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