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Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss a series of major pediatric diabetes advancements announced around the American Diabetes Association (ADA) Scientific Sessions 2026, highlighting how recent regulatory decisions are expanding treatment options and improving access to diabetes technologies.The conversation opens with the expanded FDA indication for teplizumab in children and adolescents with newly diagnosed stage 3 type 1 diabetes. Bellini reviews findings from the PROTECT trial, which evaluated teplizumab in patients ages 8 to 17 years within six weeks of diagnosis. She explains that treatment with two 12-day infusion courses resulted in significant preservation of endogenous insulin production, with 95% of participants maintaining peak C-peptide levels above the study threshold at week 78. The hosts discuss the importance of preserving residual beta-cell function, emphasizing its potential role in improving glycemic stability, reducing hypoglycemia risk, and supporting better long-term outcomes for individuals who will live with type 1 diabetes for decades.Isaacs and Bellini explore how this new indication may change the approach to type 1 diabetes screening, particularly among first-degree relatives and individuals at higher risk for autoimmune disease. They note that identifying people in stage 2 type 1 diabetes remains challenging because patients are typically asymptomatic, but the availability of treatment at stage 3 provides clinicians with a new opportunity to intervene soon after diagnosis.The hosts discuss how having an approved therapy may encourage more families to pursue screening and identify additional individuals with early-stage disease. They also address practical considerations, including the importance of starting treatment within the appropriate window, coordinating the two infusion courses, supporting families through treatment logistics, and ensuring access through insurance coverage.The discussion then shifts to the FDA clearance of Dexcom Stelo, the first over-the-counter glucose biosensor cleared for pediatric use in children ages 2 years and older who do not use insulin. Isaacs highlights how this technology could improve access to glucose monitoring for children with prediabetes, type 2 diabetes, or those seeking greater insight into how food, activity, and lifestyle factors influence glucose patterns.The hosts emphasize that expanded access to glucose monitoring could play an important role in helping families make informed decisions about diabetes management. However, they clarify that individuals using insulin require prescription continuous glucose monitoring systems with additional safety features, including hypoglycemia alerts and predictive low glucose notifications.Finally, Isaacs and Bellini discuss the pediatric approval of inhaled insulin as another significant milestone in diabetes care. They review its potential as an alternative to mealtime injections and highlight the opportunity to provide more flexibility for children and families managing type 1 diabetes. The conversation also addresses implementation considerations, including baseline lung function testing, provider familiarity, and adapting clinical workflows to incorporate new treatment approaches.The episode concludes by reflecting on the rapid progress occurring in pediatric diabetes care. With advances in immune-modulating therapies, glucose monitoring technology, and insulin delivery options, the hosts highlight a new era of personalized diabetes management focused on preserving insulin function, improving access, and optimizing outcomes for young people living with diabetes.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Sanofi. Press Release: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes. June 12, 2026. Accessed June 18, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-12-22-09-58-33113492: US Food and Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children. June 12, 2026. Accessed June 18, 2026. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children3: Livingston R. FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes. HCPLive. May 29, 2026. Accessed June 18, 2026. https://www.hcplive.com/view/fda-approves-inhaled-insulin-afrezza-pediatric-patients-diabetes

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, shot live at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the latest major trial results like CONNECT, TRIUMPH, and TRANSCEND.To begin the episode, Isaacs and Bellini, discuss major highlights from ADA Scientific Sessions, focusing first on the landmark CONNECT trial evaluating continuous glucose monitoring (CGM) in people with type 2 diabetes who are not treated with insulin. They reflect on the evolution of CGM technology, from its early use primarily in type 1 diabetes to its expanding role in type 2 diabetes management, and explain why this trial represents an important step forward for patients who have historically had limited access to CGM.The hosts review the randomized controlled trial findings, emphasizing the significant improvements in glycemic outcomes, including a 1.6% reduction in A1c from baseline and an approximately 0.9% greater reduction compared with standard care. They also highlight the increase in time in range, with participants using CGM achieving roughly five additional hours per day in target glucose range. The magnitude of these findings is discussed as a practice-changing development, with the potential to influence future clinical guidelines and strengthen recommendations for CGM use among individuals with type 2 diabetes who are not using insulin.The discussion also explores the broader implications of the CONNECT trial for healthcare access and insurance coverage. The hosts note that randomized controlled trial evidence has historically played a key role in shaping standards of care and payer decisions, and they suggest that these results may help support wider adoption of CGM by demonstrating meaningful improvements in glucose control and patient outcomes.The conversation then shifts to emerging pharmacologic advances, with a focus on retatrutide, a novel triple agonist targeting GLP-1, GIP, and glucagon pathways. The hosts discuss new data showing substantial metabolic benefits in people with type 2 diabetes, including up to 17% weight reduction and nearly 2% A1c lowering. They highlight how these findings represent a major advancement in diabetes and obesity treatment, particularly as clinicians continue to see increasingly powerful effects from next-generation incretin-based therapies.Isaacs and Bellini explore how these therapies may reshape treatment strategies by allowing clinicians to tailor medication choices based on individual patient needs and goals. They discuss the importance of considering both glucose lowering and weight reduction effects, recognizing that some patients may benefit from significant weight loss while others may require a more balanced approach focused primarily on glycemic improvement.The hosts also address important unanswered questions surrounding the use of highly effective weight-loss medications, including appropriate treatment targets, the limitations of BMI as a measure, and the importance of preserving muscle mass and overall function. They emphasize the need to consider body composition, physical activity, resistance training, and patient characteristics—particularly in older adults or those at risk for frailty—when developing long-term treatment plans.The episode concludes with a reflection on the rapidly evolving landscape of diabetes care. The hosts highlight how advances in CGM technology and novel metabolic therapies are creating new opportunities to improve outcomes, personalize treatment approaches, and redefine the future management of people living with diabetes.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this special episode, shot live at the American Diabetes Association (ADA) Scientific Sessions 2026 in Ner Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Amit Gupta, MBBS, DNB, diabetologist, executive director of the Global Metabolic Health Alliance, and chair of the International Diabetes Federation (IDF) Education Committee, to discuss the state of diabetes care and treatment in India compared to the US.To begin the episode, Gupta introduces the mission of the IDF, highlighting its role as a worldwide federation of scientific societies and patient organizations focused on improving diabetes education, policy, advocacy, and access to care. The conversation explores how diabetes management differs across regions, emphasizing that while the underlying disease mechanisms and available therapies may be similar, access to medications, technologies, healthcare infrastructure, and education varies significantly between countries.Gupta discusses the impact of semaglutide becoming available as a generic therapy in India following patent expiration, describing how reduced costs have improved access to a medication previously limited by affordability barriers. The group considers how increased availability of GLP-1 receptor agonists may transform diabetes and obesity management, while also emphasizing that pharmacologic therapies alone cannot address the global metabolic health crisis. Gupta notes the importance of maintaining focus on long-term lifestyle changes, including nutrition, physical activity, and sustainable weight management, as essential components of comprehensive care.The discussion then shifts to diabetes education and the need for more individualized, patient-centered approaches. Gupta highlights that education must be adapted to regional and cultural contexts, explaining that the challenges faced by a person with diabetes in the United States, Africa, India, or other parts of the world may differ substantially, even though diabetes distress and the burden of daily decision-making are shared experiences. He emphasizes that access to technology, such as continuous glucose monitoring, does not eliminate the need for education and support.Isaacs, Bellini, and Gupta also address the growing challenge of misinformation online and the role of healthcare professionals in helping patients navigate unreliable sources of health information. Gupta explains that clinicians must approach misinformation constructively by providing evidence-based guidance rather than simply dismissing patients' beliefs, reinforcing the importance of translating scientific evidence into practical recommendations that patients can incorporate into their daily lives.The group further examines disparities in the availability of diabetes educators worldwide. Gupta notes that while some regions have established professional pathways for diabetes care and education specialists, many areas lack standardized training, recognition, or policy support to sustain these roles. He stresses that building effective diabetes education systems requires collaboration with policymakers to demonstrate the long-term benefits of structured education programs.The episode concludes with Gupta discussing his work developing a global consensus framework on lifestyle as the foundation of metabolic health. The conversation reinforces that advances in medications and technology must be paired with equitable access, effective education, and sustainable lifestyle interventions to reduce the global burden of diabetes and improve outcomes for people living with metabolic conditions.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. Gupta reports disclosures with Lilly, Abbott Diabetes, and the International Diabetes Federation.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this special episode recorded live at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Trang Ly, PhD, MBBS, senior vice president and Chief Medical Officer at Insulet, to discuss the continued evolution of automated insulin delivery (AID) technology and emerging developments across the Omnipod platform. To begin the episode, Ly first reviews updates to Omnipod 5, focusing on enhancements aimed at increasing time in automated mode and improving glucose management. She explains that user feedback identified opportunities to support lower glucose targets and reduce interruptions related to system alerts. Data from real-world evidence and computer simulations suggest that lowering the glucose target from 110 to 100 mg/dL may lead to meaningful improvements in time in range and time in tight range without increasing hypoglycemia risk.The group discusses early clinical experience with these enhancements, including findings from users who transitioned to the updated system. Ly highlights that even a highly engaged population already using lower targets experienced additional improvements, including a 2% increase in time in range and a 5% increase in time in tight range over a short period of use. The conversation emphasizes the importance of making these improvements broadly available rather than waiting for routine follow-up visits, particularly given the potential benefits without additional safety concerns.The discussion then turns to Omnipod 6, with Ly sharing newly presented clinical trial data evaluating the next-generation system. She describes the study design, which enrolled users already achieving strong glycemic control on Omnipod 5 and assessed whether further intensification through algorithm improvements could safely provide additional benefits. The results demonstrated a 4% improvement in time in range and up to a 7% increase in time in tight range, with particularly notable improvements among individuals with type 1 diabetes aged 14 years and older.Ly explains that Omnipod 6 builds on previous technology through changes to the core algorithm, allowing the system to deliver more insulin when users do not bolus consistently. The panel explores how this approach may reduce the burden of diabetes management by allowing the algorithm to take on more responsibility while maintaining glycemic control. They discuss the potential psychological benefits of reducing the daily demands placed on people with diabetes, especially as sensor accuracy and automation continue to improve.The conversation also highlights future opportunities for AID in type 2 diabetes. Ly shares early feasibility data from a fully closed-loop system designed specifically for individuals with type 2 diabetes, emphasizing its simplified approach without requiring traditional pump programming or meal bolusing. In this study, participants experienced improvements in time in range, demonstrating the potential for automated insulin delivery to reach broader populations.Isaacs and Bellini discuss the need to reconsider barriers to insulin pump adoption in type 2 diabetes and recognize AID as an accessible option for patients who may benefit. Ly emphasizes that technology should support people across different levels of engagement, offering both highly customizable systems for those seeking intensive management and simpler automated approaches for those looking to reduce daily treatment demands.The episode concludes with a discussion of the future of diabetes technology, including improved connectivity, expanded device flexibility, and continued integration with complementary therapies such as GLP-1 receptor agonists. Ly underscores that innovation should not only improve clinical outcomes but also reduce the burden of care, allowing people with diabetes to spend less time managing their condition and more time living their lives.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. Ly reports a disclosure with Insulet.References1: Insulet. Insulet Reveals New Data Supporting Breakthrough Omnipod 6 and Fully Closed-Loop AID Systems Designed to Improve Outcomes, Reduce Effort, and Unlock Barriers to Care. June 6, 2026. Accessed June 7, 2026. https://investors.insulet.com/news/news-details/2026/Insulet-Reveals-New-Data-Supporting-Breakthrough-Omnipod-6-and-Fully-Closed-Loop-AID-Systems-Designed-to-Improve-Outcomes-Reduce-Effort-and-Unlock-Barriers-to-Care/default.aspx

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this special episode recorded live at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Ketan Dhatariya, MD, PhD, MS, consultant physician at Norfolk and Norwich University Hospitals, to discuss the evolving landscape of diabetes care, technology access, and clinical implementation. To begin the episode, Dhatariya shares his perspective on the challenges facing diabetologists, including workforce pressures, specialist training, and the difficulty of translating rapidly expanding diabetes guidelines and innovations into everyday clinical practice. The conversation then shifts to the differences between healthcare systems and how those structures influence access to diabetes therapies. Dhatariya discusses the UK's publicly funded healthcare model and the ongoing challenge of balancing the cost of emerging medications and technologies with their long-term benefits. He highlights the importance of demonstrating that investments in diabetes care today can reduce complications and healthcare costs in the future.Dhatariya then reviews the progress of continuous glucose monitoring (CGM) and automated insulin delivery (AID) adoption in the UK. He explains that CGM use among people with type 1 diabetes has become widespread, particularly among children, and that access to closed-loop systems continues to expand through structured implementation plans. He emphasizes the meaningful improvements these technologies have provided, including better glycemic outcomes among children and pregnant individuals, who may experience significant benefits from improved glucose management.The discussion explores how diabetes technology can support people with different lifestyles and challenges, while challenging assumptions about which patients may benefit most from advanced therapies. Dhatariya highlights that CGM and AID can provide valuable support for individuals who may struggle with traditional insulin management, while also emphasizing the need for appropriate education and follow-up to ensure safe and effective use.The group also discusses CGM use in type 2 diabetes and the growing evidence supporting broader access. Dhatariya explains that adoption has been slower because of the larger population affected by type 2 diabetes but notes emerging data suggesting CGM may help reduce complications, hospitalizations, and long-term healthcare costs. He describes the impact of seeing real-time glucose data, explaining how personal experience with CGM can help people better understand the relationship between food, behavior, and glucose patterns.The conversation then turns to access to GLP-1 receptor agonists in the UK and how healthcare systems determine eligibility for newer therapies. Dhatariya discusses the role of national guidance and health economic evaluations in balancing access, affordability, and sustainability. He highlights how improving obesity-related disease management may have broader benefits, including helping reduce the burden of diabetes, cardiovascular disease, and other chronic conditions.The episode also explores inpatient diabetes care and the increasing presence of diabetes technology in hospital settings. Dhatariya discusses guidance developed by the Joint British Diabetes Societies for Inpatient Care to help clinicians safely manage patients admitted while using CGM, insulin pumps, and AID systems. He emphasizes that devices should not automatically be removed and that patients may be able to continue using technology when they are well enough and capable of managing their systems.Finally, Dhatariya discusses the importance of structured diabetes education, including the DAFNE (Dose Adjustment For Normal Eating) program, which teaches carbohydrate counting, insulin adjustment, and self-management skills. He emphasizes that as diabetes technology becomes more advanced, education remains essential for both patients and clinicians. The episode concludes with a discussion of the need for continued advocacy, specialist care, and equitable access to ensure people with diabetes can benefit from ongoing advances in diabetes technology.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. Dhatariya reports disclosures with AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this special episode recorded on-site at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Dr. Eugene Wright Jr., MD, the principal of Wright Health Care Solutions and a consulting associate in the department of medicine at Duke University Medical Center, to discuss the development of the ADA scientific statement on diabetes technology implementation in primary care. To begin the episode, Wright reflects on his career as an internist caring for patients with diabetes across diverse settings, including underserved communities where patients often faced significant barriers to accessing care. He describes how his experiences challenged assumptions about which patients would benefit from diabetes technology, noting that many under-resourced patients demonstrated strong engagement and improved self-management when given access to tools such as continuous glucose monitoring (CGM).The discussion focuses on the origins of the ADA scientific statement, which emerged from efforts to identify and overcome barriers limiting the adoption of diabetes technology in primary care. Wright explains that while diabetes technology has demonstrated significant benefits in improving outcomes and patient behaviors, implementation has remained slow in the settings where most people with diabetes receive care. The statement brought together key stakeholders, including clinicians, pharmacists, diabetes care and education specialists, patient representatives, and other experts, to develop practical strategies addressing policy, insurance, workflow, and clinical challenges.Isaacs, Bellini, and Wright explore how CGM can be successfully integrated into primary care by shifting the focus from simply providing access to using data effectively. Wright emphasizes that CGM and ambulatory glucose profile (AGP) reports allow clinicians to transform complex glucose data into actionable insights, helping identify patterns that may not be captured through A1C measurements or traditional glucose monitoring. The group discusses how CGM enables clinicians to ask better questions, uncover barriers to treatment, and engage patients in collaborative conversations without judgment.The hosts highlight the importance of building sustainable workflows, including preparing AGP reports before visits, assigning responsibilities across the care team, and identifying technology champions within practices. Wright explains that successful implementation requires recognizing the unique needs and resources of each primary care setting rather than applying a single model. They discuss the role of telehealth, clinical pharmacists, medical assistants, and other team members in supporting CGM initiation, interpretation, and ongoing management. The conversation also addresses how partnerships with technology manufacturers can simplify onboarding, training, troubleshooting, and patient support.The discussion then expands to insulin pumps and automated insulin delivery systems, with the group noting how advances in technology have reduced complexity and made these therapies more accessible for people with type 2 diabetes. Wright describes how newer systems can help reduce the daily burden of diabetes management by automating adjustments and supporting patients in achieving their goals. The hosts emphasize that diabetes care should move beyond focusing only on glucose metrics and instead consider the lived experience of patients, including the constant decision-making and emotional burden associated with managing diabetes.The episode concludes with a broader call to action for expanding access to diabetes technology across all healthcare settings. Wright emphasizes that many patients do not have access to endocrinology care but still deserve the benefits of modern diabetes tools. The scientific statement represents the beginning of an ongoing effort to improve implementation, strengthen collaboration among stakeholders, and ensure that diabetes technology reaches all patients who can benefit from it.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. Wright Jr. reports disclosures with Abbott Diabetes, Bayer AG, Boehringer Ingelheim, Lilly, and Sanofi.ReferencesSection 7: Diabetes technology. Diabetes Obesity and Cardiometabolic CARE. Published online March 23, 2026. doi:10.2337/doc26-a007

