approval for ages 6 and up and is set to begin its commercial launch by the end of June. The pump—designed by inventor Dean Kamen’s Deka Research & Development—also incorporates the FDA-cleared Tidepool Loop software program, to record CGM blood sugar readings, make predictions based on trends and adjust its background insulin levels accordingly. https://www.fiercebiotech.com/medtech/sequel-med-tech-connects-twiist-insulin-pump-abbotts-cgm-ahead-market-debut XX Dexcom's longer-lasting CGM sensor looks promising, based on presented at the conference. The trial showed that the new 15-day G7 system is slightly more accurate than the current G7. The accuracy of CGM can be measured using MARD (mean absolute relative difference), which shows the average amount a CGM sensor varies from your actual glucose levels (a lower number is better). The 15-day G7 has a MARD value of 8.0%, about the same as the Abbott Freestyle Libre 3. The Dexcom G7 15 Day is awaiting FDA approval and is not yet available in the U.S. XX Little bit of news from Modular Medical.. they plan to submit their patch pump to the FDA late summer or fall of this year. The MODD1 product, a 90-day patch pump, features new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe. It has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery. Modular Medical picked up FDA clearance for MODD1 in September. The company also . Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump. By developing its patented insulin delivery technologies, the company hopes to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump. https://www.drugdeliverybusiness.com/modular-medical-announces-12m-private-placement/ XX More from attd – type 2 news? XX Another study that says people with type 1 who use a GLP-1 medication get better outcomes. In this study, those who use GLP-1 with insulin are 55% less likely to have a hyperglycemia-related ED visit, 26% less likely to have an amputation-related visit, and 29% less likely to have a diabetic ketoacidosis (DKA)-related ED visit in the following year compared to those on insulin alone. Although they are not approved for T1D, some patients may receive them off-label or for weight control. Pretty big study for an off label drug: compared 7,010 adult patients with T1D who were prescribed GLP-1s and insulin to 304,422 adult patients with T1D who were on insulin alone. It is important to note that the rates of new diabetic complications in one year for both groups were around 1%, indicating that these are uncommon outcomes regardless of medication use. https://www.epicresearch.org/articles/some-diabetic-complications-less-likely-among-type-1-diabetics-on-glp-1s XX Early research here but exposure to antibiotics during a key developmental window in infancy may stunt the growth of insulin-producing cells in the pancreas and boost risk of diabetes later in life The study, is published this month in the journal Science, it’s a study in mice. These researchers are working off the idea that when while identical twins share DNA that predisposes them to Type 1 diabetes, only one twin usually gets the disease. She explained that human babies are born with a small amount of pancreatic “beta cells,” the only cells in the body that produce insulin. But some time in a baby’s first year, a once-in-a-lifetime surge in beta cell growth occurs. “If, for whatever reason, we don’t undergo this event of expansion and proliferation, that can be a cause of diabetes,” Hill said. They found that when they gave broad-spectrum antibiotics to mice during a specific window (the human equivalent of about 7 to 12 months of life), the mice developed fewer insulin producing cells, higher blood sugar levels, lower insulin levels and generally worse metabolic function in adulthood. in other experiments, the scientists gave specific microbes to mice, and found that several they increased their production of beta cells and boosted insulin levels in the blood. When male mice that were genetically predisposed to Type 1 diabetes were colonized with the fungus in infancy, they developed diabetes less than 15% of the time. Males that didn’t receive the fungus got diabetes 90% of the time. Even more promising, when researchers gave the fungus to adult mice whose insulin-producing cells had been killed off, those cells regenerated. Hill stresses that she is not “anti-antibiotics.” But she does imagine a day when doctors could give microbe-based drugs or supplements alongside antibiotics to replace the metabolism-supporting bugs they inadvertently kill. . “Historically we have interpreted germs as something we want to avoid, but we probably have way more beneficial microbes than pathogens,” she said. “By harnessing their power, we can do a lot to benefit human health.” https://www.eurekalert.org/news-releases/1078112 XX Future watch for something called BeaGL - created by researchers at the University of California Davis and UC Davis Health who were inspired by their own personal experiences with managing T1D. BeaGL is designed to work with CGMs and has security-focused machine learning algorithms to make predictive alerts about anticipated glucose changes, which are sent to a device. In this case, a smartwatch. The end goal is for BeaGL to be completely automated to reduce the cognitive load on the patient, particularly for teens. It’s still in research phase but six student with T1D have been using it for almost a year. https://health.ucdavis.edu/news/headlines/with-ai-a-new-metabolic-watchdog-takes-diabetes-care-from-burden-to-balance/2025/02 XX Investigators are searching for a way forward after two long-term diabetes programs were terminated following the cancellation of their National Institutes of Health (NIH) funding, the result of federal allegations that study coordinator . The programs include the three-decades-old Diabetes Prevention Program (DPP) and its offshoot, the Diabetes Prevention Program Outcomes Study (DPPOS). “We are reeling,” said David Nathan, MD, a previous chair of both the DPP and the DPPOS and an original leader of the landmark Diabetes Control and Complications Trial. Nathan is also founder of the Massachusetts General Hospital Diabetes Center in Boston, one of the 30 DPPOS sites in 21 states. On March 7, the Trump administration cancelled $400 million in awards to Columbia University from various . While Columbia University agreed on March 21 to to respond to the Trump administration’s charges, in the hopes that the funding would be restored, DPPOS Principal Investigator Jose Luchsinger, MD, told Medscape Medical News that as of press time, the study was still cancelled. https://www.medscape.com/viewarticle/diabetes-prevention-program-cancellation-colossal-waste-2025a100076h XX XX Type 2 diabetes may quietly alter the brain in ways that mimic early Alzheimer’s. This was only an animal study – but researchers say the high comorbidity of type 2 diabetes (T2D) with psychiatric or neurodegenerative disorders points to a need for understanding what links these diseases. XX Eating chili once a month when you’re pregnant seems to lower the risk of developing gestational diabetes. This is a real study! While chili showed a link to lower gestational diabetes risk, dried beans and bean soup had no significant effect, even among women who ate them more frequently. Some studies suggest that diets high in beans and legumes, including the Mediterranean diet, reduce GDM risk. While studies link beans to lower diabetes risk, their specific impact on GDM remains unclear. This study analyzed data from 1,397 U.S. pregnant women who participated in the Infant Feeding Practices Study II, conducted between 2005 and 2007. Chili consumption varied significantly by race, education, household size, income, supplemental nutrition status, and region. Non-Hispanic Black mothers consumed the most (0.33 cups/week), while those with higher income and education levels consumed less. Regional differences also influenced chili intake. One possible mechanism for chili’s effect is capsaicin, a bioactive compound found in chili peppers, which has been linked to metabolic benefits in other studies. However, further research is needed to confirm this potential role in GDM prevention. Dried bean and bean soup consumption had no clear association with GDM. The study highlights limitations due to self-reported dietary data and the need for more detailed dietary measures. https://www.news-medical.net/news/20250317/Could-a-little-spice-in-your-diet-prevent-gestational-diabetes.aspx XX /episode/index/show/diabetesconnections/id/35905230

