Inside the class-action lawsuit against insulin pricing, with Attorney Steve Berman

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: iPhone control for Omnipod 5 rolls out, Libre is approved for use in CT scans and MRIs, Dexcom files for 15 day wear, Luna nighttime pump goes to trial, iLet cell trials move forward and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] 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 Insulet Corporation announces the full market release of the Omnipod 5 App for iPhone® in the U.S. App allows users to fully control their Omnipod 5 Automated Insulin Delivery System (Omnipod 5) from their compatible iPhone1. For example, users can bolus for a meal, change a Pod, and adjust settings. Importantly, this also means that Omnipod 5 users who have a compatible iPhone no longer need to carry a separate Controller to help manage their insulin delivery requirements. Insulet says that the App for iPhone has been the number one feature requested by Omnipod 5 users. The Omnipod 5 App for iPhone is currently compatible with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and is expected to be compatible with the Dexcom G7 CGM in the U.S. in 2025. The Omnipod 5 App for Android phones is also available to U.S. customers. https://www.businesswire.com/news/home/20241029838744/en/Omnipod%C2%AE-5-App-for-iPhone%C2%AE-Now-Fully-Available-in-the-United-States   XX Th FDA says it’s okay to keep on your FreeStyle Libre 2 and 3 for procedures like X-rays, CT scans and MRIs. Abbott said it makes its systems the first and only patient-applied CGM sensors approved for these screenings. Imaging procedures often come as part of diabetes care, Abbott said, especially as diabetes can cause a number of medical complications. The company rigorously tested its Libre 2 and 3 sensors to ensure they remain effective after radiologic procedures. This FDA clearance comes with no changes made to the sensor.   https://www.drugdeliverybusiness.com/fda-approves-abbott-cgms-medical-imaging/ XX Tidepool announced a new data integration with Abbott for the company’s FreeStyle Libre continuous glucose monitors (CGMs). The companies aim to deliver cloud-to-cloud integration for an automatic stream of data from patients using Abbott’s CGMs in the U.S. Data streams to Tidepool+, a diabetes data visualization and population health platform. Tidepool+ provides intuitive tracking and visualization of diabetes data to make the data informative and actionable for clinicians, people with diabetes and caregivers. https://www.drugdeliverybusiness.com/tidepool-abbott-data-integration-freestyle-libre/ XX Beta Bionics announced today that it launched the integration of the iLet bionic pancreas with the Abbott (NYSE:ABT) FreeStyle Libre 3 Plus. The companies announced their plan to combine the FreeStyle Libre 3 Plus continuous glucose monitor (CGM) with iLet last month. According to Beta Bionics, this makes iLet the first available automated insulin delivery (AID) system to integrate with Libre 3 Plus in the U.S. iLet users can now update their app and software to gain a choice of integrated CGMs. They can choose between Libre 3 Plus and Dexcom CGMs.   Abbott, meanwhile, continues to push forward on the automated insulin delivery integration front. The company recently paired its FreeStyle Libre 2 Plus with Insulet’s Omnipod 5 in Europe. It also announced compatibility with the Tandem Diabetes Care t:slim X2 system in January.   Notably, the company also struck a deal with Medtronic in August. They aim to develop CGMs specifically for the medtech giant’s own insulin delivery systems. https://www.drugdeliverybusiness.com/beta-bionics-launches-ilet-abbott-libre/ XX Dexcom is asking the FDA to approve the G7 CGM for 15 days. Right now the G7 has a 10 day wear time.  Dexcom also launched the G7 CGM in Australia and rolled out Dexcom ONE+ in France. Some front-office news.. EVP and CCO Teri Lawver plans to retire at the end of the year. https://www.drugdeliverybusiness.com/dexcom-submits-15-day-cgm-fda-q3-2024/ XX Stelo by Dexcom is one of TIME’s Best Inventions of 2024! As the first glucose biosensor available in the U.S. without a prescription, Stelo has unlocked our industry-leading technology for millions of people across the U.S. looking to improve their health through personalized insights. We’re honored to be recognized among other unique innovations in the Home Health category that support people’s health. https://time.com/7094684/dexcom-stelo/   XX   Luna Diabetes is moving forward with a pivotal trial evaluating its automated closed-loop insulin technology, the Luna System. This is designed to address nighttime glucose control for insulin pen users. It’s meant for use only during sleep - Luna system was developed as a wearable insulin pump and alternative to insulin pen to automate the insulin delivery process. The device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. Luna Diabetes expects the study to be completed early next year, with plans to commercially launch the device “soon after”.   https://finance.yahoo.com/news/luna-diabetes-trials-automated-wearable-115211566.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAJIrWwjdye-ehrLNDt-LIGb5qTXaKDTIa8NWwiT7fKwFFgjDMN2nnINis6YfFePWP2ZA2DVYWXEIZQqRlQ4aKLFrYWgvw1jdI-t1n9kO6NIzdBCMXQNNCVl_S-75lDNip2SysHDJQmyqSc4wLjfDya3v9wwTWU-KgE_OqrPCTnlu XX Researchers are urging  caution when prescribing off-label glucose-lowering drugs to individuals with type 1 diabetes (T1D) while acknowledging that doctors keep prescribing them because they seem to work so well. Both glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown significant benefits for cardiovascular and renal health in other populations, particularly in patients with type 2 diabetes.   SGLT2 inhibitors carry a significant risk of euglycemic diabetic ketoacidosis, a dangerous condition most common in T1D individuals where toxic levels of blood acidification can occur. Due to this risk, SGLT2 inhibitors were removed for T1D use in Europe, and the U.S. Food and Drug Administration (FDA) has not approved them for T1D.   For GLP-1RAs, there are concerns about substantial weight loss potentially leading to ketoacidosis or worsening hypoglycemia. While these medications can be beneficial in managing weight, the extent of that weight loss can create new problems in people with T1D as their insulin needs may quickly change as a result. Prescribing in People With Type 1 Diabetes," published in JAMA, the authors stress the critical need for more research to confidently allow the off-label usage of potentially dangerous secondary treatments. The data suggests clinicians are turning to these treatments to manage cardiovascular and renal complications in T1D patients, even though the drugs are not explicitly approved for this condition.   