It's in the News! The top diabetes stories and headlines happening now. Top stories this week include: Afrezza inhaled Insulin is Approved for Kids, CGM + Ketone Monitor gets European approval, Food Coloring & Diabetes Study, Device Recalls include Omnipod and Dexcom, Beta Bionics shares more about their patch pump, ADA conference info and more! This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about 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 Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Episode transcripts: Welcome! I'm your host Stacey Simms and this is an In The News episode.. where we bring you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes. ADA starts this week – safe travels to those of you heading to New Orleans. We'll be covering remotely so please follow on social – make sure to Like the FB page or join the group. We've got a wrap up episode planned for this podcast as well as some indepth interviews with the newsmakers from the conference. I will see some of you next week in Chicago. We have a couple of seats left for our Club 1921 dinner on June 10th in Northbrook – this is a FREE dinner for HCPs and patient leaders – all about screening for T1D. More info on the website under the events tab. Okay.. our top story this week: XX Afrezza inhaled insulin is now approved for kids and teens. The FDA okayed MannKind's afrezza for children 6 and older with type 1 and type 2 diabetes. MannKind says its proprietary Technosphere drug delivery platform enables the rapid absorption of insulin into systemic circulation. This follows FDA approval earlier this year for an update that revises recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. MannKind also completed enrollment in February for a study evaluating the initiation of Afrezza therapy shortly after type 1 diabetes diagnosis in pediatric patients.   The company said it made Afrezza available for eligible patients for $35 or less per month. Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine, said: "Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary. With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option." Lots more to come on this – we're working on a bonus episode with one of the pediatric endos who worked on the clinical trials that led to this approval – hopefully have that out later this week. https://www.massdevice.com/mannkind-fda-approval-inhaled-insulin-children/ XX FDA has agreed to consider a new drug for the treatment of adults with type 1 and chronic kidney disease. Finerenone (fy-near-uh-known) is currently approved in the US for adults with CKD associated with type 2 diabetes and for adults with heart failure with left ventricular ejection fraction of 40% or greater. Chronic kidney disease (CKD) is present in over one-third of adults with diabetes, and because it's such a serious condition, interventions are needed to reduce its incidence and help people live a long and prosperous life. https://www.docwirenews.com/post/fda-grants-priority-review-to-finerenone-snda-for-type-1-diabetes-associated-ckd XX Abbot gets European approval for the world's first dual glucose‑ketone sensing technology for people with diabetes. They're calling this Libre Duo and Libre Duo 10 Day, and it's designed to continuously measure glucose and ketone levels every minute. Abbott plans to begin launching Libre Duo systems in select European countries later this year. Libre Duo delivers up to 15 days of wear and will be offered to adults ages 18 and older. Libre Duo 10 Day offers up to 10 days of wear and is intended for people ages 2 and older. Abbott is also working with leading pump companies to allow automated insulin delivery (AID) systems to connect with the sensors. https://abbott.mediaroom.com/2026-05-27-Abbott-secures-CE-Mark-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes   XX Huge recall for Omnipod. Insulin says a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery  with specific lots of its Omnipod 5, Dash and Eros pods. Insulet said the scope of this action reaches approximately 7 million pods. This issue is separate from the March recall that affected certain Omnipod 5 lots. According to the Acton, Massachusetts-based company, some of its affected pods may have a small tear in the tubing (cannula) just above the skin. This tear lands between the pod and the point where the cannula enters the body. If this occurs, insulin may leak outside of the device instead of being fully delivered into the body as intended. This may lead to under-delivery of the therapeutic.   Individuals using an affected pod may notice wetness on the skin or pod adhesive or detect the smell of insulin. However, some cases may prove difficult to detect and go unnoticed. Of the approximately 7 million pods included in the action, approximately 60% have been consumed or are expired. The pods affected by the correction represent approximately 8.5% of the 2025 global Omnipod pod prodcution. Insulet says it has sufficient supply to replace affected pods. It expects no disruption to product availability. The company said it has notified the FDA and all other relevant regulatory authorities of its action.   The full list of affected pod lots can be found here. https://www.massdevice.com/insulet-another-omnipod-5-recall-dash-eros/ XX Dexcom is warning that certain scrapped glucose sensors have been stolen and resold. Dexcom said it has not received any reports of severe adverse events associated with the stolen product. One lot of scrapped devices carries a risk of infection for sensors that are not properly sterilized, and another lot had an elevated internal testing failure rate, meaning users would have an increased risk of having no sensor readings available. Dexcom said the affected sensors were stolen during the destruction process and then sold by third parties. The company routinely scraps sensors that do not meet its standards. The sensors are sent to a third-party vendor for destruction and recycling.   Dexcom said it traced sales of the stolen devices to Pharmsource, which is not an authorized Dexcom distributor but supplies some independent pharmacies and U.S. durable medical equipment distributors. Because of this, pharmacies that purchase products from Pharmsource should review their inventory, Dexcom said.   People with sensors from the affected lots should not use those sensors and can call customer support to request replacements. Dexcom has set up a website to help users check if their devices are affected. https://www.medtechdive.com/news/dexcom-warns-of-scrapped-glucose-sensors-being-resold/821139/ XX XX   Beta Bionics plans to debut its first insulin patch pump by the end of the second quarter of 2027, subject to Food and Drug Administration clearance. The device, called Mint, would be compatible with Beta Bionics' interoperable automated glycemic controller, a software that allows for the pump to automatically adjust insulin delivery based on readings from a glucose sensor. Beta Bionics first unveiled the prototype for Mint last year at the American Diabetes Association's Scientific Sessions. The device is expected to have a similar size and wear time, at three days, to Insulet's patch pumps on the market. It would have a 200-unit insulin reservoir.   Mint differs by containing a mix of reusable and disposable components. Beta Bionics plans to make the device exclusively available in the pharmacy channel, building on its existing agreements for its current iLet insulin pump. Beta Bionics is one of several diabetes tech companies developing patch pumps to compete with market leader Insulet. Tandem Diabetes Care and Medtronic spinoff MiniMed have also announced planned patch pumps. Tandem said it plans to file a 510(k) submission this quarter for a tubeless version of its small, durable pump, and Medtronic plans to submit its patch pump to the FDA this fall.   https://www.medtechdive.com/news/beta-bionics-to-launch-its-first-insulin-patch-pump-to-compete-with-insulet/821091/ XX CVS puts Zepbound back on it's coverage list – with it's Caremark PBM. They also added Foundayo, Lilly's obesity pill. CVS had dropped Lilly's Zepound last summer but kept competitor Wegovy. It'll be back at Caremark October first. All three of the nation's largest pharmacy ⁠benefit managers ​now cover Lilly's full obesity medicine portfolio. https://www.reuters.com/legal/litigation/cvs-brings-back-coverage-lillys-obesity-drug-zepbound-2026-05-28/   More to come, including a new benefit from metformin for women, something new from Tidepool, big news for T1D in Austalia and more.. XX A new study suggests that higher long-term exposure to food colouring additives — including both synthetic and natural colourings commonly found in processed foods and beverages — may be associated with an increased risk of developing type 2 diabetes. Researchers analyzed data from more than 108,000 adults in the French NutriNet-Santé cohort between 2009 and 2023, following participants for a median of just over eight years. During that time, 1,131 participants developed type 2 diabetes. The study found that people with the highest intake of total food colouring additives had a 38% higher risk of developing type 2 diabetes compared with non- or low-consumers.   Several specific additives were linked to increased risk, including caramel colouring additives such as total caramel (E150 family), plain caramel (E150a), sulphite ammonia caramel (E150d), and beta-carotene (E160a). Additional associations were observed for curcumin (E100), anthocyanins (E163), paprika extract (E160c), lutein (E161b), and cochineal-derived colourings (E120). "Our findings revealed positive associations between widely consumed food colouring additives and type 2 diabetes incidence," the authors wrote, adding that further research is needed to better understand the mechanisms behind the findings and whether food colouring regulations should be reevaluated. https://www.medscape.com/viewarticle/use-common-food-colours-tied-high-type-2-diabetes-risk-2026a1000hes XX Big news for Australia – their Therapeutic Goods Administration (TGA) approves Tzield. Tzield is now approved in Australia to delay the onset of stage 3 (or clinical) T1D in people aged eight years and older with stage 2 T1D – the early, pre-symptomatic stage of the condition, where changes in blood glucose levels have begun but insulin therapy is not yet required. Breakthrough T1D Australia Chief Executive Officer, Sydney Yovic, said the approval represented a transformational moment for Australians affected by T1D. https://newshub.medianet.com.au/2026/05/landmark-approval-of-tzield-in-australia-ushers-in-a-new-era-of-delay-for-type-1-diabetes/155036/ XX https://www.theatlantic.com/health/2026/05/diabetes-pregnancy/687324/ XX A common diabetes drug may hold great potential to help with aging, even if scientists aren't exactly sure why. According to a study, the drug metformin doesn't just help patients to effectively manage their type 2 diabetes. it may also give older women a better chance of living to 90. Scientists in the US and Germany used data from a long-term US study of postmenopausal women.   Records for a total of 438 people were selected – half of whom took metformin to treat diabetes, and half of whom took a different diabetes drug, sulfonylurea.   While there are some caveats and asterisks to the study, those in the metformin group were calculated to have a 30 percent lower risk of dying before the age of 90 than those in the sulfonylurea group. The study used age 90 as the marker for 'exceptional' longevity. However, scientists aren't yet sure that the drug extends lifespan, especially in humans – which is part of the reason for this study. RCTs could follow further down the line to dig deeper into these results, the researchers suggest. In the meantime, as the global population continues to skew older, studies continue to find ways to keep us healthier for longer and reduce damage to the body as we age. https://www.sciencealert.com/a-common-diabetes-drug-is-linked-with-exceptional-longevity-in-women XX The American Diabetes Association® (ADA) will host the 2026 Scientific Sessions from June 5-8 in New Orleans. The ADA's Scientific Sessions is the world's largest diabetes meeting, convening an expected audience of over 12,000 leading physicians, scientists, researchers, and healthcare professionals from around the globe. The premier diabetes meeting, which is also offered virtually, will feature the latest scientific findings in diabetes and obesity, where leading experts and peers will share findings in research for prevention, care, and cures at the Ernest N. Morial Convention Center. Key themes will include: Advancing obesity and metabolic health: Prevention, early detection, and disease modification: Improving cardiometabolic outcomes: Transforming care through innovation and access: New research will highlight how technology, artificial intelligence, and implementation strategies are reshaping diabetes care—reducing treatment burden, expanding access, and enabling more person-centered care. Advancing beta cell replacement and cure strategies: Fostering innovation: On Saturday, June 6, from 4:30-6:00 p.m., the Innovation Challenge, which debuted in 2023, invites emerging companies to pitch novel ideas to improve the lives of people living with diabetes. A panel of judges, with input from a live audience, determines which contestants will earn a private audience with potential funders. XX Tidepool, the nonprofit leader advancing innovation in diabetes technology, announced that Tidepool+ Direct Connect is now available through the Epic Showroom. Built on SMART on FHIR, Direct Connect brings interactive diabetes device data directly into Epic workflows, helping clinicians use patient data during routine care. "Tidepool has always focused on making diabetes data more accessible and actionable," said Brandon Arbiter, CEO. "We're excited to empower clinicians using Epic with insightful, intuitive patient data that fits directly into their encounter workflow so they can use it to improve care in the moment it matters."   Tidepool+ Direct Connect supports scalable deployment across Epic-enabled health systems. This architecture enables faster, more intuitive rollouts, enhancing Tidepool's existing EHR integration capabilities.   Direct Connect is part of Tidepool's ongoing work to improve how clinicians can use timely and relevant diabetes device data during patient visits to help drive better health outcomes.   The feature is now available in the Connection Hub of the Epic Showroom.   https://www.businesswire.com/news/home/20260527780274/en/Tidepool-Launches-in-Epic-Showroom-to-Bring-Diabetes-Device-Data-into-the-Point-of-Care XX

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a range of fascinating advancements in the industry, each with significant implications for future patient care and drug development. At the recent American Society of Clinical Oncology (ASCO) 2026 conference, Akeso's ivonescimab, a pioneering PD-1xVEGF bispecific antibody, demonstrated a 34% reduction in death risk when combined with chemotherapy for first-line lung cancer treatment. This marks a pivotal moment in cancer therapeutics, illustrating how bispecific antibodies can enhance treatment efficacy. The evolving landscape of cancer treatment continues to highlight the importance of these innovative approaches. Johnson & Johnson's Erleada has shown promising results in prostate cancer, achieving positive outcomes in its Phase 3 Proteus study. The trial emphasized the efficacy of Erleada when administered perioperatively to prostate cancer patients, indicating a shift towards more personalized and comprehensive care that incorporates targeted therapies before and after surgery. In another significant breakthrough, Lilly's Retemvo exhibited dramatic results in early-stage lung cancer with RET fusion-positive markers, reducing disease progression or death by 83% as adjuvant therapy. This underscores the critical role of molecularly targeted therapies for patients with specific genetic profiles, offering hope for improved survival outcomes. On the frontlines of infectious diseases, Shionogi's COVID-19 antiviral Xocova has received FDA approval as a post-exposure prophylactic. This milestone highlights the challenging yet dynamic landscape of antiviral drug development, offering a new tool in managing COVID-19 exposures after previous challenges in demonstrating effectiveness as a treatment. MannKind's inhaled insulin, Afrezza, has been approved for pediatric use. This approval could rejuvenate its market presence by providing a more convenient insulin delivery system aimed at improving adherence and glycemic control among younger patients. In oncology news, Pfizer's Talzenna combination therapy received broader FDA approval for castration-sensitive prostate cancer. This positions it as a competitive option against Johnson & Johnson's PARP inhibitor combination therapy. Additionally, AstraZeneca's Imfinzi and Imjudo combination showed promise in early-stage liver cancer by reducing disease progression risks by 30%, broadening immunotherapy applications. The market dynamics are also shifting with significant strategic movements like Eli Lilly's acquisition of Kelonia Therapeutics for $3.2 billion. This decision is driven by promising in vivo CAR-T data demonstrating unprecedented response rates and reflects the increasing importance of innovative CAR-T therapies in oncology. Eli Lilly's Kelonia Therapeutics' cell therapy showcased an impressive 100% response rate in a Phase 1 trial for relapsed or refractory multiple myeloma. This CAR-T therapy targets the BCMA antigen and could revolutionize treatment paradigms by offering more effective responses. Meanwhile, Pfizer's transformative research on RAS inhibitors holds potential to redefine treatment paradigms in pancreatic cancer—a notoriously difficult-to-treat type due to its complex biology. Revolution Medicines aims to maintain its leadership within this space amidst growing competition. Revolution Medicines also reported compelling results with their KRAS inhibitor, which nearly doubles survival rates for metastatic pancreatic cancer patients harboring KRAS mutations. Given the historically poor prognosis associated with pancreatic cancer, these findings represent a significant advancement in managing this aggressive type. In ovarian cancer research, Gilead's TUB-040 demonstrated a 61% tumor response rate for platinum-resistant ovarian cancer in a Phase 1 trial. This highlights the potential of antibody-drug conjugates (ADCs) to overcome resistance mechanisms and improve outcomes in difficult-to-treat cancers. Regulatory updates include Johnson & Johnson receiving FDA label expansion for Tremfya to inhibit structural joint damage in active psoriatic arthritis patients. This expansion provides broader treatment options for patients suffering from debilitating conditions by reinforcing the role of IL-23 inhibitors in autoimmune disease management. Strategic partnerships are also shaping drug development's future landscape. Notably, Servier's acquisition of Edgewise Therapeutics' muscular dystrophy unit underscores growing focus on rare diseases and neuromuscular disorders. Eli Lilly's agreements with Haisco Pharmaceutical and Hanmi Pharm reflect ongoing R&D investments aimed at expanding therapeutic portfolios across various indications. These developments illustrate a broader trend toward personalized medicine and targeted therapies that enhance treatment efficacy by leveraging specific genetic or molecular characteristics. Despite advancements, challenges remain as exemplified by Oculis' OCS-01 failing Phase 3 trials for diabetic macular edema—highlighting inherent risks in drug development. Overall, these updates underscore significant scientific progress and promise improvements in patient outcomes through novel therapeutic approaches and collaborative efforts within this vibrant industry landscape.Support the show

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the recent FDA approval of MannKind's inhaled insulin Afrezza for pediatric patients aged 6 years and older with both type 1 and type 2 diabetes, describing the decision as a major milestone in diabetes therapeutics and the first expansion of the therapy beyond adults. The episode centers on the clinical implications of the approval, the pharmacologic advantages of inhaled insulin, and the practical considerations surrounding implementation in pediatric care settings.The hosts review findings from the INHALE-1 trial, which enrolled 230 pediatric participants aged 4 to 17 years and compared inhaled insulin used alongside basal insulin with standard multiple daily injection (MDI) therapy over 56 weeks. Bellini emphasizes that the study achieved its primary objective of demonstrating glycemic outcomes comparable to traditional insulin regimens, noting that insulin studies are generally designed to establish equivalence rather than superiority. Beyond similar glycemic control, the hosts highlight several clinically meaningful secondary observations, including stable BMI among participants receiving inhaled insulin compared with weight gain in the MDI cohort, increased treatment satisfaction reported by both adolescents and parents of younger children, comparable hypoglycemia rates, and the absence of new safety concerns. Bellini also notes that no decline in lung function was observed among participants using inhaled insulin, despite historical concerns surrounding pulmonary safety with inhaled therapies.A major focus of the discussion is the physiologic pharmacokinetic profile of Afrezza, which Isaacs characterizes as the most physiologic insulin currently available. She explains that inhaled insulin demonstrates measurable activity within approximately 12 minutes, peaks within 35 to 45 minutes, and clears the bloodstream in roughly 90 minutes. The hosts contrast this with subcutaneous rapid-acting insulin analogs, including ultra-rapid formulations, which retain a prolonged “tail” of insulin activity that can increase hypoglycemia risk. Isaacs and Bellini suggest that the shorter duration of inhaled insulin may reduce the cycle of overtreating hypoglycemia and subsequent rebound hyperglycemia, thereby potentially contributing to the absence of weight gain observed in the trial. Bellini further emphasizes that the rapid onset and offset of inhaled insulin restore some of the flexibility and spontaneity often lost in intensive insulin therapy, particularly around meal dosing and correction strategies.The conversation also situates inhaled insulin within the broader framework of individualized diabetes management and the ADA Standards of Care. Isaacs stresses that the approval should not be viewed as competing with automated insulin delivery (AID) systems, but rather as expanding patient choice. The hosts discuss how inhaled insulin may be especially valuable for individuals who do not wish to wear insulin pumps, desire periodic breaks from technology, or want to reduce the burden of injections. Isaacs additionally highlights the growing prevalence of pediatric type 2 diabetes and notes that, despite advances in incretin-based therapies, many youth still require insulin therapy. In that context, the possibility of pairing inhaled mealtime insulin with emerging once-weekly basal insulin formulations and GLP-1 receptor agonists is presented as a potentially transformative strategy for minimizing injection burden.Bellini and Isaacs also address practical implementation challenges within school settings. Because inhaled insulin acts rapidly, Bellini notes that administration timing may need to shift from the nurse's office to the cafeteria environment to avoid hypoglycemia if meals are delayed. At the same time, both hosts recognize that the flexibility of postprandial dosing could offer advantages for children with inconsistent eating patterns or concerns about privacy surrounding insulin administration. They further discuss the utility of inhaled insulin for rapid glucose corrections, noting that additional doses can be administered far sooner than with traditional injected rapid-acting insulin.The episode concludes with discussion of anticipated affordability initiatives from MannKind Corporation, including bridge programs designed to improve early access and reduce financial barriers to therapy. Isaacs and Bellini commend the company's efforts to secure pediatric approval and express optimism that broader availability of inhaled insulin will expand individualized treatment options, improve patient satisfaction, and enhance quality of life for children and adolescents living with diabetes.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: HOLDER