504 Plans Under Fire: What Parents Need to Know Right Now 03/25/2025

Tandem Releases Control IQ+ Software - What's new? (Bonus Episode) 03/19/2025

Teeing It Up with T1D: Meet PGA Pro Morgan Reimler 03/18/2025

In the News... Ozempic for T1D, aging and type 1, new help for diabetes and eating disorders, and more! 03/14/2025

RV Life with T1D: Chris & Amanda on Full-Time Family Travel 03/11/2025

T1D, Connection, and People Magazine: Elise & Zach share their story 03/04/2025

In the News... New research in T1D prevention, fast-acting biosimilar insulin approved, Lilly lowers Zepbound price, and more! 02/28/2025

In the News... New research in T1D prevention, fast-acting biosimilar insulin approved, Lilly lowers Zepbound price, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: New drug is looked at for T1D prevention, a new stem cell method is tested for beta cell transplanation without immunosuppresion drugs, the FDA okays the first fast-acting biosimilar insulin, Lilly lowers price of Zepbound, and more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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 New research in type 1 diabetes prevention launches. Nektar Therapeutics and TrialNet will evaluate a drug currently used for exzema for patients with new onset stage 3 type 1 diabetes The drug is RezPeg – that’s a shortened version of the name (rezpegaldesleukin) This will be a study of about 70 adults and children and will launch this year. The new study will use a mixed meal tolerance test (MMTT) to measure the efficacy of rezpegaldesleukin or placebo for preserving C-peptide area under the curve over a 12-month duration comprised of a 6-month treatment period and a 6-month follow-up. Secondary objectives include pharmacokinetics, pharmacodynamics, and additional disease assessments including HbA1c levels and patient insulin requirements. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. https://www.prnewswire.com/news-releases/nektar-announces-clinical-trial-agreement-to-evaluate-rezpegaldesleukin-in-patients-with-new-onset-type-1-diabetes-mellitus-302383052.html XX NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression. The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials. IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon. XX FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency has given a thumbs up to Sanofi’s Merilog (insulin-aspart-szjj) as the first biosimilar to Novo Nordisk’s NovoLog for patients with diabetes. Merilog will be provided by prefilled pen in a 3 mL dose or in a multiple-dose 10 mL vial. It is for adults and pediatric patients age 6 and older. NovoLog and Novo Nordisk’s other rapid-acting insulin follow-on Fiasp are among the drugs subject to government price negotiations under the Inflation Reduction Act. The new prices will be enacted at the start of next year. In July 2021, the FDA approved Biocon and Viatris’ Semglee (insulin glargine-yfgn) as the first biosimilar to Lantus. Five months later, the U.S. regulator endorsed Eli Lilly’s version of the drug, called Rezvoglar (insulin glargine-aglr). https://www.fiercepharma.com/pharma/fda-signs-sanofis-biosimilar-first-novo-nordisks-rapid-acting-novolog XX Eli Lilly said Tuesday that it will offer more doses of its obesity drug Zepbound in vials and lower the prices of the doses it already sells, as the pharma giant seeks to draw patients away from cheap, compounded copies of weight loss medications. The company launched 7.5 mg and 10 mg vials of tirzepatide, sold under the brand name Zepbound, which typically cost $599 and $699, respectively. However, they are now available for $499 per month for patients paying without insurance. This applies to the first fill and all refills that are delivered every 45 days. Additionally, the company lowered the prices of the 2.5 mg and 5 mg vials to $349 and $499 per month, respectively. The company, which has seen a significant boost in profits from Zepbound and Mounjaro – essentially the same drug with different FDA-approved uses – announced that the new vials and pricing are exclusively available through the company’s self-pay pharmacy, LillyDirect Self Pay Pharmacy