Conversely, those newly prescribed GLP-1RAs had higher rates of obesity (69.4% vs. 45.7%). This data indicates that clinicians are prescribing GLP-1RAs to help manage obesity in T1D patients, as weight management is a critical component of diabetes care.   The percentage of the T1D population prescribed GLP-1RAs increased significantly, from 0.3% in 2010 to 6.6% by 2023. The percentage prescribed SGLT2 inhibitors rose from 0.1% in 2013 to 2.4% by 2023. Overall, the percentage of T1D patients prescribed either of these medications increased from 0.7% to 8.3% during this period.     Results of the study suggest that despite regulatory concerns, off-label use of GLP-1RAs and SGLT2 inhibitors in T1D continues to grow primarily due to their cardiorenal and weight management benefits.   "Prospective studies on the efficacy and safety of GLP-1RAs or SGLT2 inhibitors in the T1D population are needed," the Research Letter concludes, "Before such evidence becomes available, caution should be exercised when prescribing these treatments to individuals with T1D."   https://medicalxpress.com/news/2024-10-glucose-lowering-drugs-diabetes-patients.html XX More good islet transplant news.. from Eledon Pharmaceuticals and University of Chicago. These are potentially the first human cases of insulin independence achieved using a transplant of insulin-producing islet cells in combination with its experimental immunosuppressant drug. The first two subjects achieved insulin independence and normal hemoglobin A1C (HbA1c) levels, a measure of average blood glucose, post-transplant. The third subject, who recently received an islet transplant, decreased insulin use by more than 60% three days following the procedure and continues on an insulin independence trajectory. Some of the funding for this study comes from Breakthrough T1D. https://www.globenewswire.com/news-release/2024/10/29/2970713/0/en/Eledon-Pharmaceuticals-Announces-Positive-Initial-Data-from-Subjects-with-Type-1-Diabetes-Treated-with-Tegoprubart-as-Part-of-an-Immunosuppression-Regimen-Following-Islet-Transplan.html XX   Semaglutide may reduce Alzheimer’s risk in type 2 diabetes patients, with research suggesting significant protective benefits compared to other diabetes drugs. published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, the study suggests that T2D patients taking semaglutide had a significantly lower risk of developing Alzheimer’s. This effect was observed consistently across various subgroups, including differences in obesity status, gender, and age. Semaglutide, which acts on glucagon-like peptide receptors (GLP-1R) to curb hunger and regulate blood sugar in T2D, is also the active component in the diabetes and weight-loss drugs Wegovy and Ozempic. About 120,000 Americans die from Alzheimer’s disease each year, with the disease listed as the seventh-leading cause of death nationally, according to the CDC. https://scitechdaily.com/alzheimers-breakthrough-popular-diabetes-drug-ozempic-linked-to-much-lower-risk/ XX   XX Edgepark commercial XX Apple’s non invasive blood glucose monitoring rumors are back. But this sounds like just software.. no watch or hardware. According to the report, Apple doesn't currently have plans to release the app, but may integrate the technology into its future health products. The app could reportedly show consumers how certain foods impact their blood sugar levels, based on measurements taken by existing blood sugar monitoring devices. One report says apple is exploring uses for blood sugar data and what tools they could create for consumers as a result. Latterly, he reports testing on the app has been paused, but says the tests could pave the way for better food tracking on Apple's own health software or better third-party glucose tracking integration. https://www.techradar.com/health-fitness/apple-is-testing-a-new-blood-sugar-product-but-its-not-the-apple-watch-update-weve-been-waiting-for XX And finally, it’s diabetes awareness month. Please follow on social – I’ll be doing a few things but mostly I think this month is great to educate the general public.. every month is diabetes month for this community. XX J

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Hurricane aid for people with diabetes, Medtronic safety warning, stem cell updates for type 1, new study about teens and young adults with type 1, and Ryan Reed returns to racing. Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] 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 Hurricane Insulin efforts XX Medtronic has notified customers that battery issues with its Minimed 600 and 700 series insulin pumps could cause the devices to stop delivering insulin significantly sooner than expected. A “low battery pump” alert, intended to signal up to 10 hours of remaining battery life, may be displayed on the device even if much less time is left. Medtronic told customers they could contact the company to determine the need for a replacement pump. Medtronic said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S., from January 2023 to September 2024, potentially related to the issue. Pump models including the Minimed 630G, 670G, 770G and 780G systems are affected by the notice. https://www.medtechdive.com/news/Medtronic-Minimed-insulin-pumps-recall-battery-life/729019/ XX A woman has undergone a stem-cell therapy made from her own cells, to treat her type 1 diabetes. Researchers in China discovered the woman did not need to use insulin 75 days after the procedure, and that the stem-cell derived islet cells she was injected with had been engrafted inside her abdomen. the case is the first of its kind, and two more people have been enrolled in the clinical trial in China since, researchers involved in the study told Medical News Today. Other stem-cell based therapies for type 1 and type 2 diabetes are also currently in development and in trials. For this case study, researchers based in Tianjin First Central Hospital, Nankai University, Tianjin, China took fat cells from a 25 year-old woman with type 1 diabetes, and chemically induced them to behave as pluripotent stem cells, a type of cell that can develop into other types of cell. They then used these to create islet cells, which typically exist in the pancreas and create insulin, a hormone that regulates levels of glucose (sugar) in the bloodstream. The patient in this case study had previously had two liver transplants and a failed pancreas transplant due to complications that had arisen due to her diabetes. The induced islet cells made from the patient’s own cells were then injected between the skin and abdominal muscles. Researchers discovered that these successfully engrafted in the patient, including growing their own vasculature. Before the procedure she produced enough insulin to reach her target glycemic range 43.18% of the time, and 4 months later this increased to 96.2% of the time. She was also shown to have lower glycated hemoglobin, which indicated long-term systemic glucose levels at a non-diabetic level.   