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss several major developments in diabetes technology and obesity therapeutics, beginning with Abbott's announcement that its dual glucose-ketone monitoring systems, Libre Duo and Libre Duo 10 Day, have received CE mark approval in Europe. The hosts describe the devices as the first continuous glucose-ketone monitors capable of simultaneously measuring glucose and ketone levels through a single wearable sensor, with real-time ketone monitoring intended to identify rising risk for diabetic ketoacidosis (DKA). Bellini explains the rationale for separate 15-day adult and 10-day pediatric sensors, noting higher sensor failure rates and greater activity levels in children. Both hosts emphasize the potential clinical significance of continuous ketone monitoring, particularly for individuals with type 1 diabetes (T1D) using insulin pumps, where interruptions in insulin delivery can rapidly precipitate DKA.The discussion further explores how continuous ketone monitoring may expand the safe use of SGLT2 inhibitors in people with T1D and other high-risk populations. Bellini highlights concerns surrounding euglycemic DKA associated with SGLT2 inhibitor therapy and suggests that continuous ketone data could help clinicians identify susceptible individuals earlier, potentially enabling safer and more individualized dosing strategies. Isaacs underscores the limitations of current ketone testing methods, particularly urine ketone testing, which she characterizes as outdated and insufficient for modern diabetes management. The hosts also review additional patient populations that may benefit from continuous ketone monitoring, including individuals with recurrent DKA, pediatric patients with highly variable glycemic patterns, and hospitalized patients at elevated risk for ketosis due to prolonged fasting or treatment interruptions.Isaacs and Bellini also consider practical questions surrounding implementation, including reimbursement, cost, workflow integration, and compatibility with automated insulin delivery systems. They discuss whether continuous ketone monitoring could eventually become standard of care in T1D and debate the broader implications of widespread ketone data availability, including potential consumer interest outside traditional diabetes populations. Both hosts stress the importance of prioritizing access for patients at highest risk for DKA while acknowledging that broader adoption could reshape diabetes monitoring paradigms similarly to the evolution of continuous glucose monitoring.The episode then turns to recent reports involving Dexcom sensors that were reportedly stolen after being removed from the manufacturing process for quality concerns. Bellini explains that some of the affected sensors may not have completed sterility and quality assurance procedures before entering secondary markets. The hosts caution clinicians to review affected lot numbers and encourage ongoing vigilance until additional information becomes available. They also discuss the challenges of communicating recalls and safety alerts directly to patients, particularly for users relying on standalone receivers that may not connect to cloud-based notification systems.Finally, Isaacs and Bellini review newly released topline results from the phase 3 TRIUMPH-1 trial evaluating retatrutide, Lilly's investigational triple agonist targeting GLP-1, GIP, and glucagon receptors. Bellini summarizes findings demonstrating substantial weight reduction among adults with obesity or overweight without diabetes, including mean weight loss exceeding 28% at 80 weeks and continued weight reduction through 104 weeks without evidence of plateau. The hosts note that nearly half of participants achieved at least 30% weight loss, approaching outcomes historically associated with bariatric surgery. They also highlight low discontinuation rates and discuss the implications of future TRIUMPH studies evaluating retatrutide in patients with type 2 diabetes and cardiovascular disease. Isaacs concludes that the emerging data signal a transformative shift in obesity treatment, with pharmacologic therapies increasingly approaching surgical efficacy and potentially reshaping long-term obesity management strategies.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this special in-studio episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reflect on major themes and anticipated developments ahead of the upcoming American Diabetes Association (ADA) Scientific Sessions 2026.The discussion opens with Bellini congratulating Isaacs on receiving the ADA Outstanding Educator in Diabetes Award, prompting a conversation centered on Isaacs' forthcoming presentation, “Behind Every Number Is a Story: Transforming Diabetes Care and Education through Technology and Human Connection.” Isaacs reflects on the rapid evolution of diabetes technology over the last decade, from limited continuous glucose monitoring (CGM) access and the emergence of early automated insulin delivery (AID) systems to the integration of artificial intelligence into diabetes care, while emphasizing that successful care remains grounded in human connection and individualized patient experiences.The hosts then preview several therapeutic areas expected to dominate discussion at ADA, particularly the expanding pipeline of incretin-based therapies. Bellini and Isaacs discuss growing excitement surrounding GLP-1, GIP, and glucagon receptor agonists, including anticipated data from triple agonist agents such as retatrutide and emerging oral therapies like orforglipron. They highlight the significance of improved weight-loss efficacy in people with type 2 diabetes (T2D), broader cardiometabolic applications, and the increasing importance of treatment accessibility and affordability. The conversation also explores the expanding role of these therapies in addressing cardiovascular disease, chronic kidney disease, sleep apnea, osteoarthritis, and other obesity-related comorbidities.Technology advancements represent another major focus of the episode. Isaacs and Bellini discuss new CGM-driven insulin titration tools, including Dexcom's Smart Basal feature, designed to address therapeutic inertia among people with T2D using basal insulin. They also examine the growing role of CGM in broader patient populations and discuss evolving ADA recommendations supporting CGM access for any individual likely to benefit from the technology. The hosts express particular enthusiasm for the anticipated arrival of continuous ketone monitoring, including dual glucose-ketone sensors, and consider how these devices may transform diabetic ketoacidosis prevention and patient education, particularly for individuals with type 1 diabetes (T1D).The conversation also highlights continued innovation in insulin delivery systems and connected diabetes devices. Isaacs and Bellini discuss progress toward fully closed-loop AID systems, including ongoing studies evaluating meal-unannounced insulin delivery in T2D. They review emerging insulin pump technologies from Medtronic, including updates to the MiniMed platform and the integration of connected insulin pen systems with real-time CGM data through the MiniMed Go app. The hosts emphasize the importance of preserving therapeutic choice for people who prefer injections over pump therapy or who seek temporary alternatives to wearable devices.Toward the conclusion of the episode, both hosts preview their own ADA presentations. Isaacs discusses an upcoming session on inhaled insulin that will use simulated patient scenarios to explore shared decision-making and individualized therapy selection. Bellini highlights her session focused on skin complications related to diabetes technologies, including allergic reactions and adhesive-related challenges that can interfere with sustained device use. Together, they underscore the importance of addressing practical barriers to technology adoption while continuing to expand therapeutic and technological options for people living with diabetes.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss a slew of advances in diabetes technology and treatments, starting with the US Food and Drug Administration (FDA)'s recent approval of the Tandem automated insulin delivery system for use during pregnancy in individuals with type 1 diabetes. The conversation centers on findings from the CIRCUIT trial, which demonstrated significant improvements in time in range among pregnant patients, a population historically challenging to manage because of stringent glycemic targets. Isaacs and Bellini review practical considerations from the study, including the use of continuous sleep mode to target tighter glucose ranges and proactive optimization of basal rates, correction factors, and carbohydrate ratios to improve outcomes. They emphasize that FDA approval now allows clinicians and manufacturers to openly discuss evidence-based best practices for pregnancy management using automated insulin delivery systems.The hosts also highlight the importance of clinician comfort with aggressive insulin automation during pregnancy, noting that increased basal modulation, suspensions, and automated adjustments should be expected as physiologic insulin needs fluctuate throughout gestation. Bellini stresses the importance of reducing patient burden while maintaining intensive glycemic management, tying this theme into Tandem's newly announced compatibility with the Dexcom G7 15-day sensor. Both hosts note strong patient enthusiasm for extending sensor wear time, framing reduced device maintenance as an important quality-of-life improvement even when the practical change appears modest.The discussion then shifts to immunotherapy in type 1 diabetes, focusing on the expanded approval of teplizumab to include children as young as 1 year old for delaying progression from stage 2 to stage 3 disease. Isaacs and Bellini underscore how broader eligibility may strengthen adoption of autoantibody screening among relatives of patients with type 1 diabetes. They review evidence showing that screening substantially lowers rates of diabetic ketoacidosis at diagnosis and discuss the broader clinical significance of delaying symptomatic disease onset, even when delays are shorter than the median duration reported in trials. The hosts note that many families value the possibility of a more gradual transition into insulin dependence, often requiring only minimal insulin therapy initially rather than presenting with severe metabolic decompensation.The conversation also addresses ongoing regulatory developments surrounding teplizumab for newly diagnosed stage 3 type 1 diabetes. Although the anticipated expedited review pathway has been withdrawn, the hosts remain optimistic about eventual approval, citing encouraging data and the growing role of precision medicine approaches in identifying patients most likely to benefit from immune intervention.To conclude the episode, Isaacs and Bellini examine a post hoc analysis from the SURMOUNT-5 trial comparing tirzepatide and semaglutide in adults with obesity and prediabetes. They discuss findings showing high rates of reversion to normoglycemia in both treatment groups, with tirzepatide demonstrating greater efficacy overall. The hosts frame these data within the broader movement to reconceptualize prediabetes as an earlier stage of type 2 diabetes and cardiovascular disease risk rather than a benign precursor state. They emphasize the potential value of earlier therapeutic intervention to prevent progression and reduce long-term cardiometabolic complications while also acknowledging the importance of maintaining multiple treatment options because of variability in medication tolerability and patient response.Editors' Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Tandem Diabetes Care. Tandem Diabetes Care's Control-IQ+ Automated Insulin Delivery Technology Now FDA Cleared for Pregnancy in Type 1 Diabetes. April 27, 2026. Accessed May 8, 2026. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-cares-control-iq-automated-insulin-delivery2: Sanofi. Press Release: Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children. April 22, 2026. Accessed May 8, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-05-00-32786503: Galindo RJ, Aronne LJ, Horn DB, et al. Reversion to normoglycemia with tirzepatide vs semaglutide in participants with obesity and prediabetes: a post hoc analysis of SURMOUNT-5. J Endocrinol Invest. Published online April 20, 2026. doi:10.1007/s40618-026-02895-3

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!On March 26, 2026, the US Food and Drug Administration (FDA) approved Novo Nordisk's insulin icodec-abae under the name Awiqli for patients with type 2 diabetes (T2D).1,2In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, highlight the FDA approval of once-weekly insulin icodec, emphasizing its significance as a major advancement in insulin therapy. They begin by addressing practical considerations, including its high concentration (U-700) and the implications for dosing, noting that weekly administration necessitates substantially higher unit doses compared with daily basal insulin.The discussion focuses on dosing strategy, particularly the need to scale weekly doses approximately sevenfold relative to daily regimens, as well as the rationale for an initial loading dose of 1.5 times the calculated weekly requirement to more rapidly achieve steady state. Isaacs underscores the pharmacokinetic basis for this approach, given the drug's long half-life and delayed time to steady state, while also noting the constraints of dosing in 10-unit increments.Bellini and Isaacs explore the clinical implications of once-weekly insulin, with particular attention to adherence and treatment burden. Bellini emphasizes the potential benefit for insulin-naive patients and those struggling with daily injection adherence, framing weekly insulin as a means to significantly reduce injection frequency and improve consistency. Isaacs expands on this, arguing that reduced dosing frequency may mitigate missed doses and glycemic variability, especially in patients with irregular routines. Both highlight the flexibility afforded by the long half-life, allowing for minor deviations in dosing timing without substantial impact on glycemic control.The conversation also addresses potential risks, including delayed titration and the possibility of over-basalization, particularly in patients with fluctuating nutritional intake or socioeconomic instability. They stress the importance of careful patient selection and monitoring, given the longer interval required to adjust doses.Reviewing clinical trial data from the ONWARDS phase 3 program, the hosts note that once-weekly insulin demonstrated modestly greater A1C reduction compared with daily basal insulin in treat-to-target trials, reinforcing the hypothesis that improved adherence may translate into better glycemic outcomes.They further discuss implementation considerations across care settings, highlighting potential advantages for older adults, caregivers, and patients in long-term care, where reduced injection burden may improve safety, independence, and medication management. The episode also touches on current regulatory limitations, noting that while approval is presently limited to type 2 diabetes in the United States, ongoing studies may expand its indication to type 1 diabetes, with off-label use anticipated in select cases.The hosts conclude by situating weekly insulin within the broader therapeutic landscape, emphasizing renewed innovation in insulin development alongside incretin-based therapies. They note that additional agents in development may soon expand options within this class, signaling a meaningful shift in the management of diabetes toward more patient-centered, lower-burden treatment paradigms.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Novo Nordisk. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. March 26, 2026. Accessed April 3, 2026. https://ml-eu.globenewswire.com/Resource/Download/cb9dda59-1286-4718-a7e5-4256e2397b0c2: Kunzmann K. FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes. HCPLive. March 26, 2026. Accessed April 3, 2026. https://www.hcplive.com/view/fda-approves-awiqli-insulin-icodec-first-once-weekly-basal-insulin-for-type-2-diabetes

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!On March 17, 2026, the American Association of Clinical Endocrinology (AACE) released a consensus statement, which features an algorithm for the management of type 2 diabetes (T2D) in adult patients.1In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review the newly released 2026 American Association of Clinical Endocrinology (AACE) type 2 diabetes treatment algorithm, positioning it as an evolution of the 2023 update that integrates a growing body of clinical trial evidence into a more comprehensive, complications-focused framework. They emphasize a paradigm shift away from glucose-centric management alone, highlighting the importance of addressing comorbidities, including cardiovascular disease, chronic kidney disease, obesity, obstructive sleep apnea, and metabolic dysfunction–associated steatotic liver disease (MASLD), as central to optimizing outcomes.The discussion outlines the guideline's structure, including its 10 guiding principles, which reinforce lifestyle intervention as foundational, promote individualized glycemic targets (with a preference for A1c ≤6.5% when safely achievable), and strongly encourage early use of continuous glucose monitoring (CGM). The hosts underscore the emphasis on avoiding therapeutic inertia, minimizing hypoglycemia risk, and managing cardiometabolic comorbidities alongside glycemia as part of routine care.A key highlight is the introduction of a diabetes classification algorithm aimed at reducing misdiagnosis, particularly distinguishing type 1 from type 2 diabetes and identifying less common etiologies. Within this framework, the guidelines newly prioritize screening for hypercortisolism, informed by findings from the CATALYST trial, which demonstrated a higher-than-expected prevalence among patients with difficult-to-control diabetes. Isaacs and Bellini note that recognizing and treating underlying hypercortisolism may significantly improve glycemic control and, in some cases, reduce the need for diabetes-specific therapies.The episode further reviews updated algorithms for cardiovascular risk reduction, dyslipidemia, and hypertension, emphasizing aggressive, individualized targets and the continued central role of lifestyle modification. Pharmacologic recommendations reflect robust recent evidence, prioritizing SGLT2 inhibitors and GLP-1 receptor agonists (including dual GIP/GLP-1 agents) for patients with cardiorenal or metabolic comorbidities, while also incorporating emerging indications such as heart failure with preserved ejection fraction and MASLD.Isaacs and Bellini also discuss the guideline's glucose-centric algorithm for patients without major comorbidities, highlighting patient-centered decision-making based on factors such as hypoglycemia risk, weight considerations, and cost/access. They reinforce recommendations for early combination therapy when A1c is significantly above target and appropriate use of insulin, including guidance on avoiding overbasalization and incorporating prandial strategies.The conversation concludes with commentary on the guideline's practical strengths, including clear visual algorithms, concise format, and detailed pharmacotherapy tables summarizing efficacy, safety, and organ-specific benefits. The hosts emphasize that the updated AACE algorithm provides clinicians with an actionable, evidence-based roadmap for delivering holistic, individualized diabetes care that extends beyond glycemic control to address the full spectrum of cardiometabolic risk.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.ReferencesSamson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology Consensus Statement: Algorithm for Management of Adults With Type 2 Diabetes - 2026 Update. Endocr Pract. Published online March 17, 2026. doi:10.1016/j.eprac.2026.01.006

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!The US Food and Drug Administration (FDA) has approved orforglipron (Foundayo), a once-daily oral GLP-1 RA, for chronic weight management in adults with obesity or overweight and ≥1 weight-related comorbidity.1In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's decision and the myriad new treatment opportunities afforded by orforglipron's clearance for entry into the market.The approval of orforglipron is supported by the phase 3 ATTAIN clinical development program, which includes 2 global, randomized, double-blind, placebo-controlled trials evaluating efficacy and safety over 72 weeks.¹ The ATTAIN-1 trial enrolled 3,127 adults with obesity or overweight without diabetes, while ATTAIN-2 enrolled more than 1,600 adults with obesity or overweight and type 2 diabetes.1In ATTAIN-1, participants receiving the highest dose of orforglipron achieved a mean weight reduction of approximately 12.4% from baseline at 72 weeks among those who remained on treatment, compared with 0.9% in the placebo group. Reported average absolute weight loss was 27.3 lb versus 2.2 lb, respectively. Across all randomized participants regardless of completion status, mean weight loss was 11.1% with orforglipron compared with 2.1% with placebo.1Secondary outcomes included improvements in cardiometabolic risk markers such as waist circumference, non–high-density lipoprotein cholesterol, triglycerides, and systolic blood pressure. However, detailed peer-reviewed data from ATTAIN-1 and ATTAIN-2 remain limited at the time of reporting, and full efficacy and safety results have not yet been widely published in the medical literature.The safety profile of orforglipron appears consistent with the GLP-1 receptor agonist class. Common adverse events include gastrointestinal symptoms such as nausea, diarrhea, constipation, vomiting, and abdominal pain. A boxed warning highlights a potential risk of thyroid C-cell tumors, based on findings observed with other GLP-1 receptor agonists in rodent studies, though human relevance remains uncertain.1,2The magnitude of weight loss observed with orforglipron in ATTAIN-1 appears clinically meaningful but may be modest relative to leading injectable agents. Cross-trial comparisons should be interpreted cautiously due to differences in study populations and designs. Additionally, treatment persistence rates and discontinuation due to adverse events will be important considerations in real-world use.Ongoing and planned studies are evaluating orforglipron across additional indications, including type 2 diabetes and other cardiometabolic conditions. Future comparative trials against established GLP-1 and dual incretin therapies may help define its role in treatment algorithms.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References1: Eli Lilly. FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. April 1, 2026. Accessed April 1, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill2: US Food and Drug Administration. FDA Approves First New Molecular Entity Under National Priority Voucher Program. April 1, 2026. Accessed April 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