Solutions. XX Medicare spending on 10 diabetes drugs, including popular GLP-1s, more than quadrupled over a five-year period and could reach $102 billion next year, an analysis by Health and Human Services' inspector general found. The findings also come as the Trump administration weighs the fate of a Biden administration proposal that would require Medicare and Medicaid to cover GLP-1s for weight loss. The biggest spikes in usage were for Rybelsus, Novo Nordisk's once-daily GLP-1 tablet, and for the company's weekly injectable Ozempic, whose spending about doubled every year under review. https://www.axios.com/2025/02/25/medicare-spending-surge-diabetes-drugs XX Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up Control IQ for use in adults with Type 2 diabetes. The expanded label was based on data from a pivotal, randomized trial of more than 300 people with Type 2 diabetes, comparing its use to manual multiple daily injections. Tandem said it plans to present the study’s results at the annual Advanced Technologies & Treatments for Diabetes meeting scheduled for next month in Amsterdam. https://www.fiercebiotech.com/medtech/tandem-diabetes-care-insulin-dosing-algorithm-nets-fda-clearance-type-2-diabetes XX Drugs approved for diabetes and obesity might be useful for the treatment of cognitive and mental health disorders, according to a new paper published in Nature Mental Health. The study reviewed and integrated data from both preclinical and clinical studies to gather evidence on the possible effects of these drugs GLP1s and semaglutide in conditions such as dementia, substance use disorders, psychotic disorders, mood and anxiety disorders, and eating disorders. The study found promising but still preliminary evidence that GLP-1RAs could be beneficial over a range of cognitive and mental health disorders. These drugs have shown potential in improving cognition, reducing addictive behavior, and alleviating depression and anxiety. More data from robustly designed studies (i.e., randomized controlled trials) are needed to better understand GLP-1RAs' prospective efficacy and safety profile, especially with long-term use. XX The FDA issued draft guidance that includes recommendations to support the development and marketing of safe and effective AI-enabled The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers with an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure the safety and effectiveness of AI-enabled devices. FDA is requesting public comment on this draft guidance by April 7. The agency also for the use of AI to support regulatory decision-making for drug and biological products. https://www.mddionline.com/artificial-intelligence/fda-issues-draft-guidance-for-ai-enabled-devices-seeks-public-feedback XX Congrats to Mila Clarke who some of you may know better as Hangry Woman on social. She has developed a great app called Glucose Guide and the Nutrition Assistant portion of that app went live this week. Glucose Guide is a web and mobile app that offers diabetes meal tracking, coaching, resources, recipes and community to those looking for help managing diabetes. MEAL AND BLOOD SUGAR TRACKING FEATURES. 📢 🗓️Mark your calendars for our launch on February 26! 📰 Make sure you're signed up for my newsletter, so you know when these features go live: https://hangrywoman.myflodesk.com/subscribe 💥Plus, if you are one of the first 100 people to sign up on launch day, you'll get a VERY special deal. 📲I'll be sharing some sneak peeks of our new tools. I'm over the moon. FINALLY a tracker that keeps blood sugar tracking aligned with meal tracking, exercise, sleep, mood, and more. Oh, and did I mention it'll analyze your fridge? You can scan photos of your plate and it will give you recommendations on what to adjust for better blood sugar balance? https://nutrition.glucoseguide.app/ XX And finally, gold medal Olympian Jordan Chiles is speaking out about diabetes. The gymnast’s aunt lives with type 1. Chiles is teaming up with Sanofi to talk about auto antibody screening https://beyondtype1.org/gymnast-jordan-chiles-personal-reason-for-type-1-diabetes-advocacy/ /episode/index/show/diabetesconnections/id/35473010