https://www.medicalnewstoday.com/articles/stem-cell-therapy-reverses-type-1-diabetes-in-groundbreaking-case-study XX The state of Texas is accusing major pharmacy benefit managers and drug companies of colluding to raise the cost of insulin.   Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs Optum Rx, Express Scripts and CVS Caremark through a quid pro quo agreement. PBMs then give preferred status on its standard formularies to drugs with the highest list prices, the state said. Insulin costs $2 to produce and could be purchased for $20 in the 1990s but now costs up to $700, the Office of the Attorney General of Texas wrote in a news release. The filing goes so far as to describe a LinkedIn group these executives would use to discuss insulin pricing tactics. The Federal Trade Commission (FTC) recently sued Optum Rx, Express Scripts and Caremark for rising insulin prices and anticompetitive practices. The PBMs reject the FTC’s findings. Drug manufacturers were not included in the lawsuit. Texas’ lawsuit also noted the consolidation in the PBM market, arguing it gives PBMs a “disproportionate amount of market power.” Nearly 40 PBM entities have now been consumed by UnitedHealth Group, Cigna and CVS Caremark. https://www.fiercehealthcare.com/payers/texas-sues-pbms-manufacturers-over-insulin-conspiracy XX Canadian teens and young adults living with diabetes face double the risk of hospitalizations and emergency room visits compared with younger children with the condition, say doctors suggesting changes to how care is organized for affected families. In the October issue of the journal The Lancet Diabetes and Endocrinology, Dr. Meranda Nakhla, a pediatric endocrinologist at the Montreal Children's Hospital, and her team used Quebec health administrative data to estimate the risk of gaps in regular diabetes care for complications in children under 10, and adults up to age 23.   "With adolescents and young adults, [the complication]  tends to be more related to an insulin omission and maybe just feeling burnt out from having diabetes and just not wanting to deal with it," Nakhla said. "They may stop taking insulin and a day later end up in the emergency room with diabetic ketoacidosis." Part of the challenge, Nakhla said, is for parents to take a step back from managing all aspects of their child's diabetes to a more supportive role that allows the child to have more autonomy. What's new about the Quebec findings is they highlight how gaps in diabetes care visits start at a younger age than previously looked at, said Dr. Rayzel Shulman, a pediatric endocrinologist at Toronto's Hospital for Sick Children. Since the brains of adolescents and young adults aren't fully developed, planning ahead, thinking about the consequences of their actions and controlling impulses differs from their parents. As part of an ongoing study, Shulman's team uses text messages to send adolescents and young adults appointment reminders as well as monthly diabetes messages. They recently added an artificial intelligence chat bot programmed with answers from trusted sources. https://www.cbc.ca/news/health/diabetes-pediatric-1.7345526 XX A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs.   On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lily, had a manufacturing capacity that “can meet the present and projected national demand.”     With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association (OFA) represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders.   The OFA and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the FDA on Monday, alleging the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”   “Ignoring evidence that the shortage persists, FDA removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” said their complaint.   The evidence that the plaintiffs cited for the shortage persisting was that the FDA noted in its announcement that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”   Eli Lilly made a similar statement after the shortage was declared over, saying, “Patients’ experiences looking for a particular dose of medicine in their local pharmacies may vary. The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. ” https://thehill.com/policy/healthcare/4922234-trade-group-sues-fda-over-ending-mounjaro-zepbound-shortage/ XX New project in Europe to provide data to enable more people with diabetes who use insulin to work as commercial pilots and air traffic controllers. The European Union Aviation Safety Agency project focuses mainly on pilots and air traffic controllers, but the data being collected will apply to cabin crew and passengers with diabetes as well   currently only three countries in Europe — the United Kingdom, Ireland, and Austria — allow them to obtain a license that enables them to fly commercially, under a strict protocol that was first launched by the UK Civil Aviation Authority in 2012. The Irish Aviation Authority joined in 2015, and Austro Control followed in 2016.     https://www.medscape.com/viewarticle/eu-program-aims-ensure-safety-pilots-who-use-insulin-2024a1000ia6 XX Edgepark commercial XX The two-time Xfinity Series winner was competing at Talladega in McAnally-Hilgeman Racing’s No. 91 truck for his first start of the season. The last time Reed drove in a NASCAR event came last fall at Las Vegas Motor Speedway in the Xfinity Series, and his most recent Truck start came in the spring of 2021 at Darlington Raceway.   “I couldn’t stop making mistakes early on,” Reed said. “The truck was so fast. I think more than anything I’m really proud of myself for being able to get out there and make aggressive pushes and be able to kind of rise to the occasion.”   See also Grant Enfinger Wins Talladega, Advances to Championship 4 Despite the speed, Reed’s truck burst into flames shortly after crossing the finish line. Reed said he stared at the door of teammate Christian Eckes while he crossed the line in the middle of a multi-truck pileup.     “Gosh, we could go anywhere we wanted today,” Reed told Frontstretch. “I made a lot of mistakes, but we put ourselves in position at the end. I hate that Bill [McAnally] has torn up race trucks.”   Friday marked Reed’s sixth start in the past six years in Truck and Xfinity equipment, something Reed said might have added some doubt.   “When you’re sitting on the couch every weekend, you think you can do it,” he reflected. “I remember I used to race every single weekend, I know how to get around these plate tracks, but you don’t know, right?   “It’s really gratifying to come off the couch and remind myself, like ‘hey I can still do this,’ at least at superspeedways. I think I can do it at other tracks too.”     The day ended in a combination of a career-best Truck Series finish and a ball of fire for Ryan Reed in his return to NASCAR Craftsman Truck Series competition on Friday (Oct. 4).   https://frontstretch.com/2024/10/04/ryan-reed-scores-career-best-finish-in-truck-series-return/ XX Join us again soon!