Advances in artificial intelligence, automated insulin delivery, and sensor integration were central to discussions at the 2026 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), where clinicians highlighted how emerging technologies may further reduce diabetes management burden while improving glycemic outcomes.In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed key highlights from the meeting, with particular emphasis on AI-driven tools and evolving closed-loop systems.A major theme was the growing role of artificial intelligence, including the concept of “digital twins”—virtual models built from patient-specific data such as glucose trends, insulin dosing, and behavioral inputs. These models allow clinicians and patients to simulate therapy adjustments, such as changes in insulin sensitivity or basal rates, before applying them in practice. Data presented at the meeting suggested use of digital twin modeling improved time in range, whereas providing data feedback alone did not meaningfully change outcomes.The discussion also examined real-world performance data from newer automated insulin delivery platforms. Early data from the Twiist system demonstrated time in range approaching 76% to 77% across initial user cohorts, with higher time in range observed among individuals using lower glucose targets, albeit with an expected increase in hypoglycemia. Expanded analyses in larger populations showed similarly strong outcomes, reinforcing the importance of target selection and individualized system settings.Sensor performance and reliability also emerged as a key topic. Investigators presented data suggesting unrecognized infusion set occlusions may contribute to unexplained hyperglycemia, highlighting potential advantages of newer pump technologies designed to detect occlusions more rapidly. In parallel, comparative analyses of sensor integration in hybrid closed-loop systems demonstrated consistent glycemic outcomes across multiple sensor platforms, suggesting algorithm performance, rather than sensor variability alone, plays a dominant role in achieving time in range.Lastly, hosts shared early data from fully closed-loop systems in type 2 diabetes, including a small trial evaluating automated insulin delivery without meal bolusing. Participants achieved substantial improvements in time in range, increasing from approximately 44% at baseline to 68%, with minimal hypoglycemia. Although not yet achieving traditional glycemic targets, these findings underscore the potential for reducing patient burden while maintaining clinically meaningful glucose control.Editor's Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.References: Senseonics. First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear. Senseonics.com. Published March 14, 2026. Accessed March 18, 2026. https://www.senseonics.com/investor-relations/news-releases/2026/03-14-2026-141507610 Insulet Corporation. Insulet Presents Promising Study Results for Fully Closed-Loop Automated Insulin Delivery System for Adults with Type 2 Diabetes. Insulet.com. Published March 10, 2026. Accessed March 18, 2026. https://investors.insulet.com/news/news-details/2026/Insulet-Presents-Promising-Study-Results-for-Fully-Closed-Loop-Automated-Insulin-Delivery-System-for-Adults-with-Type-2-Diabetes/default.aspx

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, share early impressions of topline phase 3 results from the TRIUMPH-4 trial of retatrutide, a once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors.  Recorded from the ADCES Technology Conference, the conversation frames retatrutide as a potential next step beyond current GLP-1 and dual incretin options, while emphasizing that detailed trial data remain pending. TRIUMPH-4 was a phase 3 study enrolling patients with obesity and osteoarthritis. Topline data suggests participants receiving retatrutide 12 mg achieved a mean weight loss of 28.7% at 68 weeks. Among this population, the trial also reported a 75.8% reduction in WOMAC pain scores from baseline, with approximately 1 in 8 participants reporting complete pain freedom at week 68. Isaacs highlights how striking these figures are in light of the already high bar set by semaglutide and tirzepatide, noting that confirmation in phase 3 heightens anticipation for full publications and future readouts. The hosts connect these findings to evolving clinical priorities reflected in the American Diabetes Association's expanding attention to obesity-related comorbidities, including osteoarthritis, MASLD/MASH, sleep apnea, and kidney disease. They note the broader retatrutide phase 3 program includes studies in type 2 diabetes, moderate-to-severe obstructive sleep apnea, chronic low back pain, MASLD/MASH, and planned cardiovascular and renal outcomes trials. Isaacs underscores the ongoing question of whether benefits across these conditions will be primarily molecule-specific or largely driven by the magnitude of weight loss, particularly given the inclusion of glucagon receptor activity. Safety is discussed cautiously, given the limited nature of top-line disclosures. The hosts note that discontinuation due to adverse events appeared higher with retatrutide than placebo, and they emphasize the need for full reporting on gastrointestinal tolerability and other adverse events. Bellini also points to an intriguing subgroup signal suggesting lower discontinuation rates among participants with higher baseline BMI, while acknowledging this could reflect chance in a modestly sized trial population. Overall, Isaacs and Bellini characterize retatrutide's TRIUMPH-4 update as an important milestone, while stressing that interpretation should remain measured until complete efficacy and safety data are available. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Eli Lilly and Company. Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial. December 11, 2025. Accessed December 11, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average American Diabetes Association. The American Diabetes Association Launches a New Obesity Division | ADA. diabetes.org. Published June 21, 2024. Accessed December 16, 2025. https://diabetes.org/newsroom/press-releases/american-diabetes-association-launches-new-obesity-division

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss major diabetes technology updates alongside key technology-related changes in the 2026 American Diabetes Association Standards of Care. The conversation highlights how rapidly evolving devices and updated guidelines are converging to reduce treatment burden and expand access to advanced diabetes management tools. The discussion opens with updates from Dexcom, notably the launch of the Dexcom G7 15-day sensor, which incorporates an updated algorithm and is already integrating with Omnipod 5 and iLet systems, with Tandem integration expected soon. The hosts also address the announcement that the Dexcom G6 will be retired in July 2026, acknowledging the emotional and practical challenges this poses for patients who prefer the G6's connectivity and perceived accuracy. While the transition may be difficult for some, the longer wear time and algorithm improvements of the G7 are framed as an opportunity to reassess CGM options and prepare thoughtfully for change. Attention then shifts to Omnipod 5, with anticipation around a forthcoming software update planned for 2026. This update will introduce a lower glucose target of 100 mg/dL, down from 110 mg/dL, and significantly reduce automated-mode “kick-outs.” The hosts emphasize that minimizing time out of automated insulin delivery is critical for improving time in range and lowering patient burden, noting that excessive safety-driven exits can paradoxically worsen glycemic control. A substantial portion of the episode is devoted to technology-focused updates in the 2026 ADA Standards of Care, reflecting Bellini's perspective as a guideline committee member. Key changes include the removal of C-peptide and autoantibody requirements as barriers to insulin pump and automated insulin delivery (AID) access, reinforcing that insulin use, not diabetes type, should guide eligibility. The guidelines now include a Level A recommendation for AID use in type 2 diabetes, supported by recent clinical trial data and regulatory approvals. Additional updates expand support for CGM use during pregnancy beyond type 1 diabetes, reduce reliance on confirmatory fingerstick language, and strengthen recommendations for connected insulin pens for individuals on multiple daily injections when AID is not preferred or feasible. The episode concludes with discussion of expanded guidance on open-source AID systems, underscoring the importance of clinician understanding and patient support regardless of FDA approval status. Collectively, Isaacs and Bellini frame the 2026 updates as a decisive step toward earlier, broader, and more individualized use of diabetes technology across care settings. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: American Diabetes Association. The American Diabetes Association Releases “Standards of Care in Diabetes—2026” | American Diabetes Association. Diabetes.org. Published December 8, 2025. Accessed December 17, 2025. https://diabetes.org/newsroom/press-releases/american-diabetes-association-releases-standards-care-diabetes-2026 American Diabetes Association Professional Practice Committee for Diabetes*. Summary of Revisions: Standards of Care in Diabetes-2026. Diabetes Care. 2026;49(1 Suppl 1):S6-S12. doi:10.2337/dc26-SREV Chapters 00:00:00 - Intro & Agenda: New Tech + 2026 ADA Standards 00:00:45 - Dexcom G7 15‑Day Sensor & G6 Retirement 00:04:40 - OmniPod Algorithm Update 00:09:27 - 2026 ADA Standards of Care 00:15:45 - Expanding Diabetes Tech Options 00:21:19 - Endorsement of Earlier AID and Open-Source AID Support

In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, breakdown recent trial news from the 2 most popular incretin therapies: semaglutide and tirzepatide. First, hosts breakdown the November 24, 2025 announcement from Novo Nordisk disclosing their evoke and evoke+ trials of oral semaglutide in early symptomatic Alzheimer Disease failed to slow disease progression. Next, hosts break down the TIRTLE study, which examined use of tirzepatide in patients with type 1 diabetes. Semaglutide Misses Mark in Alzheimer Disease Novo Nordisk announced top-line results from the evoke and evoke+ phase 3 trials showing oral semaglutide 14 mg did not slow disease progression over 2 years in adults with early symptomatic Alzheimerdisease, with no significant difference in CDR-SB change versus placebo. Despite improvements in Alzheimer-related biomarkers across both studies, neither trial demonstrated a slowing of clinical decline. evoke was a global, randomized, double-blind, placebo-controlled trial enrolling 1,855 participants aged 55–85 with amyloid-positive CDR 0.5 MCI or CDR 1.0 mild dementia, treated 1:1 with semaglutide or placebo for 104 weeks plus a planned 52-week extension. evoke+ mirrored this design, randomizing 1,953 participants with the same eligibility criteria to daily semaglutide 14 mg or placebo for a total planned duration of 156 weeks. Findings from the trials will be presented at the 2025 Clinical Trials in Alzheimer's Disease (CTAD) conference on December 3, 2025. The lack of efficacy led to discontinuation of the planned 1-year extension period across both trials, though safety and tolerability remained consistent with prior semaglutide experience in diabetes and obesity. TIRTLE: Tirzepatide Shows Benefit in Type 1 Diabetes In a 12-week, double-blind, placebo-controlled phase 2 trial of 24 adults with type 1 diabetes and BMI >30 kg/m², tirzepatide produced a 10.3-kg mean weight loss versus 0.7 kg on placebo, an −8.7-kg treatment difference (P < 0.0001) corresponding to 8.8% total body weight reduction. All tirzepatide-treated participants achieved ≥5% weight loss, and 45% achieved ≥10%, compared with 9% and 0% in the placebo group. Eligibility criteria required patients to be 18 years of age or older, with confirmed type 1 diabetes, obesity (BMI >30), and stable insulin therapy. Tirzepatide also improved glycemic control, reducing HbA1c by 0.4%, and decreased total daily insulin dose by 35% relative to placebo (−24.2 vs −0.3 units/day). Safety data suggested no significant adverse events occurred, with 22 of the 24 participants completing the study. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Novo Nordisk. Novo Nordisk A/S: Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer's disease progression. Novo Nordisk. November 24, 2025. Accessed November 24, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916462. Snaith JR, Frampton R, Samocha-Bonet D, Greenfield JR. Tirzepatide in Adults With Type 1 Diabetes: A Phase 2 Randomized Placebo-Controlled Clinical Trial. Diabetes Care. Published online November 20, 2025. doi:10.2337/dc25-2379