“Above the Bias” - How Diabetes Stigma Hurts Health & What We Can Do 02/25/2025

Bonus Episode: AMA Panel with Kerri Sparling & Kenny Rodenheiser – Honest, Smart & Funny Conversations About Life with T1D 02/21/2025

Diabetes Camp in 2025: What Parents Need to Know 02/18/2025

Diabetes Tech Hype vs. Reality: A Candid Talk with David Kliff 02/11/2025

In the News... FDA warns about smartphone medical alerts, new tubeless pumps in the works, T1D at the Super Bowl... and more! 02/07/2025

In the News... FDA warns about smartphone medical alerts, new tubeless pumps in the works, T1D at the Super Bowl... and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: the FDA has a warning about smart phones and medical alerts, a few companies turn their attention to patch pumps, a new study looks at costs/benefits of CGM vs Fingerstick during pregnancy, T1D in the Super Bowl.. and more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Big warning from the FDA about medical alerts from smart phones. They’re warning that they’ve received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low blood sugar and even death. But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical updates. In other cases, connecting the phone to a new audio source, such as a car stereo, could change the volume of the alerts users are accustomed to hearing. They have some recommendations to help, mostly just confirming alarms are working before you need them.. and I’ll link up the full story in the show notes. Reading between the lines here, it seems like the problem here may be the thousands of unregulated apps that make health claims – not just for people with diabetes. So it’s a good idea to check the apps you’re using and the companies that make them. XX What costs less during pregnancy? CGM or finger sticks? In the real word, a new study says CGM costs less… Okay, first keep in mind that the cost savings here wasn’t about the glucose monitoring supplies, it was about a lower rate of neonatal ICU admissions. In a base-case analysis in which researchers assumed all women would use seven finger sticks per day as dictated by the American Diabetes Association’s guidelines for diabetes management in pregnancy, CGM had a higher per-person cost than SMBG. However, in a real-world analysis in which women with a CGM used three finger sticks per day and those performing SMBG used five finger sticks daily, CGM was more cost-effective. In the real-world analysis, CGM users had a per-person cost of $2,747 for the CGM, $988 for finger sticks and $9,973 for neonatal ICU admissions. For SMBG, finger sticks cost $1,647 and neonatal ICU admission costs were $12,876. The reduction in neonatal ICU admission rates with CGM use led to a mean cost savings of $2,903 in the real-world analysis. “These findings justify paying for CGM devices in type 1 diabetes pregnancies, even in the U.S., which has an expensive health care system,” Polsky said future research should focus on the cost-effectiveness of automated insulin delivery systems in pregnancy. “Automated insulin delivery use has been shown to improve glycemic outcomes in type 1 diabetes pregnancies, but it is still unclear if it improves maternal or neonatal health outcomes and if it would be cost-beneficial,” Polsky said. https://www.healio.com/news/endocrinology/20250205/cgm-may-lead-to-lower-health-care-costs-for-pregnant-women-with-type-1-diabetes XX Couple of interesting comments from Medtronic at the recent JP Morgan Chase conference. The CEO says he company is “mainly a type 1 business, moving into type 2,” He says stated that their patch pumps program remains dynamic.. Medtronic expects its 800-series pump to come in at around half the size of the latest-generation 780G. The post says the company plans for a pivotal study in 2025. Potential features could include extended reservoirs and extended-wear sets, plus a brand-new Android/iOS app. XX Beta Bionics also says they’re working on a tubeless patch that they plan to launch in 2027. The company the device has two parts. One reusable component holds the electronics that operate the device and motor. A second disposable part includes an adhesive patch, insulin reservoir, insertion device, and the cannula used to deliver insulin. Beta Bionics said the pump is planned for use in people with type 1 diabetes and later will expand its use for people with type 2. The company also reported it is continuing work on an AID system that would, in addition to using insulin to lower blood sugar, also contain glucagon to raise blood sugar. is being conducted into systems, but none are available yet for people with diabetes. https://diatribe.org/diabetes-technology/tech-watch-diabetes-tech-news XX New approval for the treatment of diabetic macular edema. Susvimo is the “first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections,” the