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FTC sues PBMs over insulin pricing, a new CGM is approved in Europe, more news about GLP-1s but some research says it may not work as well for one population, diabetes camps are invited to apply for grants, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] 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 The U.S. Federal Trade Commission sued the country's three largest pharmacy benefit managers on Friday, accusing them of steering diabetes patients towards higher priced insulin in order to reap millions of dollars in rebates from pharmaceutical companies. The case accuses UnitedHealth Group Inc's (UNH.N), opens new tab Optum unit, CVS Health Corp's (CVS.N), opens new tab CVS Caremark and Cigna Corp's (CI.N), opens new tab Express Scripts of unfairly excluding lower cost insulin products from lists of drugs covered by insurers. The three companies said in statements that the suit was baseless and defended their business practices, saying that they had lowered insulin prices for businesses, unions and patients. https://www.reuters.com/business/healthcare-pharmaceuticals/us-ftc-sues-drug-gatekeepers-over-high-insulin-prices-2024-09-20/ XX A new study finds metformin, may slow aging. Previous studies on "lower order" species have found that it can delay the onset of age-related diseases.  Gotta say, this is only in animal studies right now, not people, human trials are next. https://www.cbsnews.com/boston/news/diabetes-drug-metformin-aging/ XX New research from the Case Western Reserve University School of Medicine identifies a potential new approach to address the opioid overdose epidemic—which has devastated families and communities nationally.   The study, published in the journal JAMA Network Open, suggests semaglutide is linked to lower opioid overdoses in people with opioid-use disorder (OUD) and type 2 diabetes (T2D).   Semaglutide, a glucagon-like peptide receptor (GLP-1R) molecule that decreases hunger and helps regulate blood sugar in T2D, is also the active component in the diabetes and weight-loss drugs Wegovy and Ozempic.   The research team—led by biomedical informatics professor Rong Xu—analyzed six years of electronic records of nearly 33,000 patients with OUD who also had T2D. The researchers used a statistical approach that mimics a randomized clinical trial.   They found patients prescribed semaglutide had a significantly lower risk for opioid overdose, compared to those who had taken any of eight other anti-diabetic medications, including other types of GLP-1R-targeting medications.   About 107,500 people died from drug overdoses nationally in 2023, mostly from opioids, according to the CDC. Despite effective medications to prevent overdoses from OUD, the CDC estimates only a quarter of those with OUD receive them and about half discontinue treatment within six months. https://medicalxpress.com/news/2024-09-popular-diabetes-weight-loss-drug.html XX New research analyzing the effects of two drugs used to treat type 2 diabetes indicates a consistent lack of cardiovascular and renal benefits in Black populations. The drugs, called sodium-glucose co-transporter 2 inhibitors (SGLT2-Is) and glucogen-like peptide 1 receptor agonists (GLP1-RAs), are some of the newer treatments prescribed to lower blood sugar levels in people with type 2 diabetes. The research findings, published in the Journal of the Royal Society of Medicine, show that for White and Asian populations, SGLT2-Is and GLP1-RAs have beneficial effects on blood pressure, weight control and renal function, and significantly reduce the risk of severe heart problems and kidney disease. However, the research shows no evidence of these beneficial effects in Black populations. ""Whether the differences are due to issues with under-representation of Black populations and low statistical power, or to racial/ethnic variations in the way the body and these drugs interact with each other needs further investigation," said Professor Seidu. "It is therefore important that prescribers don't hasten to deny these newer treatments to Black populations on the back of this research." https://www.news-medical.net/news/20240923/Research-reveals-disparities-in-diabetes-drug-efficacy-for-Black-populations.aspx XX If a woman is already in a "prediabetic" state in her teen or college years, her odds for a serious complication of pregnancy later in life rises, new research shows.   Ignoring prediabetes in teenagers "may represent a missed opportunity to avert pregnancy-related complications" later, said study lead author Katharine McCarthy. She's an assistant professor of population health science and policy, and obstetrics, gynecology and reproductive science at the Icahn School of Medicine at Mount Sinai in New York City.   Her team published its findings Sept. 24 in the journal JAMA Network Open. Prior research has found that rates of prediabetes have tripled among Americans ages 12 to 19 over the past decade. In the new study, the Mount Sinai team tracked rates of prediabetes (using blood sugar tests) among a group of 14,000 New York City residents ages 10 to 24. None of these individuals had full-blown diabetes at the time they were tested.   Having prediabetes in youth was linked to a doubling of risk of gestational diabetes -- new-onset diabetes while pregnant. Tracking blood levels of hemoglobin A1c, a measure of a person’s average blood sugar level over the prior three months, was very predictive of whether or a not a woman would get gestational diabetes, the team found.   Prediabetes in youth was also linked to an 18% rise in the risk for hypertensive disorders during pregnancy, such as gestational hypertension and preeclampsia, or preterm delivery.   