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: It's World Diabetes Day and we have a LOT of news to get to! Daily oral insulin tested to prevent T1D, mothers and sons and a T1D link, stem cell updates, Tandem Android news, Omnipod's workplace campaign and more! Find out how to submit your Community Commercial 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. It's world diabetes day! It is marked every year on 14 November, the birthday of Sir Frederick Banting, who co-discovered insulin along with Charles Best in 1922.   WDD was created in 1991 by International Diabetes Federation (IDF) and the World Health Organization and became an official United Nations Day in 2006 with the passage of United Nations Resolution 61/225. There will be a ton of stuff in your feeds today and that's great! I'm going to keep this to a pretty normal in the news episode.. although I do have my own World Diabetes Day announcement – I want YOUR community commercials. You could have an ad for your event or your blog or your project right here! There's a post on the website explaining it all and I'll come back at the end of the episode and tell you more. XX The Primary Oral Insulin Trial (POInT) is the first large-scale clinical trial to test whether giving at-risk children daily oral insulin could prevent or delay type 1 diabetes (T1D). Conducted by researchers from Helmholtz Munich and the Technical University of Munich across five European countries, the study enrolled more than 1,000 children with a genetic risk for T1D. Results published in The Lancet show that while oral insulin did not prevent the development of islet autoantibodies—an early sign of diabetes—it was safe and well tolerated. Importantly, researchers found that some children who received oral insulin developed diabetes more slowly than those given a placebo, suggesting potential protective effects in certain genetic subgroups.   Further analysis revealed that the response to treatment depended on the child's insulin gene variant. Children with genetic versions that raise diabetes risk appeared to benefit, showing delayed onset of the disease, while those without the risk variant did not. These findings point toward a future of personalized prevention, where genetic screening could help identify which children might benefit most from oral insulin. Researchers will continue following the participants until age 12 to assess long-term effects. The study marks a major milestone in decades of diabetes prevention research, highlighting both the promise and complexity of developing tailored, early interventions against type 1 diabetes. XX Joint US-Chinese research looking at generating new beta cells from stomach cells. Upon turning on the "genetic switch," the human stomach cells were converted to insulin-secreting cells within the mice and resembled pancreatic beta cells with respect to gene and protein expression. Encouragingly, when those experiments were done with diabetic mice, insulin secreted from the transformed human cells helped control blood sugar levels and ameliorated diabetes. The scientists hope that a similar approach can be taken to convert cells from a patient's own stomach into insulin-secreting cells directly within the body. Importantly, additional studies are needed to address if this approach is safe and effective to be used in patients. https://www.technologynetworks.com/cell-science/news/human-stomach-cells-tweaked-to-make-insulin-406694 XX A new study in Nature Metabolism may help explain why children born to mothers with type 1 diabetes are less likely to develop the disease early in life compared to those whose fathers or siblings have it. Researchers looked at nearly 2,000 mothers and their children and found that  kids whose moms have type 1 diabetes show changes in their DNA that may actually help protect them. These aren't genetic mutations, but epigenetic changes — chemical tags that turn certain genes on or off. The study found these changes in genes tied to the immune system and type 1 diabetes risk, suggesting that a mother's condition during pregnancy can shape her child's immune response in a protective way. Scientists identified more than 500 areas of DNA where these changes occurred, many in regions that control how the body's immune system works. Most of the changes appeared to calm down the kind of overactive immune response that leads to type 1 diabetes. Researchers even created a "methylation score" to help measure this protective effect. They say the next step is to confirm these results in more diverse groups and figure out exactly how these DNA changes help prevent early diabetes. https://www.news-medical.net/news/20251110/Maternal-type-1-diabetes-may-protect-children-from-developing-the-disease.aspx XX A new study from Karolinska Institutet and Stockholm University reveals that sons born to mothers with type 1 diabetes may develop early vascular dysfunction—independently of metabolic health. The finding may help shape future strategies to prevent cardiovascular disease early in life.     Children of women with type 1 diabetes are known to be at increased risk of developing cardiovascular diseases. This new study, published in Cell Reports Medicine, is the first to show that the risk is linked to early dysfunction in blood vessel cells in sons, even before any metabolic issues arise. The team is now investigating the long-term effects of maternal diabetes, with a particular focus on why sons seem to be affected earlier than daughters. https://medicalxpress.com/news/2025-11-sons-mothers-diabetes-early-vascular.html XX A new study presented at Kidney Week 2025 has shown that the drug finn-uh-near-own  a nonsteroidal mineralocorticoid-receptor antagonist, significantly reduced albuminuria—a key marker of kidney damage—in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This is the first major breakthrough for this population in more than 30 years. Researchers found that patients taking finerenone saw a 25% average reduction in albuminuria compared to placebo, an improvement that suggests a lower long-term risk for dialysis or kidney transplant. The phase 3 FINE-ONE trial involved 242 adults with T1D and CKD, and results showed benefits as early as three months. The drug was generally well tolerated, with side effects similar to those seen in patients with type 2 diabetes, though mild hyperkalemia (high potassium levels) was slightly more common. Experts say the findings could change the way doctors treat kidney complications in type 1 diabetes, an area that hasn't seen new therapies since the early 1990s. Currently, treatment options rely on blood pressure and blood sugar management, along with renin-angiotensin system (RAS) inhibitors. Finerenone, which is already approved for type 2 diabetes-related CKD, targets overactivation of a receptor that drives kidney damage. Based on these results, Bayer plans to seek FDA approval in 2026 for use in people with T1D and CKD. Researchers and clinicians alike are calling the study "groundbreaking," noting that it opens the door to future research on how finerenone might not just slow kidney decline—but possibly prevent it altogether. https://www.medscape.com/viewarticle/finerenone-offers-hope-kidney-disease-type-1-diabetes-2025a1000uzi?form=login   XX This week, Tandem Diabetes Care (Nasdaq:TNDM) announced a major milestone for its Mobi miniature durable insulin pump system. San Diego-based Tandem revealed that it received FDA approval for the Android version of its Mobi mobile app. Clearance brings Mobi — which the company describes as the world's smallest, durable automated insulin delivery system — to more users. The pump, which pairs with Tandem's Control-IQ+ algorithm, previously worked with iOS software.   Tandem — one of the largest diabetes tech companies in the world — expects to begin a limited rollout next month, followed by full commercial availability in early 2026. This marks the latest milestone for the company, which continues to expand its offerings and widen its reach within the diabetes patient population.   We had a great interview with Tandem on our previous episode, but as I said at the time, it was coming before their earnings call. So here's an update: The company plans to submit the tubeless mobi to the fda before the end of this year.. possible approval and shipping date is hoped for by middle of 2026. Trials for their fully closed loop next-generation algorithm which we tlkaed abou ton the show should be launched in 2026 The Sigi patch pump will be developed and launched as a next-generation version of the Mobi Great job by Dr. David ? Ahn – he posted on IG after getting a message from tandem CEO John Sheridan? 1. First, the Tandem X3 *is* still absolutely in development, contrary to my speculation In yesterday's video. As many of you appropriately pointed out, there is definitely a market for a 300 unit pump, a pump with a screen, and a pump that does not require smartphone control. So from our brief chat, the sense I got that is that the X3 would be more of a refresh of the X2 with newer components, such as a USB-C connector and better memory, rather than a total redesign from the ground up. In terms of timing, all I could get was that it was "not too far distant in the future," which could mean anything I guess, but at least it's still on the way! 2. Next up, he also reassured me that they are working closely with Dexcom to support the G7 15 Day sensor within the next few months. I suspected as much, but it's always good to hear confirmation. 3. Lastly, he did confirm that Tandem is far along in developing a Caregiver/Follow app to allow the remote viewing of glucose and insulin data from a Tandem pump. He explained that it will be based on Sugarmate, the popular diabetes data dashboard app that Tandem acquired back in Jun 2020. While I don't know if every feature will make it into the Tandem caregiver app, Sugarmate is well-liked for its highly customizable dashboard and highly configurable alerts. Sugarmate even has the option to send a text message or phone call for urgent lows. Regardless, a true follow/Caregiver app will be welcomed with open arms by all caregivers and Tandem users who use Libre 3 Plus. https://time.com/7318020/worlds-top-healthtech-companies-2025/ XX Senseonics submits Eversense 365 – their year long implantable CGM for a CE mark, European Approval and expect to launch there soon. Eversense will be integrated with the sequel twist pump – again I'm hearing soon but no timeline. Intersting to note that one year inseration was approved in the US just about a year ago, so the first patients will be having their CGMs changed out – for the first time – pretty soon. https://www.drugdeliverybusiness.com/senseonics-q2-2025-sales-beat-ce-mark/ XX A confusing study out of Rutgers - these researcher say  metformin reduces some of the key benefits normally gained from regular physical activity. These include improvements in blood vessel health, physical fitness, and the body's ability to regulate blood sugar. Since 2006, doctors have typically encouraged patients with elevated blood sugar levels to combine metformin with exercise, expecting that the two proven treatments would produce stronger results together. However, the new research suggests this may not be the case. In this study, Exercise alone improved vascular insulin sensitivity, meaning blood vessels responded better to insulin and allowed more blood flow to muscles. This matters because insulin's ability to open blood vessels helps shuttle glucose out of the bloodstream and into tissues, lowering blood sugar after meals. But when metformin was added, the improvements shrank. The drug also diminished gains in aerobic fitness and reduced the positive effects on inflammation and fasting glucose. The findings don't mean people should stop taking metformin or exercising, Malin said. Instead, it raises urgent questions for doctors about how the two treatments can be combined and the need for close monitoring. Malin hopes future research will uncover strategies that preserve the benefits of both. https://scitechdaily.com/popular-diabetes-drug-metformin-may-cancel-out-exercise-benefits-study-warns/ XX XX https://www.medtechdive.com/news/Revvity-Sanofi-diabetes-test-Kihealth-seed-round/802133/   XX Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly. The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30. The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version. Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind. Dexcom sent a notification to customers in September about the software bug, which applies to version 1.15 of the G6 Android app. To use the app, customers must update it to a new version, according to the entry. https://www.medtechdive.com/news/dexcom-recall-g6-cgm-app/804630/ XX https://www.medscape.com/viewarticle/automated-insulin-delivery-boosts-glycemic-control-youth-2025a1000ub3 XX Tidepool partners with smart ring maker OURA.. press release says: to support a groundbreaking dataset intended to be broadly available for diabetes research, with participation limited to individuals who opt in through Tidepool.         Tidepool will pair biometric data from Oura Ring – sleep, activity, heart rate, temperature trends, and menstrual cycles – with diabetes device data, including continuous glucose monitors (CGMs) and insulin pumps. The result will provide researchers with an unprecedented dataset to accelerate the development of new clinical guidelines, next-generation diabetes technology, and personalized care models.   Recruitment is expected to launch in early 2026 through an IRB-approved study. By opting in to this study, participants consent to sharing their data with Tidepool's Big Data Donation Project, where data is de-identified and, with participant consent, shared with academics, researchers, and industry innovators to accelerate diabetes research. https://aijourn.com/tidepool-collaborates-with-oura-to-advance-inclusive-diabetes-research-through-wearables/ XX Eli Lilly launches two new clinical trials for baricitinib. These phase 3 trials will investigate whether the drug can delay T1D onset or progression and will open for recruitment soon. Baricitinib has the potential to extend the "honeymoon period" of T1D, meaning that it could preserve remaining insulin-producing beta cells earlier in disease progression. More beta cells mean better blood sugar management—and potentially reduced long-term complications. JAK inhibitors, including baricitinib, are already FDA-approved for other autoimmune diseases, such as rheumatoid arthritis, alopecia, and more. JAK signaling pathways are associated with overactive immune responses, so blocking this pathway may turn down the immune response. The phase 2 Breakthrough T1D-funded BANDIT study was key in showing that this drug is safe and effective in T1D. Importantly, baricitinib is a once-daily oral pill—meaning its use is simple and easy.   https://www.breakthrought1d.org/news-and-updates/two-new-trials-baricitinib-to-delay-t1d/ XX   Insulet is taking diabetes awareness into the workplace. Having found 79% of people with diabetes have faced bias or misunderstanding at work, the medtech giant is rolling out a range of resources intended to trigger changes in how workplaces approach the condition. Lots going on for Diabetes Awareness month.. some notables.. Insulet's "The Day Diabetes Showed up to Work" campaign. based on a survey of almost 10,000 people 79% of people with diabetes have faced bias or misunderstanding at work,.   Almost 90% of people with diabetes surveyed reported experiencing barriers at work due to their condition, and more than 40% of people with diabetes and caregivers said they have workplace-related anxiety tied to the metabolic disease. Around one-quarter of respondents reported fears that diabetes could limit opportunities or lead to workplace discrimination and judgment, and a similar proportion of people said they conceal their condition. https://www.fiercepharma.com/marketing/widespread-workplace-challenges-people-diabetes-spark-insulet-campaign XX New directive issued by the Trump administration could mean people seeking visas to live in the U.S. might be rejected if they have certain medical conditions, including diabetes or obesity.   The guidance, issued in a cable the State Department sent to embassy and consular officials and examined by KFF Health News, directs visa officers to deem applicants ineligible to enter the U.S. for several new reasons, including age or the likelihood they might rely on public benefits.   The guidance says that such people could become a "public charge" — a potential drain on U.S. resources — because of their health issues or age.   The cable's language appears at odds with the Foreign Affairs Manual, the State Department's own handbook, which says that visa officers cannot reject an application based on "what if" scenarios, Wheeler said.   The guidance directs visa officers to develop "their own thoughts about what could lead to some sort of medical emergency or sort of medical costs in the future," he said. "That's troubling because they're not medically trained, they have no experience in this area, and they shouldn't be making projections based on their own personal knowledge or bias."   Immigrants already undergo a medical exam by a physician who's been approved by a U.S. embassy. https://www.npr.org/2025/11/12/nx-s1-5606348/immigrants-visas-health-conditions-trump-guidance XX SAN DIEGO---Nov. 14, 2025—DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, today unveiled 16 new diabetes advocates to represent people living with diabetes globally as part of Dexcom's World Diabetes Day campaign. The advocates – ranging from ages six to 68, spanning various types of diabetes, and hailing from four continents and five countries – were selected from 1,000 open call submissions based on their experiences advocating for people with diabetes in their communities. While each person's experience with diabetes is unique, they share a common passion for advocacy – and use of Dexcom's glucose biosensing technology. "Through advocacy, I strive to show others, especially children and newly diagnosed patients, that diabetes is not a limitation but an opportunity to grow stronger, inspire resilience and pursue ambitious goals," said Maria Alejandra Jove Valerio, one of Dexcom's new advocates. "What began as a diagnosis at age seven has grown into a lifelong mission to uplift others." This effort represents the first time Dexcom has sourced voices from the broader diabetes community specifically for its World Diabetes Day campaign, reinforcing Dexcom's history of and commitment to giving real people with diabetes a platform to share their story on a global stage. Through engaging, editorial-style portraits and deeply personal stories, the campaign highlights each advocate's personal experience with diabetes, what misconceptions about diabetes they'd like to dispel and how they want to inspire others with diabetes to discover what they're made of. To prepare for the spotlight, the group of advocates met in Los Angeles for a World Diabetes Day photoshoot which included a surprise visit from Grammy-nominated artist, actor, producer and Dexcom Warrior Lance Bass and author, producer, actress and Stelo*Ambassador Retta. This visit offered the advocates an opportunity to exchange stories and personal perspectives on the meaning of diabetes advocacy and how they live it each day. Behind the lens at the shoot was another member of the diabetes community—photographer Tommy Lundberg who lives with Type 1 diabetes. "Directing this photoshoot was nothing short of inspiring. Each of these advocates has a unique an XX On what would have been the 100th birthday of its visionary founder Alfred E. Mann, MannKind Corporation (Nasdaq: MNKD), in partnership with Alfred E. Mann Charities and The Diabetes Link, announced the launch of the Centennial Al Mann Scholarship. The new program will distribute $100,000 in scholarship funds to support at least 10 young adult students living with diabetes as they pursue higher education in life sciences.   Launched in Diabetes Awareness Month, the scholarship program honors Alfred E. Mann's enduring legacy of innovation, philanthropy, and his lifelong commitment to improving the quality of human life through medical advancement. Deeply passionate about giving back, Mr. Mann believed that his success should continue to serve humanity long after his passing, a belief that lives on through this initiative.   Each scholarship recipient will be awarded up to $10,000, distributed in annual installments of $2,500 throughout the course of their studies. Depending on the length of their degree program, recipients may receive between two and four installments (up to the full $10,000 per student). The first awards will be made for the 2026 academic year.   "Al Mann dedicated his life to helping people with serious medical conditions live longer, healthier lives. This scholarship is a reflection of that spirit," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "By supporting students living with diabetes who are pursuing careers in the life sciences and adjacent fields, we're honoring Al's legacy and investing in the future of innovation and care. This program is about giving back to the community we serve and empowering the next generation to carry forward Al's mission of making a meaningful difference in people's lives."   Alfred E. Mann Charities and MannKind will partner with The Diabetes Link to launch the program to serve young adults (aged 18-22) living with either type 1 or type 2 diabetes with their higher education goals. Those eligible will include incoming freshmen and current students pursuing 2- or 4-year degrees. The application window will open in early 2026, and for those interested in receiving notifications, an early interest form is available. More information about the scholarship will be shared on thediabeteslink.org.   "We're honored to partner with MannKind to expand access to higher education for young adults with diabetes," said Manuel Hernández, Chief Executive Officer of The Diabetes Link. "At a time when the cost of college continues to rise, this scholarship helps ease the financial burden and carries forward the spirit of Al Mann, whose vision and legacy continue to inspire us."   Mr. Mann was MannKind's Chairman of the Board from 2001 until his passing in February 2016 and served as Chief Executive Officer from November 2003 until January 2015. Driven by a desire to improve lives and fill unmet medical needs, for more than six decades he founded 17 companies and developed breakthrough medical devices, including insulin pumps, cochlear implants, cardiac pacemakers and retinal prostheses. In 1997, Mr. Mann saw the potential of a dry powder insulin formulation to change the way diabetes is treated and invested nearly $1 billion to help bring Afrezza® (insulin human) Inhalation Powder to market.   About MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.   With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.   Learn more at mannkindcorp.com.   About Alfred E. Mann Charities, Inc. Alfred E. Mann Charities, Inc. became active in 2016, following the passing of the organization's benefactor, Alfred E. Mann. Throughout his life, Al was passionate about philanthropy and was dedicated to prolonging and improving the quality of human lives through innovation in the fields of healthcare and the use of medical devices. It was important to Al that his success and assets continue to better human lives even after his own passing.   Alfred E. Mann Charities, Inc. (formerly known as Alfred E. Mann Family Foundation) has similarly placed its primary focus on healthcare and medical innovation, as our organization believes this is where we can have the greatest impact on humanity and human health throughout the world. Alfred E. Mann Charities, Inc. is also dedicated to promoting arts, culture, education, and community development across Los Angeles and throughout the world in order to best serve people and this planet.   Learn more at aemanncharities.org.   About The Diabetes Link The Diabetes Link is the only national nonprofit organization dedicated to empowering young adults living with diabetes. Founded by and for young adults, The Link serves this community through peer support, leadership opportunities, and practical, evidence-based resources designed for real life. Its network of campus and community chapters, active online community, and robust Resource Hub help young adults navigate the transitions of early adulthood while managing diabetes. The organization envisions a future where every young adult living with diabetes has

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for October 12-18, 2025: 1. FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes The FDA accepted MannKind's sBLA for Afrezza inhaled insulin to expand its use to children and adolescents with type 1 or type 2 diabetes. 2. FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD The FDA broadened upadacitinib's indication to allow use in ulcerative colitis and Crohn disease when tumor necrosis factor blockers are not clinically appropriate. 3. FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology The FDA cleared Elecsys pTau181 as the first blood test to help rule out Alzheimer-related amyloid pathology in older adults with cognitive symptoms. 4. Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial A phase 3 study showed a prescription digital therapeutic significantly reduced negative symptoms in schizophrenia when used alongside antipsychotic therapy. 5. APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint Iptacopan demonstrated meaningful efficacy in slowing kidney function decline in adults with IgA nephropathy, supporting future regulatory submissions.

At ESC 2025, a pair of presentations highlighted the ongoing debate over cardiovascular risk reduction with semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound), yielding conflicting signals that clinicians will need to interpret carefully. In this special edition episode, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore these studies: SURMOUNT-5 and STEER. A post hoc analysis of SURMOUNT-5 compared the 10-year predicted CV risk reduction between the 2 agents. Using the Framingham Risk Calculator in 751 patients with obesity, tirzepatide was associated with greater benefit than semaglutide. From baseline risks of ~9%, tirzepatide was projected to lower absolute 10-year CV risk by 2.4% (23% relative reduction) compared with 1.4% (13% relative reduction) for semaglutide. Investigators attributed the advantage largely to greater weight and glycemic reductions. In contrast, the STEER study, a real-world analysis of more than 21,000 patients with a mean follow-up of 8.5 months, suggested semaglutide was associated with lower rates of major adverse cardiovascular events (MACE) than tirzepatide. Semaglutide users had a 29% risk reduction in nonfatal MI, nonfatal stroke, or CV death compared with tirzepatide. Limitations included short follow-up, relatively few CV events, and the inherent confounding of observational data. Both Isaacs and Bellini emphasized that while weight and glycemic improvements with tirzepatide appear robust, CV benefits may be molecule-specific. The ongoing SURPASS-CVOT, comparing tirzepatide with dulaglutide, should provide more clarity when full data are released at EASD. In the interim, the hosts advised prescribing based on labeled indications supported by randomized outcomes data—semaglutide for CV and kidney risk reduction, tirzepatide for obesity and sleep apnea—while awaiting definitive trial results. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Mamas M. SURMOUNT-5: Tirzepatide compared to Semaglutide in obesity for 10-year CVD risk reduction .Presented at the European Society of Cardiology (ESC) Congress 2025. Madrid, Spain. August 29- September 1, 2025. Novo Nordisk. Novo Nordisk's Wegovy® cuts risk of heart attack, stroke or death by 57% compared to tirzepatide in real-world study of people with obesity and cardiovascular disease. Novo Nordisk. Published August 31, 2025. Accessed September 5, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916422