release said. This is the second indication for Susvimo, which is also approved for the treatment of wet age-related macular degeneration. https://www.healio.com/news/ophthalmology/20250204/fda-approves-susvimo-for-diabetic-macular-edema XX How about this one… drinking ketones improves heart health, a new small-scale study from the University of Portsmouth has found. This is the first time people with type 2 diabetes (T2D) have been given a drink with ketone esters - a supplement that is meant to plunge your system into ketosis - to monitor the effect on the heart. Ketosis is the metabolic state where your body is forced to burn fats instead of carbohydrates. but more research is needed because we only assessed participants on the day, which means we have no idea what the chronic impact of drinking ketones would be." The study was carried out after research showed The drug SGLT2i was used to lower glucose in patients with diabetes and longitudinal studies were showing that it was inadvertently protecting the heart. The hypothesis was that the drug induces ketosis and the heart was using ketones, which improved heart health, but the evidence for this was limited so our research set out to prove the connection." https://www.news-medical.net/news/20250205/Drinking-ketones-improves-heart-health-for-people-with-type-2-diabetes.aspx XX Another pump wants into the EU. Modular Medical looks to obtain a CE mark in the first quarter of 2026. The patch pump, MODD1, got FDA clearance last fall. The company says it will be available early this year.. but I haven’t heard much about it since the approval. https://www.drugdeliverybusiness.com/modular-medical-step-forward-ce-mark/ XX New CGM system with a reusable applicator and rechargeable wearable transmitter moves forward. Trinity Biotech announced new pre-pivotal clinical data. This company is based in Ireland and is looking for iCGM approval down the road.. hoping to file with the FDA in 2026. XX Body-weight cycling (also known as yo-yo dieting) has been shown to significantly increase the risk of kidney disease in people with type 1 diabetes, regardless of body mass index (BMI) and other traditional risk factors. This is a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. Participants with greater weight fluctuations experienced a 40% decline in kidney health from baseline values XX Eli Lilly’s profit doubled in the fourth quarter, propelled by its hot-selling diabetes and obesity treatments, and the drugmaker came out with a mostly better-than-expected 2025 forecast. Overall, Lilly’s quarterly profit swelled to $4.41 billion. https://apnews.com/article/eli-lilly-fourth-quarter-mounjaro-zepbound-ca026922525a9e3abb1b75d329628bef XX Abbott starts a new campaign all about bias and misconceptions when it comes to diabetes. I’m excited that they seem to have worked here with the Behavioral Diabetes Institute. Nearly 70% believe there is stigma associated with their condition.1 Diabetes as a Punchline: 85% of people living with diabetes say they have seen inaccuracies about diabetes in the media, including on TV shows, movies, and social media, and 40% of people felt that diabetes is often used as the punchline of a joke.1 Abbott's new Above the Bias initiative aims to help others see the world from the perspective of someone living with diabetes. The initiative builds upon efforts by several diabetes organizations, patient advocacy groups, and experts that continue to work to reduce .3 People can learn more about Above the Bias and watch the film at . https://www.prnewswire.com/news-releases/abbotts-above-the-bias-film-reveals-misconceptions-can-impact-diabetes-care-302367723.html -- When you watch the Super Bowl this weekend, watch for Noah Grey. .he’s the Kansas City Chiefs tight end who backs up Travis Kelce and he’s lived with type 1 since age 18. Grey spoke to media this week about how he loves to interact with kids who have T1D and their shared love of fruit gummies to treat lows. (sound here) Grey has been an ambassador for Tandem Diabetes and has talked about how he unhooks the pump but keeps his Dexcom on for games. -- I want to take a moment to personally send my love and sympathy to the Gaskins family. These are the folks behind the amazing Macey’s Believer’s charity. Janice Gaskins passed away this week after a long fight with breast cancer. I’ve been reading all of the posts on her Facebook page – this is a woman who touched and changed a lot of lives.. so much for the better. May her memory be a blessing. Her life certainly was. /episode/index/show/diabetesconnections/id/35183500

The Power of Giving: Can Helping Others Improve YOUR Diabetes Health? 02/04/2025

Type 1 Diabetes and Down Syndrome: Navigating A Double Diagnosis 01/28/2025

In the News.. Dexcom 15-day sensor update, TrialNet milestone, Beta Bionic IPO, and more! 01/24/2025