Measuring a teen girl's blood for signs of prediabetes might help protect her against trouble in a later pregnancy, McCarthy's group said. https://www.usnews.com/news/health-news/articles/2024-09-24/prediabetes-in-teens-could-raise-odds-for-complicated-pregnancies-later XX Is there a link between IBD and type 1? In a recent and very large study, researchers looked at more than 630-thousdan people and found that irritable bowel disease seemed to significantly increase the risk of type 1 diabetes and vice versa. Interestingly, patients with IBD were found to have a significantly higher probability of formerly having contracted T1D, validating the bidirectional associations between these comorbidities. The highest risk was observed in patients with ulcerative colitis (aHR = 2.02), highlighting a stronger association with this IBD subtype. Additionally, over 70% of the study cohort was followed for more than ten years, reinforcing the robustness of these findings. https://www.news-medical.net/news/20240919/IBD-increases-type-1-diabetes-risk-revealing-a-bidirectional-link-between-the-two-conditions.aspx XX Roche plans to launch its first continuous glucose monitor (CGM) in Europe “in the coming weeks,” The Accu-Chek Smartguide has European approval for adults with Type 1 or Type 2 diabetes. Roche will roll out the CGM in the Netherlands, Switzerland and Germany. Accu-Chek Smartguide can be worn for 14 days, and features predictive algorithms that Roche hopes will differentiate it from competitors Abbott and Dexcom. However, it also must be calibrated at first using a finger stick, which the other brands don’t require.   Roche developed the CGM with three different prediction tools: A feature to predict the risk of low blood glucose within 30 minutes, a feature to forecast glucose levels over the next two hours, and a feature to predict hypoglycemia risk at night.   Pau Herrero, an algorithm and decision support tech lead at Roche, said the device provides a different picture than the trend arrows other CGMs use, which typically forecast glucose levels over the next 20 minutes. The predictions are based on multiple days of patient data using machine learning models. The company is in “active discussions” with the Food and Drug Administration on bringing Accu-Chek Smartguide to the U.S., Moreiras said, adding that he “cannot commit to any timelines.” https://www.medtechdive.com/news/roche-cgm-launch-europe/726863/ XX Exciting news! iLet users can now invite friends and family to join their Bionic Circle to see their diabetes data and receive alerts. By accepting the invite and downloading our new Bionic Circle App, loved ones can monitor an iLet user’s CGM values, meal announcements, insulin doses, and alerts from anywhere.   To learn how to invite followers and accept an invite, visit: https://lnkd.in/ghigJKMt XX Diabetes Canada has unveiled the key findings of a first-of-its-kind national survey on how widespread stigma, judgement and discrimination is for those who live with diabetes and the impact of those social experiences on the quality of life for people with diabetes. The survey shows that diabetes can not only negatively impact a person’s physical health but can also negatively affect their personal relationships, work or studies, leisure activities, financial situation, and emotional well-being.   In fact, nearly 90% of people living with type 1 diabetes and 70% of people living with type 2 diabetes experience shame and blame for having diabetes.   “As someone who lives with type 2 diabetes, I know first-hand how stigma can negatively impact the quality of life for people living with this condition in Canada,” says Laura Syron, President & CEO of Diabetes Canada. “We need to change the conversation around diabetes—the values, beliefs and language—so that people living with this condition can feel more accepted and understood. These feelings can dramatically improve the likelihood that people living with diabetes can receive the support and care they need to better their health outcomes and their quality of life.” In the survey, key findings show how people living with diabetes must deal with unfair assumptions about what they can and cannot do, judgements if they consume specific foods, and being blamed for having diabetes. 40% of people with T1D never or rarely ask for support to help manage their diabetes when they need it.   56% of people with T2D never or rarely ask for support to help manage their diabetes when they need it.   https://finance.yahoo.com/news/diabetes-canada-releases-first-kind-101300695.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAJIrWwjdye-ehrLNDt-LIGb5qTXaKDTIa8NWwiT7fKwFFgjDMN2nnINis6YfFePWP2ZA2DVYWXEIZQqRlQ4aKLFrYWgvw1jdI-t1n9kO6NIzdBCMXQNNCVl_S-75lDNip2SysHDJQmyqSc4wLjfDya3v9wwTWU-KgE_OqrPCTnlu XX Edgepark commercial XX This is National Glucose Awareness Week. Dexcom and Beyond Type 2 are teaming up for the new designation to encourage people to learn about the importance of glucose and its significant impact on overall health, especially for people with diabetes. The news release says: National Glucose Awareness Week will feature a variety of educational resources about the importance of glucose health and information about new, cutting-edge glucose biosensing technology. That technology is CGM.. now available over the counter as Dexcom’s Stelo. Get moving: Participate in a nationwide step challenge (invitation code: glucose) from Sept. 30 to Oct. 13 to help improve your glucose health.† Step challenge participants can register to participate from Sept. 23-29, 2024 and will have the chance to compete for prizes. Get resources: Close the glucose knowledge gap with key educational resources from Beyond Type 2. https://www.businesswire.com/news/home/20240923896101/en/Dexcom-Beyond-Type-2-and-Retta-Establish-National-Glucose-Awareness-Week-to-Close-the-Glucose-Knowledge-Gap?utm_campaign=shareaholic&utm_medium=copy_link&utm_source=bookmark   XX Attention diabetes camp organizers! You’re invited to apply for financial support for your need based scholarships. This is the Type 1 Diabetes Camps Project: 2025-2027 Campership Initiative The initiative will also provide limited funds for selected camps to expand their revenue development efforts, funds for professional development and funds for low-income camper recruitment efforts and indirect costs. The initiative is supported by $6 million in grant funding from The Leona M. and Harry B. Helmsley Charitable Trust and $900 thousand in funding from Eli Lilly and Company over the next three years. For more information about the RFP, please login and navigate to the publicly available RFPs: https://newventurefund.force.com/login XX Join us again soon!