 It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: cancer reserach may lead to T1D treatment, GLP-1 oral pill moves forward, Tandem pharmacy moves, Medtronic-Abbott sensor unveield, parents of kids with T1D see income drop, Mannkind submits Afrezza for pediatrics, diabetes scholarships 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 Cornell researchers have developed an implant system that can treat type 1 diabetes by supplying extra oxygen to densely packed insulin-secreting cells, without the need for immunosuppression. The system could also potentially provide long-term treatment for a range of chronic diseases. This lab has produced previous implantable devices that have proved effective in controlling blood sugar in diabetic mice, but they can only last so long. "It's the proof of concept. We really proved that oxygenation is important, and oxygenation will support high cell-density capsules," Tempelman said. "The capsules are immune protective and last for a long time without having some kind of fouling of the membrane. The body never likes it when you put a foreign substance in. So that's the engineering in the Ma Lab, to look for materials and coatings for the materials that are immune protective, but also don't invoke excess response from the body because of the material." The next step will be to implant the system in a pig model, and also test it with human stem cells. The researchers are interested in eventually trying to use the system for implanting different cell types in humans for long-term treatment of chronic diseases, according to Tempelman, who is CEO of Persista Bio Inc., a new startup she founded with Ma and Flanders that is licensing these technologies. https://medicalxpress.com/news/2025-08-implant-diabetes-oxygenating-insulin-cells.html XX Mayo Clinic cancer research may be big news for T1D. After identifying a sugar molecule that cancer cells use on their surfaces to hide from the immune system, the researchers have found the same molecule may eventually help in the treatment of type 1. Cancer cells use a variety of methods to evade immune response, including coating themselves in a sugar molecule known as sialic acid. The researchers found in a preclinical model of type 1 diabetes that it's possible to dress up beta cells with the same sugar molecule, enabling the immune system to tolerate the cells. The findings show that it's possible to engineer beta cells that do not prompt an immune response   In the preclinical models, the team found that the engineered cells were 90% effective in preventing the development of type 1 diabetes. The beta cells that are typically destroyed by the immune system in type 1 diabetes were preserved.     https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-researchers-find-sugar-coating-cells-can-protect-those-typically-destroyed-in-type-1-diabetes/ XX A daily pill may be as effective in lowering blood sugar and aiding weight loss in people with Type 2 diabetes as the popular injectable drugs Mounjaro and Ozempic, according to results of a clinical trial announced by Eli Lilly on Thursday morning.   The drug, orforglipron, is a GLP-1, a class of drugs that have become blockbusters because of their weight-loss effects. But the GLP-1s on the market now are expensive, must be kept refrigerated and must be injected. A pill that produces similar results has the potential to become far more widely used, though it is also expected to be expensive.   Lilly said it would seek approval from the Food and Drug Administration later this year to market orforglipron for obesity and early in 2026 for diabetes. https://www.nytimes.com/2025/04/17/health/pill-glp-1-eli-lilly.html XX Use of diabetes technology has dramatically increased and glycemic control has improved among people with type 1 diabetes (T1D) in the US over the past 15 years, but at the same time, overall achievement of an A1c level < 7% remains low and socioeconomic and racial disparities have widened. These findings came from an analysis of national electronic health records of nearly 200,000 children and adults with T1D by Michael Fang, PhD, of the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. The study was published online on August 11, 2025, in JAMA Network Open. Use of continuous glucose monitors (CGMs) increased substantially from 2009-2011 to 2021-2023, from less than 5% in both children and adults to more than 80% and over half, respectively. While A1c levels did drop over the 15 years, just 1 in 5 children and slightly over a quarter of adults achieved a level < 7%. The average A1c level stayed above 8%, with ethnic minorities and low-income patients seeing the smallest gains.       https://www.medscape.com/viewarticle/diabetes-tech-use-rise-a1c-reductions-still-lag-2025a1000lc9 XX Inflammation may predict how well people with diabetes respond to depression treatment, and the effects differ dramatically between type 1 and type 2 diabetes. Diabetes and depression often appear together. Indeed, depression is more than three times more prevalent in people with type 1 diabetes (T1D) and nearly twice as prevalent in people with type 2 diabetes (T2D). When they appear together, treatment for depression can vary widely. In a new study, researchers from the German Diabetes Center (DDZ), the Research Institute of the Diabetes Academy Mergentheim (FIDAM), and the German Center for Diabetes Research (DZD) investigated how inflammation in the body relates to improvement in depression symptoms in people with T1D and T2D. The researchers combined data from three previous German randomized clinical trials that aimed to reduce elevated depressive symptoms and diabetes distress in people with type 1 or type 2 diabetes. Diabetes distress is characterized by feelings of overwhelm, frustration, guilt and worry about diabetes management and its potential complications. A total of 332 participants with T1D and 189 with T2D who had completed both a baseline and 12-month follow-up examination were included in the present study. Measures included depression using the Center for Epidemiological Studies Depression scale (CES-D), blood tests for 76 inflammatory biomarkers, and symptoms broken down into cognitive-affective (e.g., feeling hopeless), somatic (e.g., poor sleep, fatigue), and anhedonia (loss of pleasure) clusters.   After adjusting for factors like age, body mass index (BMI), diabetes duration, cholesterol, and co-existing illnesses, the researchers found that in patients with T1D, higher baseline inflammation was linked to smaller improvements in depression. Inflammation seemed to be more connected to physical/somatic symptoms in T1D patients. In those with T2D, higher baseline inflammation was linked to greater improvements in depression. For these patients, the effect was strongest for cognitive-affective and anhedonia – so, emotional and motivational – symptoms.   The researchers weren't sure what caused the difference between T1D and T2D, but they suggest it might be due to the different forms of immune activation seen in each condition. That is, autoimmune processes in type 1 and metabolic inflammation in type 2. https://newatlas.com/health-wellbeing/inflammation-diabetes-depression-treatment/ XX Parents of children diagnosed with type 1 diabetes suffer an income drop in the years following the diagnosis. The impact is more pronounced in mothers, especially mothers of children diagnosed in preschool years. And these findings come from a European study.. not the US. Previous research has shown that parents of children with type 1 diabetes are at increased risk of stress-related symptoms and may need to reduce their working hours. "In our study, we observed reduced parental work-related incomes in the years following the child's type 1 diabetes diagnosis. The drop was larger in mothers than in fathers. Since mothers earned significantly less than fathers in absolute terms, even before the child fell ill, the relative drop in mothers was 6.6% the year following diagnosis compared to 1.5% in fathers. We further note the greatest impact on work-related incomes in mothers of children diagnosed at preschool age," says Beatrice Kennedy, physician at the Endocrine and Diabetes unit at Uppsala University Hospital and Associate Professor of Medical Epidemiology at Uppsala University, who led the study. This is a huge study, builds on data from national population and health registers and the Swedish Child Diabetes Register (Swediabkids). The study includes the parents of more than 13,000 children diagnosed with type 1 diabetes in Sweden in 1993−2014, as well as more than half a million parents in the general population who have children not diagnosed with diabetes.   The researchers observed that the maternal pension-qualifying incomes (a composite outcome including work-related income and societal benefits) initially increased after the child's diagnosis. This was attributable to mothers applying for the parental care allowance from the Swedish Social Insurance Agency. The parental care allowance was intended to compensate for disease-related loss of work-related income and contribute toward disease-specific costs.   When the research team investigated long-term effects in mothers, they found that the pension-qualifying incomes gradually decreased after eight years, and had not recovered by the end of follow-up − 17 years after the children were diagnosed. https://www.news-medical.net/news/20250811/Mothers-face-greater-financial-impact-following-childe28099s-type-1-diabetes-diagnosis.aspx XX The U.S. Department of Justice has reached a settlement with Metro Nashville Public Schools after allegations that the district violated the Americans with Disabilities Act.   The parents of a student at the Ross Early Learning Center requested that the school monitor their child's glucose monitor. Investigators found the school refused to do so, despite the child's Type 1 Diabetes diagnosis.   As part of the settlement, MNPS agreed to change its policies to allow the use of these devices, ensure trained staff can monitor them throughout the entire school day and at school activities, and improve communication with parents. https://www.wsmv.com/2025/08/12/metro-nashville-public-schools-settles-allegations-it-discriminated-against-students-with-diabetes/ XX Modular Medical has unveiled Pivot, its next-generation insulin patch pump technology aimed at simplifying diabetes care. The company announced its new pump for “almost-pumpers” at the Association of Diabetes Care & Education Specialists (“ADCES”) Conference in Phoenix, Arizona this weekend. It aims for Pivot to target adults with a user-friendly, affordable design.   Modular Medical's current pump, the MODD1, won FDA clearance nearly a year ago. It features new microfluidics technology to allow for the low-cost pumping of insulin. The system 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.   The company announced recently that it validated its insulin pump cartridge line for human-use production in the U.S. Days later, it reported the first human use of the MODD1 pump.   Now, it has taken the next steps with the debut of a next-gen pump, set for FDA submission in October.   Modular Medical also gamifies diabetes care The company also said ADCES is the place where it will showcase the first playable level of its new Pivot pump gamified trainin module. Level Ex, a developer of medical games, develops the module.   Modular Medical said gamification offers a way to make medical training more effective and efficient while improving information retention. Given the complexity in pump uptake, the company hopes to provide an easy way to bring its technology to clinicians and patients.   The company expects to have training modules available at the same time as the pump's planned launch in 2026.   “Level One is free because diabetes mastery shouldn't come with a price tag,” Sam Glassenberg, CEO of Level Ex, said. “Modular Medical is breaking barriers too – bringing pump therapy to more people through smart, accessible design. Together, we intend to make diabetes management simpler and more inclusive.   “People learn best through play – and we believe they want to learn about insulin pumps the same way. In Level One, players aren't just mastering diabetes management through gameplay – they're asking to ‘play' with pumps: to explore how they work, understand their benefits, and build confidence before using them in real life. Our partnership with Modular Medical helps make that possible.” https://www.drugdeliverybusiness.com/modular-medical-unveils-next-gen-insulin-pump/ XX On Tuesday, 12 August 2025, Tandem Diabetes Care (NASDAQ:TNDM) presented at the Canaccord Genuity's 45th Annual Growth Conference, outlining strategic shifts and market focus. The company highlighted its plans for commercial transformation in the U.S. and expansion in international markets, alongside addressing competitive challenges and regulatory impacts. While optimistic about growth in Outside the U.S. (OUS) markets, Tandem is navigating a more competitive landscape domestically. We have entered into the pharmacy channel with Mobi only. And so as Mobi's been building up volume, we're getting experience and we're really learning and understanding what pharmacy offers to us. And the proof points have proved out the thesis I said earlier, which is it can really reduce that barrier for patients, is the out of pocket cost. And so we've decided to accelerate our strategy and where we were starting just with Mobi, we are now moving t slim supplies into the pharmacy channel, and that will kick into gear in the fourth quarter. So as people are looking at the cadence of sales for the remainder of the year with this reframing, many folks are seeing what looks like a a might be an outsized fourth quarter and and having trouble understanding those dynamics. We'll be adding the tSIM supplies to those contracts. We also have more coverage. We will have it in the coming weeks effective this year, so we will be increasing that 30% rate before the end of the year. And then, obviously, everyone's in the same cycle right now already negotiating and discussing their 2026 coverage. And so 30% is the floor.   We do expect to continue to grow that coverage in the coming years, and ultimately have a much broader access. Absolutely. It's an exciting technology that allows for us to have an infusion set that extends the wear time from three days to up to seven days. So we're able to use that as part of an independent infusion set, which would then be used with the t slim and with the mobi pump today. But we're also using that same technology as part of the site that's used for mobi when you use it with a tubeless cartridge. So next year, we will launch Mobi in a patch configuration.   It uses the same pump that's available today, but by using a modified cartridge, you're able to wear it as a patch pump. So one of the things we announced on the call is that we're using this extended wear technology as part of that site. So what it allows you to do is to change the portion that you wear in your skin separate from the timing of when you change the insulin cartridge. So it allows for that extended wear time, reduction of burden to the patient, which is especially important for higher volume insulin users as we expand into type two. So from here, we will launch the extended wear site next year along with we'll do a separate regulatory filing for the cartridge portion for Mobi that includes this extended wear technology as a predicate device. So that's another filing that we'll need to do, but we have the clearance today for the independent infusion set, but we'll file another five ten k for use of the extended wear technology as part of the tubeless Mobi feature. https://za.investing.com/news/transcripts/tandem-diabetes-at-canaccord-conference-strategic-shifts-and-market-focus-93CH-3834464 XX MannKind today announced a significant regulatory submission and a large financing agreement with Blackstone. The company submitted its lead inhaled insulin product for expanded FDA approval and secured $500 million in funding, it said.   First, the Danbury, Connecticut-based company announced that it submitted a supplemental Biologics License Application (sBLA) for Afrezza, its inhaled insulin product, in the pediatric population.   MannKind Director of Medical and Scientific Engagement Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, told Drug Delivery Business News at ADA 2025 that a submission was on the way for children and adolescents aged 4-17 years old. Further data shared at ADA found Afrezza both safe and effective in that age range.   Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.   The company expects a review acceptance decision early in the fourth quarter of 2025.   “The submission of our supplemental Biologics License Application (sBLA) for Afrezza in pediatric patients is a meaningful milestone for MannKind and people living with diabetes,” said Michael Castagna, CEO of MannKind Corporation.   Additional funding provides a significant boost for MannKind MannKind also announced a strategic financing agreement with funds managed by Blackstone worth up to $500 million. The financing provides MannKind with non-dilutive capital to advance its short- and long-term growth strategies.   This senior secured credit facility includes a $75 million initial term loan funded at closing. It then has a $125 million delayed draw term loan available for the next 24 months. Finally, it features an additional $300 million uncommitted delayed draw term loan available at the mutual consent of MannKind and Blackstone.   The facility bears interest at a calculated SOFR variable rate plus 4.75% and matures in August 2030.   “This strategic financing significantly increases our operating flexibility and provides us substantial access to non-dilutive capital on favorable terms, complementing our strong cash position,” said Castagna. “The funding will support the expansion of our commercial team in preparation for the anticipated launch of the pediatric indication for Afrezza, if approved, continued pipeline advancement, potential business development opportunities, and general corporate purposes. Partnering with the Blackstone team on this transaction positions us to accelerate our next phase of growth and innovation.” https://www.drugdeliverybusiness.com/mannkind-fda-submission-pediatrics-500m-blackstone/ XX   Medtronic MiniMed Abbott Instinct Sensor [Image from Medtronic Diabetes on LinkedIn] The Medtronic Diabetes business today took to social media to share an early preview of a new integrated Abbott sensor for its insulin delivery systems. Medtronic Diabetes — soon to be MiniMed after its planned separation from the medtech giant – said in the post that the new sensor specifically designed for its own systems is called “Instinct.”   “Get a sneak peek at what's coming next: the Instinct sensor,” the business unit's account wrote. “Made by Abbott, the Instinct sensor is designed exclusively for MiniMed systems. We'll share more details about the Instinct sensor when it's commercially available.”   The sensor, built on the Abbott FreeStyle Libre platform, reflects “the power of the partnership,” Abbott EVP, Diabetes Care, Chris Scoggins, told Drug Delivery Business News earlier this year.   Medtronic and Abbott — two of the largest diabetes tech companies in the world — announced a year ago that they entered into a global partnership pairing Abbott continuous glucose monitors (CGMs) with Medtronic insulin delivery systems.   The partnership aims to collaborate on a system based on Abbott's FreeStyle Libre CGMs with Medtronic's automated insulin delivery technology (the latest generation being the MiniMed 780G) and smart insulin pen systems, such as the InPen system.   Read more about Medtronic, Abbott and the rest of the diabetes tech industry in our free Diabetes Technology Special Report. Medtronic's systems previously used its own CGMs, such as the Guardian 4 and the Simplera platform, and the company intends to continue using those systems as part of a comprehensive CGM portfolio. Under the companies' agreement, the systems would be sold exclusively by Medtronic — including the Abbott CGM.   The companies brought the partnership a step further in April when Medtronic announced the submission of an interoperable pump with the Abbott sensor technology to the FDA. They plan to share more details following the expected FDA clearance, which remains pending.   Management also recently emphasized the multi-year nature of the partnership, meaning Medtronic could pair current and future pumps with other Abbott sensors in the future. That could hint at integration with the company's future dual glucose-ketone monitor, as a number of pump makers have already announced collaborations to pair their systems with the sensor once it hits the market. https://www.drugdeliverybusiness.com/medtronic-diabetes-previews-abbott-sensor-minimed/ XX Governor Glenn Youngkin joined Civica officials at the company's Petersburg manufacturing facility to announce a $3 million grant from the Commonwealth of Virginia to accelerate Civica's efforts to develop and produce affordable insulin for Americans living with diabetes.   CivicaRx Logo   "We are proud to partner with Civica in their mission to make essential medicines more accessible," said Governor Youngkin. "This investment reflects our belief in the power of public-private collaboration to improve lives and strengthen communities."   These funds will support the production of insulin aspart, a rapid-acting human insulin analog used to regulate blood sugar in adults and children with diabetes. Civica plans to produce both rapid- and long-acting insulins at its state-of-the-art manufacturing facility in Petersburg, Va., where the company now employs more than 200 skilled workers.1 Over 8 million people living with diabetes need rapid-acting and/or long-acting insulin.   The Governor also announced that he had officially proclaimed August 7 – 14 2025 'Life Sciences Week' demonstrating the Commonwealth's commitment to "accelerating the advancement of the life sciences through public-private partnerships, STEM education, workforce development, and sustained investment in research and development."   "We are grateful for the Commonwealth's support," said Ned McCoy, Civica's President and CEO. "This funding will help us move closer toward our goal of ensuring that no one has to choose between insulin and other basic needs."   Civica and Virginia officials were joined by Lynn Starr, Chief Global Advocacy Officer of Breakthrough T1D, the leading global type 1 diabetes research and advocacy organization.   "More than one million American adults live with type 1 diabetes, and many still, sadly, ration their insulin, due to the prohibitively high cost of this necessary medication," said Starr.  "Civica's work will help to make insulin more affordable for people across the country."   Breakthrough T1D is among more than two dozen organizations and philanthropists, along with the states of Virginia and California, that have partnered with Civica to support the development of affordable insulins.   Civica's insulin initiative aims to provide patients with predictable, transparent pricing — no more than $30 per vial or $55 for a box of five pens — regardless of insurance status.   About Civica Civica is a nonprofit pharmaceutical company established to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients.   Media Contact: Liz Power liz.power@civicarx.org +1 860 501 3849 https://cbs4indy.com/business/press-releases/cision/20250807NY46213/governor-glenn-youngkin-announces-3-million-grant-to-support-civicas-affordable-insulin-programs/ XX If you or someone you love is living with diabetes, you already know the fight isn't just medical—it's financial, too. Between daily supplies, doctor visits, and long-term care, the cost of managing type 1 or type 2 diabetes can be overwhelming. Add college or trade school into the equation, and suddenly staying healthy competes with building a future. That's where scholarships for students with diabetes—like Beyond Scholars and others listed here—step in.   Whether you're headed to a university, a two-year college, or a hands-on trade program, these opportunities were created to ease the load.   Scholarships for students with diabetes Beyond Scholars (from Beyond Type 1): $10,000 for recently graduated high school seniors with type 1 diabetes or type 2 diabetes entering college or trade school. This is one of the largest needs-based diabetes scholarships in the United States. This year, awardees will also receive 6 months of wellness coaching through Risely Health.   Applications open: July 25, 2025 Deadline: August 29, 2025 Winners announced: October 2025 https://beyondtype1.org/beyond-scholars-diabetes-scholarships-college-trade-school/ XX Nick Jonas and Kyle Rudolph are using their platforms for a good cause.   On Tuesday, Aug. 12, the singer and the former NFL tight end (via his professional fundraising platform Alltroo) announced they're teaming up to launch a rally featuring a fan-coveted prize: a custom 2025 Volkswagen ID. Buzz electric bus that the Jonas Brothers have brought along for their 20th anniversary tour.   “Ten years ago, we hit the road with a goal to change what it means to live with diabetes. Since then, Beyond Type 1 has grown into the world's largest digital diabetes community, offering the tools, education, and peer support needed to not only survive but thrive with diabetes,” Jonas, who co-founded Beyond Type 1 (a nonprofit that advocates for those living with diabetes), says in a statement.     “We've challenged stigma, built community, provided life-saving resources, and collectively driven global innovation toward prevention and cure. This milestone is a moment to rally even more support for our mission, and partnering with Alltroo helps us do that in a powerful, engaging way.”   Related Stories Nick Jonas on Managing His Diabetes: 'The Mental and Emotional Health Aspect Is Really Important' nick jonas Nick Jonas Says He Was Diagnosed with Diabetes After Joe Told Their Parents: 'Something's Really Wrong' Joe Jonas and Nick Jonas attend the amfAR Cannes Gala 30th edition at Hotel du Cap-Eden-Roc on May 23, 2024 For Rudolph, the campaign is about "celebrating Beyond Type 1's incredible work over the past decade, and standing behind their vision of a world where everyone with diabetes — or at risk of it — has access to the knowledge, care and support needed for early diagnosis and lifelong health."   While the rally is live on Alltroo.com, fans can also scan QR codes available at all 36 Jonas Brothers concert stops to enter for a chance to win the electric bus. (A winner will be selected on November 14, which is World Diabetes Day.)   Jonas, 32, has long been open about his Type 1 diabetes diagnosis at 13 years old. "I had this kind of wrench thrown into things when I was diagnosed and it took a while to figure out how to count carbs to properly dose for insulin and what things would affect me in different ways," he previously told PEOPLE.   "When I was first diagnosed, I was sitting in the hospital and was scared to death, honestly, while I was learning about how to manage this new thing I was dealing with," Jonas recalled. "It would have been amazing to have someone to look at at that time to say, oh, this is a person living with it and they're following their dreams. They're doing what they want to do with their lives and not letting it slow them down."           https://people.com/nick-jonas-kyle-rudolph-launch-fan-rally-diabetes-awareness-11788684