In the News.. Dexcom 15-day sensor update, TrialNet milestone, Beta Bionic IPO, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Dexcom updates investors on its 15-day sensor, TrialNet marks a big anniversary, Beta Bionics goes public, NFL fans support Mark Andrews and much more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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 Couple of quick updates from the JP Morgan Healthcare Conference. Dexcom’s CEO Kevin Sayer expects to launch a 15-day sensor in the second half of the year. That’s in front of the FDA right now. Competitor Abbott currently has 15-day sensors with its Freestyle Libre 2 Plus and Freestyle Libre 3 Plus devices, which the FDA cleared in 2023. Sayer also talked about expanded insurance coverage for the G7, to include more people with type 2. They haven’t pursued that with Stelo, the OTC version of their sensors. The company has begun work on a next-generation CGM. Sayer said the sensor will be smaller, less expensive and include better electronics. Dexcom is also studying new sensor probes, one of which can support multiple analytes, such as measuring lactate or ketones in addition to insulin. https://www.medtechdive.com/news/dexcom-ceo-stelo-otc-strategy-jp-morgan/737424/ XX TrialNet reaches a big milestone – more than a quarter million people have learned their risk of developing T1D through screening. TrialNet screening is available to family members of those diagnosed with T1D. Having a family history of the disease places individuals at a 15 times greater risk than those with no family members with T1D. Over the course of VUMC’s 18 years participating in the program, the community of T1D patients has become increasingly more engaged with research efforts. More than ever, there is an eagerness to give back to others by participating in clinical trials that could help revolutionize care for those diagnosed with or at risk of developing T1D. In such trials, TrialNet typically takes drugs already shown to be effective in treating other autoimmune diseases and seeks to determine their efficacy in treating, delaying or preventing T1D. Spencer Mannahan, a 10-year-old patient at Monroe Carell Jr. Children’s Hospital at Vanderbilt, is participating in a TrialNet study that is looking to determine whether a treatment regimen using both rituximab and abatacept can preserve insulin production in patients newly diagnosed with T1D. Russell, one of the PIs for the study (Protocol TN-25), also treated Spencer’s father, Zach, when he was diagnosed with T1D as a child. She enrolled in a different TrialNet study (Protocol TN-31) examining the effect of abrocitinib and ritlecitinib on insulin production in newly diagnosed individuals. While the possibility exists that her insulin production could be preserved, O’Neal joined the study because it presented an opportunity to make a positive impact on future patients. These clinical trials support TrialNet’s goal of a future without T1D. Research is underway on new methods of blocking the advance of T1D in patients with diabetes-related antibodies. One study will investigate whether T cells that have been activated against insulin can be specifically targeted, rather than issuing a treatment that targets all the body’s T cells (thus rendering the patient immunocompromised). TrialNet, the largest clinical trial network assembled to change the course of Type 1 diabetes, is funded by the National Institutes of Health through grant number NCT00097292. For more information about screening for Type 1 diabetes risk if it runs in your family, contact [email protected], visit www.trialnet.org, or contact the Vanderbilt Type 1 Diabetes TrialNet Program at 615-936-8638. https://news.vumc.org/2025/01/22/milestone-in-vumc-affiliated-diabetes-screening-and-research-program-underscores-impact-of-clinical-trials/ XX Another study links air pollution to type 2 diabetes. This is from Wayne State University, and established a robust association between exposure to benzene, a prevalent airborne volatile organic compound, and insulin resistance in humans across all ages. “In this study, we exposed mice to benzene to see how it affects their blood glucose levels and energy expenditure,” she explained. “Our research revealed that within seven days of exposure, they developed high blood glucose insulin levels.” https://today.wayne.edu/medicine/news/2025/01/23/study-links-air-pollution-exposure-to-type-2-diabetes-susceptibility-65321 XX Adults with overweight or obesity and type 2 diabetes who are given the sodium glucose cotransporter 2 (SGLT-2) inhibitor drug dapagliflozin alongside moderate calorie restriction achieve much higher rates of remission compared with calorie restriction alone. The researchers say this study provides a practical strategy to achieve remission for patients with early type 2 diabetes. As well as helping to lower blood sugar levels, SGLT-2 inhibitors can also lead to weight loss, but their effect alongside calorie restriction on diabetes remission has not yet been investigated in a randomised controlled trial. To address this, researchers carried out a trial involving 328 patients with type 2 diabetes of less than six years' duration at 16 centres in mainland China from 12 June 2020 to 31 January 2023. Participants were aged 20-70 years with a body mass index (BMI) greater than 25 and were not taking any anti-diabetic medication other than metformin. https://www.news-medical.net/news/20250123/Dapagliflozin-and-calorie-restriction-show-higher-remission-rates-in-type-2-diabetes.aspx