Automated insulin delivery has been an incredible advancement for insulin pumps. Now, for the first time, the FDA has approved a system for people with type 2. It’s called Omnipod 5. We’re going to talk about how it works, who it helps, and what the company found in their studies of people who use it. My guest this week is Dr. Trang Ly, truly one of the pioneers of studying and innovating around automated insulin delivery – or AID – systems. She is the Medical Director at Insulet, the company that makes Omnipod.  Prior to joining Insulet, Dr. Ly served as Clinical Assistant Professor in the Division of Pediatric Endocrinology, Stanford University School of Medicine. Dr. Ly began her career as a Pediatric Endocrinologist in the Department of Endocrinology and Diabetes at Princess Margaret Hospital for Children in Perth, Australia. Learn more about Omnipod 5 for type 2 This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected]

For the first time, you can buy a continuous glucose monitor over the counter, no prescription needed. This summer we went from no CGMs available this way, to now having two. This week we’re talking about the Dexcom Stelo with the company’s COO Jake Leach. We’ll go through the features, the price, how to order and what you should know before you start a CGM. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More information about Stelo from Dexcom here  Our previous episodes on Stelo here Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected]

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

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FDA approved Omnipod 5 for people with type 2 who use insulin, Dexcom's Stelo, the first over the counter CGM, is now on sale. more evidence that bright light at night may increase the risk of diabetes, a price cut for Zepbound, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX In a first for any automated insulin delivery system, The FDA clears Omnipod 5 for people with type 2 diabetes. The new indication is based on data from the real-world multicenter SECURE-T2D trial of a racially diverse group of 305 adults with type 2 diabetes who were taking insulin. About half were also taking a glucagon-like peptide-1 (GLP-1) receptor agonist. Use of the Omnipod 5 resulted in a significant A1c reduction from 8.2% at baseline to 7.4% at 13 weeks (P Some doctors are already prescribing the Omnipod 5 off-label to some of their patients with type 2 and other types of diabetes. Private insurance will typically cover it, although prior authorization is often required. Medicare Part B requires certification of C-peptide deficiency for coverage of insulin pumps. This new indication is likely to increase uptake of the Omnipod 5 into primary care, where the vast majority of people with type 2 diabetes are managed. https://www.medscape.com/viewarticle/fda-clears-omnipod-5-system-type-2-diabetes-2024a1000fld XX For the first time, you can get a CGM over the counter, with no prescription. Dexcom began selling Stelo this week.. intended for people with Type 2 diabetes who don’t take insulin, although it can be used by people without diabetes. It costs 99 dollars for a one-time order of two sensors or $89 dollars for a monthly prescription. Stelo is a 15-day sensor based on Dexcom’s other glucose monitors. The main difference from prescription products is in what information users get through the app. Stelo flags glucose spikes, provides information on time-in-range goals, and includes meal and activity logging. The intent is to reveal how food, exercise and sleep can affect a person’s glucose levels. Competitor Abbott plans to launch two over-the-counter CGMs: one called Lingo, for people without diabetes, and one called Libre Rio, for people with diabetes who don’t use insulin. It has not yet priced either sensor. Abbott said it plans to debut its competing Lingo device this summer. The company has not said when it will launch its Rio CGM. https://www.medtechdive.com/news/dexcom-sells-stelo-over-the-counter-cgm/725310/ XX You’ll soon be able to get vials of Lilly’s popular weight loss drug, Zepbound, from a direct to consumer website, at a lower cost. This is still nearly 400 dollars a month for the lowest dose $550 for the next lowest and it will come in vials, not pens. Lilly and Novo have been struggling to make enough of their obesity medications to meet soaring demand, especially keeping up the pen supply. Lilly's medicines are now listed as available by the U.S. Food and Drug Administration, though they are not yet off the FDA's official shortage list where they have been most of the year. I haven’t seen this mentioned in any of the reporting but.. if it’s coming in a vial, you have to use a syringe to inject. Not much of a barrier to this group listening.. but pens have made using drugs like this much easier for a lot of people and I worry that going back to syringes is better for these companies than the patients. Zepbound is terzepatide, the same mediation as in Mounjaro. The latter is approved for people with type 2 diabetes, so this could be a way for some people to better access Mounjaro which is very hard to come by. https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-launches-single-dose-vials-zepbound-weight-loss-expand-us-supply-2024-08-27/ XX In a few months the US govermet will announce the list of 15 moe drugs they’ll negotiate Medicare prices for.. and Ozempic is a top candidate. This is speculation from Wall Street analysts but I think worth watching. All the drugs on their prediction list have been on the market since at least 2017 and are among those that the Medicare health program spends the most on. Under President Joe Biden's