On July 31, 2025, Eli Lilly and Company announced topline data from the SURPASS‑CVOT trial comparing tirzepatide (Mounjaro) to dulaglutide (Trulicity) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD). According to the data, tirzepatide met the primary non‑inferiority endpoint for 3-point major adverse cardiovascular events (MACE) (hazard ratio [HR], 0.92; 95.3% CI, 0.83 to 1.01), while also showing additional benefits in A1C, weight reduction, renal preservation, and a 16% reduction in all‑cause mortality (HR, 0.84; 95.0% CI, 0.75 to 0.94). In the latest episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, unpacked the top-line results of the SURPASS-CVOT trial. Eli Lilly and Company owns both drugs, which belong to the incretin class, but tirzepatide is a dual GIP/GLP-1 receptor agonist, while dulaglutide is a GLP-1 RA. The trial included over 13,000 adults with type 2 diabetes and either established cardiovascular disease or at high risk. During a median follow-up of 4.5 years, the primary endpoint, which was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, was reduced by 8% in the tirzepatide group relative to dulaglutide. However, the result did not reach statistical superiority due to the confidence interval crossing unity. Isaacs and Bellini also highlighted significantly greater A1c (-1.73% vs -0.9%) and weight loss (12% vs 4.95%) with tirzepatide. Additional prespecified analyses comparing data with the placebo-controlled REWIND trial suggest tirzepatide could offer up to 28% MACE and 39% mortality risk reduction compared to theoretical placebo—findings that hint at broader cardiometabolic benefit. Before concluding, hosts speculated about the potential subgroup analyses of interest for the trial, including heart failure and renal outcomes, as well as a brief discussion around Eli Lilly and Company's intent to submit a regulatory application for a cardiovascular indication before the close of 2025. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Eli Lilly and Company. Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease. July 31, 2025. Accessed July 31, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: loads of news from American Diabetes Association Scientific Sessions, GLP1 for T1D, Tech updates, diabetes in space, 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 Top story – looking back at The American Diabetes Association Scientific Sessions conference. I won't recap everything here – but I'll link up to a few more comprehensive article. Here's just a taste! XX A single infusion of a new stem cell-based treatment helped 10 out of 12 people with severe type 1 diabetes stop using insulin, researchers report. The treatment, called zimislecel, was made by Vertex Pharmaceuticals. It's an infusion of lab-grown islet cells. A year after getting the therapy, 10 patients no longer needed insulin shots. The other two were able to reduce how much insulin they needed.  The treatment requires patients to take immunosuppressive drugs, which may raise the risk of infections or cancer in the long run, experts said. https://www.usnews.com/news/health-news/articles/2025-06-24/stem-cell-treatment-may-free-some-with-type-1-diabetes-from-insulin XX New study shows inhaled insulin is safe and effective for children with type 1 diabetes. This is Mannkind's Afrezza, which takes the place of rapid-acting mealtime insulin. Findings indicate that inhaled insulin delivers glycemic control comparable to injected rapid-acting insulin. Inhaled insulin was also associated with less weight gain and slightly higher patient and parent preference scores. These findings add to outcomes shared from INHALE 1 late last year. Based on the findings of the inhaled insulin study, MannKind looks to seek FDA approval to expand Afrezza's indication to children. The company also aims to evaluate inhaled insulin at diagnosis and in automated insulin delivery systems in additional studies. https://www.drugdeliverybusiness.com/study-mannkind-inhaled-insulin-safe-effective-children/ XX Positive outcomes in two different studies looking at GLP 1 medications for type 1. Semaglutide – brand name Ozempic or Wegovy - reduced glucose levels and weight among patients with type 1 diabetes and obesity. 26-week, double-blind trial of 72 adults, those taking Ozempic spent More than 70% time spent in sensor glucose range (70-180 mg/dL) Less than 4% time spent in hypoglycemia (

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, recorded during the 85th Scientific Sessions of the American Diabetes Association (ADA 2025) in Chicago, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, speak with Rachael Sood, RN, MSN, APRN, NP, CDCES, founder of The Diabetes Collective, about modern approaches to diabetes care, patient engagement, and the role of social media in education and advocacy. The discussion highlights Sood's innovative use of social media to make diabetes education accessible and engaging. Known for creative and widely shared content—such as her wedding-themed video announcing the Dexcom G7 and Omnipod 5 integration—Sood shares how spontaneous, relatable messaging can improve awareness and patient connection. Her content spans emerging therapeutics like GLP-1 receptor agonists, type 1 diabetes staging and screening, and technology updates such as ketone monitoring and CGM integration. Sood reflects on the emotional impact of recent ADA presentations, including advances in islet cell therapy and the evolving treatment landscape for both type 1 and type 2 diabetes. She emphasizes the importance of healthcare providers offering clear, empathetic, and tailored care, recounting a patient case where basic interventions—CGM use, education, and therapeutic escalation—had a transformative effect after years of clinical inertia. The episode underscores the value of clinician-led care, continuity, and communication, particularly in independent practices. Sood also points to the importance of collaborative energy within the diabetes community, noting the power of partnerships among healthcare professionals, patients, and advocacy groups to drive progress. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Sanofi, and others. Sood has no relevant disclosures to report.

In this episode of Diabetes Dialogue, recorded live at the 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Jay Shubrook, DO, and Conan Tu, MD, to explore the mission and momentum of the American College of Diabetology. The conversation centers on addressing the national shortage of diabetes specialists. Shubrook, a primary care diabetologist and founding figure in diabetology training, details the evolution of fellowship programs dating back to 2004, with the current infrastructure supporting 11 programs and plans for further expansion. Tu, an internist from New York, shares his personal journey into diabetology, emphasizing the increasing demand for diabetes-focused care in primary settings and the transformative impact of timely, expert-level interventions. The guests outline how the American College of Diabetology is building a standardized, certified workforce through board certification, with an emphasis on team-based care. The College is also actively expanding to include pharmacists, nurse practitioners, and other healthcare professionals in its educational and certification efforts, helping to equip interdisciplinary teams to manage diabetes more effectively. Additional discussion highlights include the importance of continuity of care—particularly during the transition from pediatric to adult diabetes services—the integration of cardiometabolic risk management, and the critical need for scalable models of care. The speakers advocate for diabetologists to serve not only as direct providers but as in-house experts, mentors, and system-level educators capable of elevating care across large networks. Learn more about the American College of Diabetology. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Sanofi, and others. Relevant dislcures for Tu include AstraZeneca, Eli Lilly and Company, and Optum. Relevant disclosures for Shubrook include Abbott, AstraZeneca, Bayer, Eli Lilly and Company, and Novo Nordisk.

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, speak with John Buse, MD, PhD, of the University of North Carolina School of Medicine, about the treatment phase of the CATALYST trial. Findings from the phase 4 CATALYST trial suggest that mifepristone (Korlym), a glucocorticoid receptor antagonist, significantly improves glycemic control, reduces body weight, and lowers waist circumference in patients with hypercortisolism and difficult-to-control type 2 diabetes—offering a promising therapeutic option for a population with limited treatment success. The two-part, multicenter study enrolled 1055 adults with type 2 diabetes and HbA1c >7.5% despite optimized therapy. In part 1, participants underwent dexamethasone suppression testing to identify hypercortisolism, defined by post-test cortisol levels >1.8 µg/dL and dexamethasone >140 ng/dL. Results revealed a 24% prevalence of hypercortisolism in this population (95% CI, 21.4–26.7%). Part 2 randomized 136 patients with confirmed hypercortisolism in a 2:1 ratio to receive mifepristone or placebo for 24 weeks. The primary endpoint was change in HbA1c. Mifepristone treatment led to a least squares mean HbA1c reduction of 1.3 percentage points compared to placebo (95% CI, –1.81 to –0.83; P < .001). Secondary endpoints also favored mifepristone: body weight decreased by 5.12 kg (95% CI, –8.20 to –2.03), and waist circumference dropped by 5.1 cm (95% CI, –8.23 to –1.99) relative to placebo. Despite its efficacy, 49% of mifepristone-treated patients discontinued therapy, compared to 18% on placebo. Adverse events included hypokalemia, fatigue, nausea, vomiting, and elevated blood pressure, consistent with the drug's known safety profile. During the episode, which was recorded during the 85th Scientific Sessions of the American Diabetes Association (ADA 2025), Buse provides hosts with a deep dive into the background of the trial, prevalence of hypercortisolism in difficult-to-control type 2 diabetes, and the historic relevance of the CATALYST results. Buse also discusses how the trial offers insight into dosing approaches with mifepristone and advocates for broader cortisol screening in patients with complex type 2 diabetes—suggesting that ADA Standards of Care should reflect these findings. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Relevant disclosures for Buse include Altimmune, AstraZeneca, Boehringer-Ingelheim, CeQur, Corcept Therapeutics, Eli Lilly, embecta, Moderna, Novo Nordisk, Tandem, Vertex, and others.

In this special episode recorded at 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, take a deep dive into the REDEFINE 1 and REDEFINE 2 trials with trial investigators W. Timothy Garvey, MD, of University of Alabama at Birmingham, and Melanie Davies, MD, of the University of Leicester. REDEFINE 1 was a 68-week, phase 3a trial enrolling over 3400 adults without diabetes but with obesity or overweight and at least one comorbidity. Participants received once-weekly CagriSema, semaglutide alone, cagrilintide alone, or placebo alongside lifestyle intervention. Key outcome: CagriSema led to a mean weight loss of 20.4%, vs 3.0% with placebo. Over 50% of participants on CagriSema reached a non-obese BMI. Gastrointestinal side effects were common (80%), but mostly mild to moderate. REDEFINE 2 enrolled 1206 adults with type 2 diabetes and overweight or obesity, randomized to CagriSema or placebo for 68 weeks. Key outcome: CagriSema led to 13.7% mean weight loss, vs 3.4% with placebo. 73.5% achieved an HbA1c ≤6.5% vs 15.9% on placebo. Significant improvements were seen across all weight loss and glycemic endpoints. The speakers also highlight the agent's favorable side effect profile, flexibility in real-world dosing, and benefits in body composition and physical function. Garvey emphasizes the shift toward complication-centric obesity care, underscoring the need for clinician-guided treatment beyond online prescription models. The conversation closes with a look ahead to REDEFINE 3—a cardiovascular outcomes trial including patients with and without diabetes—and other ongoing studies in the REDEFINE and REIMAGINE trial programs. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Relevant disclosures for Garvey include Boehringer-Ingelheim, Novo Nordisk, Eli Lilly and Company, Merck & Co., Inc., Alnylam Pharmaceuticals, Inc., Fractyl Health, Inc., Inogen, Epitomee, Pfizer Inc., and Neurovalens. Relevant disclosures for Davies include Abbie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GSK, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, and Zealand Pharma. References: Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502081 Davies MJ, Bajaj HS, Broholm C. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502082

In this special episode recorded at 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, welcome Kevin Sayer, chief executive officer of Dexcom, for a candid conversation about the evolving landscape of continuous glucose monitoring (CGM). From Dexcom's origins to the latest updates on G7 and the emerging Stelo app, the discussion traces the company's journey and innovation roadmap. Sayer reflects on how sharing real-time glucose data transformed the diabetes management experience—making life safer not just for children but also for adults living independently, caregivers, and entire family networks. Dexcom's emphasis on data transparency has laid the groundwork for a broader shift toward individualized care, especially for those with type 2 diabetes. The episode dives into Dexcom's growing footprint in type 2 diabetes management, with expanded coverage across the nation's three largest pharmacy benefit managers. Sayer emphasizes that CGM is not just about preventing hypoglycemia in insulin users anymore—it's a behavioral and educational tool. Patients can now “see” the impact of food choices, physical activity, and medication adherence in real time, prompting lifestyle changes that might otherwise take years of trial-and-error clinical encounters. The hosts also explore the integration of AI-powered features like food recognition, enhancements in the Stelo app for wellness tracking, and the implications of new CGM algorithms as G7 expands to 15-day wear. Sayer addresses the unique needs of people with and without diabetes and the regulatory constraints in tailoring CGM algorithms to specific use cases. In a lighter moment, Sayer shares his enthusiasm for Dexcom's public-facing campaigns, including recent collaborations with Lance Bass and Nick Jonas as well as the company's network of “Dexcom Warriors.” Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, are joined by Roy Beck, MD, PhD, executive director of the Jaeb Center for Health Research, to discuss the INHALE-3 trial, an adult study evaluating technosphere inhaled insulin (Afrezza) in comparison to standard diabetes therapies, including automated insulin delivery (AID) systems. Beck outlined his center's transition from ophthalmology-focused research to becoming a key player in diabetes trials over the last 25 years, particularly in technology-driven therapies. The conversation explores inhaled insulin's pharmacokinetic profile—its rapid onset and short duration, which more closely mimics physiologic insulin responses than injected rapid-acting analogs. The INHALE-3 trial randomized adults with type 1 diabetes (T1D), including nearly 50% who were on AID systems, to either continue their current regimen or switch to once-daily insulin degludec plus Afrezza for meals and corrections. Surprisingly, Beck highlighted participants willing to suspend AID use to try the inhaled approach, allowing for a head-to-head comparison. The study met its primary non-inferiority endpoint for HbA1c, with outcomes from Afrezza plus basal insulin comparable to those achieved with AID and multiple daily injections. However, Beck emphasized the heterogeneity in response. Approximately 30% of participants switching to Afrezza achieved notably better glycemic control (including greater reductions in HbA1c and less time >250 mg/dL), while a similar proportion performed worse, largely depending on their engagement and dosing frequency. CGM use was required in the study, enabling patients to re-dose Afrezza postprandially as needed, a key factor in those who succeeded. Beck also indicated that overnight glycemic control remained a challenge. While Afrezza performed well during daytime periods, AID systems outperformed it overnight—an expected finding given AID's strength in basal modulation. Weight gain was also lower in the Afrezza group, offering an additional potential advantage. Hosts discussed real-world use cases combining AID with Afrezza, with Beck sharing his son's personal success using Afrezza alongside Tandem Diabetes' Control-IQ in sleep mode, a workaround to prevent algorithmic overlap. He noted future integration could be more seamless with upcoming Bluetooth-enabled Afrezza inhalers or AID systems capable of receiving inhalation data. Safety data showed bronchospasm was rare in the trial, with no confirmed cases attributable to Afrezza. Cough was the most common side effect, generally mild and transient, while active asthma and smoking remained contraindications. Isaacs and Bellini highlighted Afrezza's potential as an underutilized but powerful option in the diabetes toolkit, particularly for patients seeking alternatives to injections or pumps, or looking for greater control over postprandial excursions. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Chapters 00:00:01 Introduction and Background of Dr. Roy Beck 00:02:16 Overview of Inhaled Insulin 00:06:31 INHALE-1 Pediatric Study 00:07:21 INHALE-3 Adult Study 00:11:18 Study Results and Participant Outcomes 00:19:57 Challenges and Future Directions 00:26:44 Side Effects and Safety Concerns 00:31:09 Conclusion and Final Thoughts

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, co-hosts Diana Isaacs, PharmD, BCPS, BC-ADM, CDCES, FADCES, and Natalie Bellini, DNP, FNP-BC, provide a comprehensive review of the 2025 American Association of Clinical Endocrinology (AACE) Annual Meeting held in Orlando, Florida. The episode captures notable sessions, emerging clinical insights, and advances in diabetes care and endocrinology presented during the conference. The discussion opens with reflections on keynote lectures, including a plenary led by Daniel Drucker, MD, on incretin physiology and the clinical evolution of GLP-1 receptor agonists. Isaacs highlights the importance of his translational research and addresses the implications of safety concerns such as pancreatitis and thyroid cancer. Both hosts express admiration for Drucker's role in shaping the field of incretin-based therapies. Another highlight includes the plenary delivered by Anne L. Peters, MD, which emphasized health equity and expanding access to diabetes technology in underserved populations. Isaacs discusses Peters' innovative use of pharmacists in insulin pump clinics and her longstanding contributions to ADA standards of care. Bellini commends Peters' dual impact in both affluent and marginalized communities. The hosts also describe their participation in a hands-on diabetes technology workshop, where attendees rotated through device-specific stations including insulin pumps, CGMs, inhaled insulin, and smart pens. This workshop was part of a broader effort to launch a diabetes technology certification program, with both in-person and online components scheduled for release in summer 2025. Clinical trial updates included coverage of the CONTROL-IQ Plus RCT in type 2 diabetes, studies on weekly insulin formulations, CGM use in inpatient settings, and the Inhale-3 trial on inhaled insulin efficacy. Discussions also touched on advancements in over-the-counter CGMs, data interpretation challenges in individuals without diabetes, and the proposed shift toward using time-in-normal glucose range (TING) metrics to assess glycemic control. The episode concludes with enthusiasm for the future of patient-centered technology and anticipation for the AACE 2026 meeting in Las Vegas. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down with Steven Russell, MD, PhD, Chief Medical Officer at Beta Bionics, to discuss the latest real-world outcomes from the iLet Bionic Pancreas—an autonomous insulin delivery (AID) system cleared by the US Food and Drug Administration (FDA) in 2023. Russell outlines the iLet's fully automated design, which sets it apart from conventional AID systems by requiring no manual settings, carb ratios, or correction factors. The system determines 100% of insulin dosing, adapting continuously to glycemic trends without relying on user engagement. This autonomy makes the iLet particularly effective for individuals with suboptimal diabetes self-management or limited access to endocrinology care. New real-world data, covering 3,300 users from the first year of commercial rollout, reveal a mean baseline A1c of 8.5%—higher than the 7.8% in the pivotal trial and reflective of the broader U.S. type 1 diabetes (T1D) population. The iLet reduced glucose management indicator to 7.3%, yielding an average A1c reduction of 1.2%, more than double that seen in the pivotal study. Outcomes were most pronounced among those with severe hyperglycemia: users starting with A1c >14% saw average reductions of 7%, with low rates of diabetic ketoacidosis (DKA) and minimal increases in hypoglycemia (median time