XX Beta Bionics has set the terms for its plan to go public, with a goal of raising at least $114 million to support its artificial pancreas system for people with Type 1 diabetes. That’s as we’re recroding, it’s likely they will have begun trading on the NASDAQ by now.. the ticker is BBNX. Beta Bionics’ iLet system was first cleared by the FDA for people ages six and up with Type 1 diabetes in May 2023. The Fierce Medtech Fierce 15 winner has since expanded its blood sugar sensor compatibility to include Abbott’s FreeStyle Libre and Dexcom’s G6 and G7 platforms. The company also said it plans to pursue new clinical studies and an FDA clearance that would enable the iLet’s use among people with Type 2 diabetes. The ultmite goal is to have a dual-chambered pump with both insulin and glucagon.. but I didn’t find anything about that in the articles about this IPO.. I followed up with Beta Bionics and they told me that the dual chambered pump is still very much the goal. Not sure why most of the publications left that out.. but good to hear. https://www.fiercebiotech.com/medtech/artificial-pancreas-maker-beta-bionics-aims-raise-120m-nasdaq-ipo XX Large new study estimates the size of the current US population with type 1 diabetes and project growth over the next ten years. They say about 2 million live with type 1.. about 1.79 million adults and 290-thousand children. Growth in the ten years is predicted to be about 10% https://jheor.org/article/124604 XX The American Diabetes Association® (ADA) teams up with Xeris Pharmaceuticals® makers of Gvoke – ready to use emergency glucagon. It is estimated that up to 46% of people with type 1 diabetes and 21% of those with type 2 diabetes using insulin experience at least one severe hypoglycemia event each year.2 The ADA, with support from Xeris, seeks to rectify the low rates of appropriate glucagon prescriptions by developing education materials and training resources for health care professionals and people living with diabetes, as well as through a national awareness campaign to educate people on who is at risk for severe hypoglycemia and should have glucagon, preferably ready-to-use, as a safety net. https://www.prnewswire.com/news-releases/the-american-diabetes-association-and-xeris-pharmaceuticals-announce-national-collaboration-to-provide-life-saving-hypoglycemia-education-and-awareness-302355703.html XX XX Wearing a CGM makes pharmacy students better at counseling patients. New study randomly assigned students to wear a CGM during lab sessions.. those who did had a higher average counseling score during the encounter with a patient and a higher overall confidence score. There was also a statistically significant positive correlation between average confidence and average empathy, and empathy and counseling performance. https://www.drugtopics.com/view/hands-on-cgm-training-helps-student-pharmacists-prepare-for-career XX Mark Andrews Bills Mafia Baltimore Ravens tight end Mark Andrews received a host of negative attention after flubbing a potential game-tying two-point conversion in Sunday night's loss to the Buffalo Bills. In the face of the online rage, Bills Mafia is again showing some support. Bills fan Nicholas Howard kicked off a GoFundMe to back Breakthrough T1D, a global Type 1 diabetes research organization that Andrews has supported. "As many of you know, Ravens TE wasn't able to catch the game-tying 2-point conversion and upset Ravens fans," Howard wrote. "On top of that, the TE has been receiving death threats and nasty comments after his performance last night. We want Bills Mafia to donate to Marks charity for [Type 1] diabetes." As of Wednesday morning, the fund raised more than $50,000 for the charity. Related Links Lamar Jackson, Ravens bemoan missed opportunities in loss to Bills, defend Mark Andrews Ravens WR Zay Flowers: Missing 2024 playoff run due to injury 'took a little toll on me' Biggest winners and losers from Sunday's Divisional Round NFL playoff games The Ravens thanked Bills fans for supporting Andrews. "Shout out to Bills Mafia for showing support to our guy Mark Andrews and donating to the [BreakthroughT1D] organization, which works towards curing and improving the lives of those dealing with Type 1 diabetes," the club posted. Andrews was diagnosed with Type 1 diabetes as a child, an autoimmune disease for which there is currently no cure. He's one of several NFL players diagnosed with Type 1 -- Kansas City Chiefs tight end Noah Gray is another. "Breakthrough T1D [formerly JDRF] greatly appreciates the generosity of the Buffalo Bills community and the many fans who were compelled to donate after Sunday's game," the organization said in a statement to ESPN's Alaina Getzenberg. "These donations will support research and advocacy on behalf of the 1.6 million Americans who, like Mark Andrews, live with type 1 diabetes." It's not the first time that Bills fans have donated to the cause of a non-Buffalo player. Back in January 2018, Buffalo fans famously donated to the charity of former Cincinnati Bengals quarterback Andy Dalton after his win over Baltimore helped Buffalo make its first playoff appearance in nearly two decades. Over and over again, Bills Mafia has shown it will support a good cause when some spew hate. https://www.nfl.com/news/bills-fans-supporting-ravens-te-mark-andrews-after-drop-by-donating-to-type-1-diabetes-research /episode/index/show/diabetesconnections/id/34987225