signature Inflation Reduction Act (IRA), prices for 10 highly popular prescription drugs used by Medicare will be cut by 38% to 79% in 2026. The industry has fought the negotiation program, saying it will stifle innovation. Government researchers predict that the use of diabetes drug Ozempic for weight loss would raise the U.S. deficit over the next 10 years at its current price. Medicare spent over $4.6 billion on the drug in 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/ozempic-wall-streets-list-2027-medicare-drug-negotiations-2024-08-23/ XX Type 2 diabetes and prediabetes are associated with accelerated brain aging, according to a new study from Karolinska Institutet in Sweden published in the journal Diabetes Care. The good news is that this may be counteracted by a healthy lifestyle. Type 2 diabetes is a known risk factor for dementia, but it is unclear how diabetes and its early stages, known as prediabetes, affect brain aging in people without dementia. Now, a comprehensive brain imaging study shows that both diabetes and prediabetes can be linked to accelerated brain aging. The study included more than 31,000 people between 40 and 70 years of age from the UK Biobank who had undergone a brain MRI scan (magnetic resonance imaging). The researchers used a machine learning approach to estimate brain age in relation to the person's chronological age.   Prediabetes and diabetes were associated with brains that were 0.5 and 2.3 years older than chronological age, respectively. In people with poorly controlled diabetes, the brain appeared more than four years older than chronological age. The researchers also noted that the gap between brain age and chronological age increased slightly over time in people with diabetes. These associations were attenuated among people with high physical activity who abstained from smoking and heavy alcohol consumption. https://medicalxpress.com/news/2024-08-healthy-lifestyle-counteract-diabetes-brain.html XX   Edgepark Commercial XX Another study showing the link between bright light at night and a higher risk of developing type 2. This study in the journet Lancet In the large modeling study, the research team investigated whether personal light exposure patterns predicted the risk of diabetes using data from approximately 85,000 people and around 13 million hours of light sensor data. The participants – who did not have type 2 diabetes – wore devices on their wrists for one week to track their light levels throughout the day and night. They were then tracked over the following nine years to observe whether they went on to develop type 2 diabetes. “Light exposure at night can disrupt our circadian rhythms, leading to changes in insulin secretion and glucose metabolism,” he says. Having more exposure to light at night (between 12:30 am and 6:00 am) was linked to a higher risk of developing type 2 diabetes, and this was true regardless of how much light people were exposed to during the day. The research accounted for other factors associated with type 2 diabetes, such as lifestyle habits, sleep patterns, shift work, diet, and mental health.   Even after taking these factors into account, the findings showed that getting more light at night was still a strong predictor of developing diabetes. https://scitechdaily.com/scientists-discover-simple-and-cheap-way-to-reduce-your-risk-of-diabetes/ XX Is there a link between voice pitch and glucose levels? And is it strong enough to one day perhaps lead to non-invasive glucose monitronig? Klick Labs published a new study in Scientific Reports today—confirming the link In "Linear Effects of Glucose Levels on Voice Fundamental Frequency in type 2 diabetes and Individuals with Normoglycemia," researchers investigated how blood glucose levels influence the frequency of the voice in 505 participants across three glycemic statuses—non-diabetic, prediabetic, and type-2 diabetic. Participants were fitted with continuous glucose monitors (CGMs) and recorded their voices multiple times daily for two weeks. The analysis revealed a linear relationship where an increase in CGM glucose levels corresponded to an increase in the fundamental frequency in the voice. The lead author says, "Whereas current glucose monitoring methods are often invasive and inconvenient, voice-based glucose monitoring could be as easy as talking into a smartphone, which could change the game for the estimated 463 million people around the world living with type 2 diabetes."   Klick Labs' latest research marks another step forward in its ongoing commitment to advancing the detection and management of diabetes using voice tech and machine learning. Their October 2023 study in Mayo Clinic Proceedings: Digital Health demonstrated that voice and AI can screen for type 2 diabetes with high accuracy.   https://medicalxpress.com/news/2024-08-diabetes-links-blood-glucose-voice.html#google_vignette XX Earlier this year we talked to the teenager behind a free bolus calculator. The FDA took T1D1 down, when they and Apple started cracking down on health tools without regulatory approval. Drew Mendalow has been working to bring it back and we have an update: He says, “Over the last two years, we have been tirelessly working to complete our FDA premarket submission. Thanks to contributions by the T1D community, we were able to complete the preparations needed for the Human Factors Study. The trial itself is the last, vital piece needed before we can submit the app to the FDA. Now, we're thrilled to announce that the team at Dexcom has graciously offered to run the study for us!” It’s a big deal – kudos to Dexcom and to Drew. We’ll let you know when T1D1 is back in the app store. XX Join us again soon!