Pregnancy, T1D, and Unexpected Challenges: Lauren Bongiorno shares her story 01/21/2025

What does “Smart MDI” really mean? A deep dive into Medtronic’s new InPen™ app 01/14/2025

In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more! 01/10/2025

In the News... BIG beta cell transplant news, a new pump team-up, FDA moves on GLP-1 compounds, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more. Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success. This is very early and hasn’t yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin. Sana’s CEO says “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.” I’ve reached out to Sana to get more on this.. love to talk to them soon. XX FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). Studies showed a meaningful reduction in A1C but a meaningful increase in DKA. The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD. Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors. According to Lexicon, Inpefa will continue to be manufactured and made available to patients. XX Two companies we’ve been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They’ve announced a new partnership agreement. From the release: Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor." Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed. XX Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device. XX Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems. There’s a long history here – UVA is where the Control IQ algorithm was developed. This agreement seems to keep the team together for another decade. https://www.businesswire.com/news/home/20250107162995/en/Tandem-Diabetes-Care-Enters-Multi-Year-Research-Collaboration-with-UVA-Center-for-Diabetes-Technology-for-Development-of-Advanced-Insulin-Delivery-Systems XX New study says insulin is still the best treatment for gestational diabetes, compared to oral glucose-lowering medications. Metformin and gluburide are being closely looked at since they're easier to administer, less costly, and have better acceptance among patients. But this study says insulin was a bit better – slight more babies were born larger for the metformin group, and more moms had hypoglycemia. XX In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza. Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding. XX Bit of an update on compounded terzepatide and semaglutide. The FDA is allowing a grace period of 60 days before starting to enforce the end of allowing compounds of Mounjaro. Meanwhile, semaglutide remains on the FDA’s shortage list for several dose strengths, though all doses have been reported as “available” since late October 2024. Compounding pharmacies, especially larger 503B “outsourcing facilities,” maintain they provide an essential public service by offering lower-cost versions of medications that can cost over $1,000 per month. Many insurers still refuse to cover brand-name GLP-1 products for weight loss. Yet the FDA has reported hundreds of adverse event reports allegedly linked to compounded versions of these drugs, which do not undergo the same rigorous manufacturing inspections and clinical testing as approved brands. https://www.drugdiscoverytrends.com/compounders-and-drugmakers-clash-over-compounded-weight-loss-drugs-with-fda-in-the-middle/ XX Interesting story here.. this study says a fecal transplant can help people with type 1 and severe gastroenteropathy. The researchers say diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited. Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention. After four weeks, Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome. XX A couple of weeks ago, listeners told me that the Dexcom geofencing issue we reported on seems to be resolved. Dexcom is now confirming this. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn’t reinstall or use the app without customer support. As of last month, the geofencing issue has now been resolved with the latest Dexcom G7 2.6 app update. XX Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead the U.S. market for CGMs, agreed on Dec. 20 to resolve all outstanding patent disputes and not sue each other over patents for 10 years. Dexcom and Abbott previously reached a settlement in 2014 related to their diabetes devices, which included a cross-licensing deal and an agreement not to sue each other until 2021. After that agreement expired, the companies filed a volley of patent lawsuits. /episode/index/show/diabetesconnections/id/34795510

T1D Tech Trends: VIVI Smart and what we’re watching at the Consumer Electronics Show 01/07/2025

What’s next for type 1 diabetes? A look ahead to 2025 with Dr. David Ahn 12/31/2024

The Top Ten T1D Stories of the Year: A look back at our 2024 episodes 12/24/2024

In the News... Inhaled Insulin Studied for Kids, Dexcom Launches AI, App for Driving & T1D, and more! 12/20/2024

In the News... Inhaled Insulin Studied for Kids, Dexcom Launches AI, App for Driving & T1D, and more! It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin. A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing. HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, There were no differences between groups or concerns in other safety measures, including hypoglycemia. https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex XX Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health. Stelo users will start seeing the features this week. The AI is modeled after Google Cloud’s Vertex AI and Gemini models. We’ll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare. BTW this press release is the first time I’ve seen what seems to be a new slogan for Dexcom – Discover What You’re Made Of. https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing XX Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn’t reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention. XX Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company. The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa. Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges. This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030. https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html XX Can we add treating sleep apnea to the list of applications for terzepatide? That’s the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea. Eli Lilly said there was nearly a 20% reduction in weight among those in the trials. The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year. XX Health Canada okays Tandem’s tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors. Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7’s 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4. Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025. To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca. XX A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps. The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision. Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps. In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million. A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe’s Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea. The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet’s trade secrets. Insulet CEO Jim Hollingshead said the company is “extremely pleased with the jury’s verdict.” EOFlow did not immediately respond to a request for comment. https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/ XX A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds. Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions. Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care. https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes XX New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable. In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them. We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support. For more information, please visit: XX I’m also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2. XX That’s it for the last In the News of 2024! Don’t miss out episode next week with a look ahead to what we’re watching in 2025. I’m SS I’ll see you back here soon… /episode/index/show/diabetesconnections/id/34541065

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Diabetes Connections | Type 1 Diabetes

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