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A weekly basal plus semaglutide is in the works, but not for the US right now, Tandem updates it's app recall, liver targeted insulin study, a weird walking story, and Lance Bass educates about LADA.  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] 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 Novo Nordisk moves ahead with a new combination: once-weekly insulin icodec and semaglutide. Called IcoSema, Novo plans to submit for approval in Europe, Canada, Japan and Australia but NOT the US. As we told you earlier this summer, icodec – once weeky basal insulin – was not approved by the US FDA. Semaglutide is the molecule underpinning Novo’s immensely popular GLP-1 drugs Ozempic and Wegovy. Icodec has been approved as Awiqli in places like Europe, Canada, Japan and Australia but was snubbed by the FDA last month. The FDA has left the door open for another application, but Novo says they don’t expect to iron it out this year. In studies, the combination worked well to lower A1C for people with type 2 and they lost weight. They also had fewer lows. https://www.fiercepharma.com/pharma/corrected-after-icodec-rejection-novo-nordisk-wont-file-application-once-weekly-insulin-and   XX An update from Tandm on their app recall. Back in March they notified users of the recall because of an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience even after an updated version of the app was released. Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at [email protected] or (877) 801-6901. https://www.businesswire.com/news/home/20240812040222/en/Tandem-Diabetes-Care-Provides-Update-on-March-2024-Nationwide-Recall-of-tconnect-Mobile-App-for-iOS-Devices XX If you are an adult who has type 1 diabetes, you may be eligible to participate in a trial examining the impact of an investigational liver-targeted insulin on blood glucose control, A1C, and nighttime lows. This study is researching whether administering a liver-targeting insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro), will improve glycemic control. HDV-L insulin is designed to act on the liver to enhance glucose storage and decrease the frequency of severe hypoglycemia in individuals requiring insulin. It is not currently approved for use. For this trial, researchers are recruiting roughly 230 adults with type 1 diabetes aged 18-79 who are on multiple daily injections (MDI). This study is recruiting in California, Colorado, Florida, Georgia, Illinois, Indiana, New York, North Carolina, Ohio, and Texas. To enroll or learn more about this study, contact Todd Hobbs, MD at Diasome Pharmaceuticals at [email protected] or call 216-780-9324. Clinical Trials Identifier: NCT06238778 https://diatribe.org/diabetes-research/new-study-tests-liver-targeted-insulin-type-1-diabetes XX Sanofi is investing heavily to boost insulin production. They opened a new facility in Germany for the basal insulin Lantus and they announced they will invest over one billion dollars to expand production capacity in France. Sanofi’s considerable investment in insulin production is especially important given that other insulin companies appear to be focusing their efforts on production of GLP-1 medications like Mounjaro and Ozempic, rather than insulin. This has left some patients worried that Novo Nordisk and Lilly will leave them behind to pursue more lucrative products for weight loss, especially after Novo Nordisk decided to discontinue the basal insulin Levemir. https://diatribe.org/diabetes-medications/sanofi-build-new-state-art-insulin-plant   XX Hoping to talk to Abbott and Medtronic soon about their partnership announced earlier this month. The companies announced that Abbot will create an integrated continuous glucose monitor that works only with Medtronic’s diabetes technology and be sold exclusively by Medtronic. Along with announcing the partnership, Medtronic said Wednesday it received FDA approval for its Simplera CGM, which does not require fingersticks or overtape, unlike the company’s previous sensors. The Simplera Sync sensor, which is designed to work with Medtronic’s automated insulin delivery algorithm, is under FDA review separately. https://www.medtechdive.com/news/abbott-medtronic-partnership-automated-insulin-delivery/723600/ XX Researchers have developed a novel computer algorithm that can predict various diseases like diabetes or stroke, just by analysing the colour of the human tongue with 98 per cent accuracy. The imaging system developed by Middle Technical University (MTU) and the University of South Australia (UniSA) in Australia can diagnose conditions such as diabetes, stroke, anaemia, asthma, liver and gallbladder issues, Covid-19, and other vascular and gastrointestinal diseases. "The colour, shape, and thickness of the tongue can reveal a litany of health conditions," said Ali Al-Naji, adjunct Associate Professor at MTU and UniSA. The paper published in Technologies describes how the system analyses tongue colour to provide real-time diagnoses, demonstrating that AI can advance medical practices significantly. The breakthrough was achieved through a series of experiments using 5,260 images to train machine-learning algorithms to detect tongue colour. Researchers received 60 tongue images from two teaching hospitals in the Middle East, representing patients with diverse health conditions. The AI model matched tongue colour with the correct disease in nearly all cases. https://www.ndtv.com/world-news/new-algorithm-analyses-tongue-to-predict-diabetes-stroke-with-98-accuracy-6327124 XX Big roundup article from the UK Guardian all about 6 projects all around smart insulin. Not a lot new here, but it caused a lot of chatter. I’ll link it up – good summary of all of the research happening in the space right now. Glucose-responsive insulin is the idea that you could give one injection and the insulin would respond to the rise and fall of glucose levels without further action by the person.   https://www.theguardian.com/society/article/2024/aug/11/scientists-hail-smart-insulin-responds-changing-blood-sugar-levels-real-time-diabetes XX Edgepark Commercial XX Lance Bass (like glass) continues to keep the public posted on his recent LADA diagnosis. The boy band singer showing his IG audience more about what’s also called diabetes 1.5 and explaining how he was first diagnosed with type 2. XX Ok, brace yourself – I promise this is a real story. The Fart Walk is actually good for you. Ok.. stay with me. This is really just a great silly reframing of something we all know, and I couldn’t resist putting it in here. A wellness influencer put this out – you may have seen it – claiming the after dinner stroll can limit your risk of type 2 diabetes. A lot of studies confirm that – along with it having benefits if you already have diabetes. The flatulence part – or a release of gastric pressure – is also a known benefit of moving more after meals. So it’s funny, farts are always funny, but if it gets more people to walk after they eat I’m all for it.   https://people.com/fart-walk-benefits-what-is-it-type-2-diabetes-8694630#:~:text=Wellness%20influencer%20Mairlyn%20Smith%20has,of%20day%20you%20do%20it XX Join us again soon!

Talking about any possible complications from diabetes can be scary – and most of us only think of kidney issues in the worst possible way: transplant and dialysis. But there’s a lot you can do to stay healthy and there’s news from just this summer about how new medications are making a big difference to reduce your risk. My guests this week are Dr. Bob Gabbay, Chief Scientific and Medical Officer, American Diabetes Association and Dr. Jeff Giullian, Chief Medical Officer of DaVita. DaVita Kidney Care is a leading provider of kidney care in the United States. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More information about Kidney health here Find out more about Moms' Night Out - registration is open for Denver and Philadelphia! Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected]

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