Video Version Only on HCPLive! Key Episode Timestamps 00:00:05 Introduction and Background of Luna Diabetes 00:02:27 Overview of Luna and Its Unique Features 00:04:58 Details of Luna's Functionality and User Experience 00:14:24 Clinical Trials and Feasibility Study Results 00:20:49 Potential Applications and Future Directions 00:24:54 Conclusion and Final Thoughts In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down with John Sjölund and Jon Brilliant, co-founders of Luna Diabetes, to explore their novel approach to automated insulin delivery (AID) designed specifically for individuals with diabetes using insulin pens. The discussion introduces Luna, a small, wearable overnight patch pump that delivers automated insulin microdoses during sleep, addressing one of the most persistent gaps in diabetes care: nighttime glucose variability. Unlike traditional AID systems that require full-day pump use, Luna is built for simplicity and intermittent use. It integrates with any continuous glucose monitor (CGM), requires no input on insulin type, and adapts automatically without user-programmed settings. The system supplements a patient's existing basal insulin, providing algorithm-driven microdoses of rapid-acting insulin at night. The device operates with minimal user interaction—patients fill the pod with up to 10 units of insulin, apply it before bed, and remove it in the morning. Preliminary data from Luna's feasibility study showed promising results: an average 10% increase in time-in-range and a 15% reduction in time spent above 250 mg/dL, without increased hypoglycemia. The ongoing pivotal trial, enrolling 120 participants with type 1 diabetes (T1D), aims to further evaluate safety, efficacy, and patient-reported outcomes, particularly sleep quality, across 13 weeks.  Sjölund and Brilliant emphasized Luna isn't designed to match the full clinical performance of traditional AID systems, but rather to expand access by lowering barriers—providing improved overnight control and reducing cognitive and emotional diabetes burden, especially for those who prefer to avoid pumps. Isaacs and Bellini highlighted Luna's potential not only for people with type 1 diabetes but also for those with type 2 diabetes (T2D), particularly in conjunction with GLP-1 therapies or for patients early in their insulin journey. Luna's no-training-required model could also enable broader adoption in primary care settings, where most diabetes management occurs. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Video Version Only on HCPLive!  In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new key updates on cotntinous glucose monitoring (CGM) systems for diabetes, incuding the Dexcom G7, Libre App, and Medtronic Simplera Sync. Dexcom G7 15 Day CGM On April 10, 2025, the FDA granted clearance to the Dexcom G7 15-day continuous glucose monitoring (CGM) system for individuals aged 18 years and older with diabetes. The G7 CGM now boasts the longest-lasting CGM system with 15.5 days of wear and best-in-class accuracy with a mean absolute relative difference (MARD) of 8.0%. Isaacs and Bellini discussed the sensor life of the G7 CGM, with Dexcom announcing only 73.9% of sensors lasted the full 15 days. When using the product per package labeling, approximately 26% of sensors may not last for the full 15 days. Abbott Libre App With the launch of the new Libre app, Abbott is replacing the Libre 2 and 3 apps with a new all-in-one app that works with all Libre sensors. With the upcoming discontinuation of Libre 2 and 3 (non-Plus) sensors in the US by September 2025, intermittent scanning will be phased out, improving data continuity and aligning with American Diabetes Association (ADA) recommendations. They also highlight Libre's new integration with Glooko, allowing direct data syncing via Bluetooth from the app. This streamlines clinical workflows, supports EHR integration, and includes features like voice-activated carb logging, reducing both patient and provider burden. Medtronic Simplera Sync On April 18, 2025, the FDA approved Medtronic's Simplera Sync sensor for use with its MiniMed 780G insulin delivery system, expanding CGM options for users. The new all-in-one, fingerstick-free sensor offers simplified insertion and enhanced user flexibility while maintaining compatibility with the system's Meal Detection™ technology and adaptive insulin algorithm. A limited US launch is planned for fall 2025. Isaacs and Bellini noted this long-awaited update could improve access and uptake in the US., especially for newly diagnosed patients, thanks to easier usability and compatibility with Medtronic's strong insulin delivery algorithm. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:30 Dexcom G7 15-Day Sensor Approval 00:02:11 Challenges with Sensor Lifespan 00:06:00 Education and Replacement Process 00:09:27 Accuracy and FDA Approval Details 00:11:37 Libre's New Mobile App 00:16:55 Integration with Gluco 00:19:41 Medtronic's Simplera Sync Approval 00:23:03 Future Collaborations and Algorithms 00:28:05 Final Thoughts and Wrap-Up

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide's impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment. ESSENCE Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial. In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023. At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the newly published findings from the CATALYST trial, a prospective, observational study establishing the prevalence of hypercortisolism among individuals with difficult-to-control type 2 diabetes (T2D). CATALYST enrolled 1057 adults with T2D and suboptimal glycemic control (HbA1c, 7.5–11.5%) despite treatment with ≥2 glucose-lowering agents. All participants underwent a 1-mg overnight dexamethasone suppression test (DST), and common confounders were excluded. Hypercortisolism—defined as a post-DST cortisol level >1.8 µg/dL—was identified in 23.8% of participants, with even higher rates among those with cardiac disease (33.3%) or on ≥3 antihypertensives (36.6%). Adrenal imaging revealed abnormalities in about one-third of affected individuals. Isaacs and Bellini emphasized how striking it is that such a high proportion of patients met criteria for hypercortisolism, a condition historically considered rare. The trial challenges that perception, revealing that clinical features like persistent hyperglycemia and hypertension—despite optimized therapy—could reflect underlying endocrine dysfunction. They noted that neither A1c nor body mass index (BMI) alone predicted elevated cortisol, although medication intensity and comorbid conditions did. The conversation explored how the recognition of hypercortisolism could alter clinical management. Future studies will assess whether targeted treatments—such as cortisol-lowering pharmacotherapy, including mifepristone (Korlym), or adrenal surgery—can reduce medication burden, improve glycemic control, and lower cardiovascular risk. Isaacs and Bellini pointed out that many patients with hypercortisolism present without the classic phenotype, underscoring the importance of broader screening criteria. Looking ahead, they called for greater awareness among clinicians to consider screening in patients on intensive diabetes and blood pressure regimens who still fail to reach therapeutic goals. Identifying and treating hypercortisolism could open a new pathway to improving outcomes in this population. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:01 Catalyst Trial Overview and Introduction 00:01:37 Patient Criteria and Initial Findings 00:04:18 Implications and Next Steps 00:05:23 Adrenal Imaging and Cardiac Disorders 00:07:22 Clinical Implications and Future Research 00:09:13 Demographic Differences and Future Directions

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the top-line results from the ACHIEVE-1 trial evaluating orforglipron—an investigational, once-daily oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Eli Lilly—for adults with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Isaacs and Bellini emphasized the clinical significance of orforglipron's Phase 3 data in the ACHIEVE-1 trial, which demonstrated substantial reductions in A1c (1.3–1.6%) from a baseline of 8.0% and notable weight loss averaging 16 pounds (7.9%) at the highest dose over 40 weeks. Impressively, more than 65% of participants achieved an A1c below 6.5%, meeting the American Diabetes Association (ADA)'s target for diabetes control. The hosts highlighted the convenience advantage of orforglipron compared to oral semaglutide, which has strict dosing requirements. Oral orforglipron can be taken without food or water restrictions, potentially increasing adherence and reducing treatment burden. They also noted the drug's favorable safety profile, with gastrointestinal side effects similar in type and incidence to existing GLP-1 RAs, and no hepatic safety signals observed in the trial. Beyond glycemic control, Isaacs and Bellini discussed the broader implications for obesity treatment, pointing to the drug's potential utility in weight management, pending regulatory submission. They explored the possibility of using injectable GLP-1 RAs for initial weight loss followed by oral maintenance with orforglipron—potentially lowering costs and improving access. The conversation touched on the upcoming ACHIEVE trial series, which will explore orforglipron in head-to-head comparisons with other agents, its use in insulin-treated T2D, and future indications including cardiovascular risk and kidney disease. While optimistic, the hosts stressed the need for cardiovascular outcomes data to confirm orforglipron's safety and potential benefits in this domain. If confirmed, they suggested orforglipron could become a cornerstone oral therapy for T2D and obesity. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:01 Discussion on OR for GLP-1 Receptor Agonist 00:02:13 Potential Impact and Patient Preferences 00:03:59 Safety and Market Potential 00:05:13 Cost and Transition Options 00:06:32 Future Trials and Side Effects 00:08:55 Cardiovascular Outcome Data and Conclusion

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, are joined by Rifka Schulman-Rosenbaum, MD, director of inpatient diabetes at Long Island Jewish Medical Center and co-author of Establishing Screening Programs for Pre-symptomatic Type 1 Diabetes: Practical Guidance for Diabetes Care Providers, a new paper in the Journal of Clinical Endocrinology and Metabolism. With Bellini as a co-author of the piece, experts explored the increasing clinical and operational momentum behind screening for pre-symptomatic type 1 diabetes (T1D) and what it takes to implement effective programs in real-world settings. The conversation centers on the rationale and logistics behind identifying individuals in stages 1 and 2 of T1D—autoimmune stages characterized by multiple islet autoantibodies before clinical onset. With the availability of teplizumab (Tzield), a disease-modifying therapy shown to delay progression to stage 3 of T1D, the importance of early detection and standardized screening protocols has become more urgent. Schulman-Rosenbaum outlined how her work on the JDRF Breakthrough T1D initiative led to the development of actionable guidance aimed at frontline diabetes care providers. She highlights barriers to implementation—such as limited provider awareness of T1D staging and screening protocols—and details her institution's ongoing efforts to educate primary care clinicians and endocrinologists, including distributing screening handouts and creating streamlined workflows using dot phrases and dedicated follow-up slots. The discussion emphasizes targeted screening for high-risk groups, such as first- and second-degree relatives of individuals with T1D and patients with autoimmune diseases like Hashimoto's or celiac. Schulman-Rosenbaum emphasized the opportunity for endocrinologists to screen these patients directly during routine care and the utility of a centralized handout to guide test ordering and family engagement. Drawing from their paper, experts outlined practical steps for launching autoantibody screening programs: nominating a program champion, forming an implementation team, and embedding screening into existing clinical systems. Experts stressed the importance of using appropriate ICD-10 codes for insurance coverage and referenced a diagnostic coding table in their publication. Schulman-Rosenbaum also addressed the widespread issue of misdiagnosis, particularly in adults mistakenly classified as having type 2 diabetes, and outlines best practices for using antibody and C-peptide testing to refine diagnosis. She detailed her hospital's approach to inpatient screening, noting an increased use of autoantibody testing and follow-up coordination for patients with suspected T1D or latent autoimmune diabetes in adults (LADA). Finally, the episode highlighted how to monitor individuals who test positive for a single antibody or exhibit mild dysglycemia, noting that many fall outside established risk categories. Experts called for more research in this area and advocate for individualized monitoring strategies based on clinical risk, family history, and emerging glucose patterns—often using continuous glucose monitoring (CGM) data. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:00 Introduction 00:02:18 Inspiration Behind the Paper 00:04:12 Challenges in Implementing T1D Screening 00:07:32 Educating Providers and Overcoming Barriers 00:09:32 Addressing Misdiagnosis of Diabetes 00:12:01 Inpatient Screening Practices 00:16:13 Support and Resources for Patients with Positive Antibodies 00:20:01 Conclusion and Final Thoughts

It's finally Long Beach Grand Prix week, and Conor Daly has a brand new livery just in time for the famed event. He joins co-host Chase Holden to chat about the Mannkind-sponsored Juncos Hollinger 76 entry he'll be piloting this weekend, as well as what listeners should expect to see when IndyCar hits the track. The race has been lengthened to 90 laps this season, which Conor explains will unlock new opportunities for strategy. Drivers and teams will also be dealing with a similar tire selection to the St. Pete season opener, which showed favorable results. The guys make their podium picks for the race and chat about the other latest news around the IndyCar paddock.In celebration of the 40th anniversary of his 1985 Indianapolis 500 victory, IndyCar legend Danny Sullivan joins the program. He fills listeners in on his journey from Louisville, Kentucky to the famous Jim Russell Driving School in England, which sent him on the path of formula racing. After a brief stint in Formula One in 1983, Danny would return Stateside and take his place in the CART paddock. In 1985, Danny completed the famous “spin and win” at the Brickyard, which has become one of the most iconic moments in the history of the race. He chats with Conor and Chase about what life was like on the grid back then and what the victory did for his life and career.

Tonight, on a Monday night edition of Trackside with Curt Cavin and Kevin Lee, they talk about Robert Wickens returning to the driver’s seat to compete in the IMSA WeatherTech Sports Car race this weekend at Long Beach. They later look forward and preview this weekend’s Acura Grand Prix of Long Beach and talk about who looks good and not. They also talk a little about tonight’s NCAA Men’s Basketball Tournament championship game between Florida and Houston. Later, they talk about some new looks for this weekend's race, with Conor Daly driving a new MannKind livery, Marcus Armstrong with Root Insurance, and Nolan Siegel with Onsemi. Later in the first hour of the show, they talk about the reopening of the Indianapolis Motor Speedway Museum and talk more about Jay Frye going to Rahal Letterman Lanigan Racing as their team president. They also talk about NASCAR competing at Darlington Raceway yesterday with their throwback weekend, and they talk about if IndyCar would ever do a throwback weekend. To wrap up wrap up the first hour of the show, they talk about the passing of Shigeaki Hattori over the weekend after a car accident in North Carolina. They also talk about the passings of Jersey Johnny Cimasko and Maurice Kessler. To start the second hour of the show, they talk about Curt’s official induction in the Indiana Sportswriters and Sportscasters Association Hall of Fame. They later talk about the update on the newest IndyCar chassis coming in 2027 or 2028. They also talk about Tony Kanaan getting some testing laps in case if Kyle Larson has to skip the Indianapolis 500 for rain. Later in the second hour of the program, they answer fan questions from X, such as if there could ever be a return to Japan. They also talk about parking for the Indy 500 which has sold out. Then to wrap up another addition of the show, Kevin talks with Jackson Lee as he competed at Mid-Ohio for the World Racing League as he breaks down his weekend with crazy weather conditions and being teammates with Brian Till. See omnystudio.com/listener for privacy information.

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin. A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing. HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, There were no differences between groups or concerns in other safety measures, including hypoglycemia. https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex   XX Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health. Stelo users will start seeing the features this week. The AI is modeled after Google Cloud's Vertex AI and Gemini models. We'll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare. BTW this press release is the first time I've seen what seems to be a new slogan for Dexcom – Discover What You're Made Of. https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing XX Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention.   XX Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company. The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.   Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges. This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030. https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html     XX Can we add treating sleep apnea to the list of applications for terzepatide? That's the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea. Eli Lilly said there was nearly a 20% reduction in weight among those in the trials. The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year. https://www.aol.com/popular-weight-loss-drug-could-131507702.html   XX Health Canada okays Tandem's tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors. Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7's 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4. Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025.   To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca. https://www.businesswire.com/news/home/20241210731189/en/Tandem-tslim-X2-Insulin-Pump-Now-Compatible-with-Dexcom-G7-CGM-in-Canada XX A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps. The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision. Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps. In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million.   A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe's Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea.   The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet's trade secrets.   Insulet CEO Jim Hollingshead said the company is “extremely pleased with the jury's verdict.” EOFlow did not immediately respond to a request for comment. https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/ XX A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds. Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions. Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care. https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes XX New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable. In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them. We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support. For more information, please visit: https://lnkd.in/gTDhnDc4 XX I'm also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2. https://www.medscape.com/viewarticle/icymi-top-10-diabetes-endocrinology-stories-2024-2024a1000n6u?&icd=login_success_email_match_fpf XX That's it for the last In the News of 2024! Don't miss out episode next week with a look ahead to what we're watching in 2025. I'm SS I'll see you back here soon…

Today we are discussing Afrezza with Michael Castagna, CEO of MannKind. Screen It Like You Mean It Eversense CGM Learn about the Medtronic Champions This BetterHelp link saves 10% on your first month of therapy Try delicious AG1 - Drink AG1.com/Juicebox I Have Vision Use code JUICEBOX to save 30% at Cozy Earth  Get Gvoke HypoPen CONTOUR NextGen smart meter and CONTOUR DIABETES app Learn about the Dexcom G6 and G7 CGM Go tubeless with Omnipod 5 or Omnipod DASH * Get your supplies from US MED  or call 888-721-1514 Learn about Touched By Type 1 Take the T1DExchange survey *The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.  A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on Apple Podcasts. Thank you! The Juicebox Podcast is not a charitable organization.  

On the final episode of The Rob and Eritrea Show of 2023, the gang wraps up the highs, the lows, and a whole lot more: * Some of their favorite moments from the forty-three episodes published in 2023 * Being the #1 podcast on Spotify wrapped for some of our listeners and some other surprising stats * Hosting four first-time events, some virtual, some in person, some local, some not * Our expanding collaboration and relationship with the North Texas Food Bank * Making it to the Top 20 of the DCB Innovation Challenge and what we learned during that process * Cementing the mission of DDT in 2023 at the CWD conference as a team * A bit about our 2024 programming and what more is on the horizon As we close out the year and reflect on all the work we put in, we are truly grateful to each and everyone one of you who gets anything out of these episodes. We couldn't do it without you! Big shoutout and Thank you to some of our sponsors this year: Medtronic, Mannkind, Xeris, Insulet, SkinGrip, Diabetes Link, Swoon, Belay, and more! Happy Holidays and see you in 2024!

It's not often that we get to talk to the partners that help us to be able to create this podcast. On this episode, Rob talks to the CEO of MannKind Corporation, Michael Castagna. They discuss: * Being a doctor of pharmacy and then getting an MBA at a top-tier school * Working on the HIV drug that became the first once-a-day one pill regimen * Becoming a CEO of a pharma company could expand his ability to help more people * Having doubts in self-confidence from being a kid who grew up in poverty * Being an expert in two fields * Inhaled insulin still not being widely known * Becoming a patient himself * The legacy of Alfred Mann and the continued mission to help patients * Mission to help patients vs. the money going to middlemen * What's coming up for MannKind in 2024 o More tools and options for patients Like he said in the episode, if you have access issues - you can get help here to find a doctor or you can email him directly at mcastagna@mannkindcorp.com

Have you wanted to enter the mind of an up and coming CEO? Sitting down with Dr. Michael Castagna was a pleasure. You will learn so much about how to grow into the industry side of pharmacy and he really sheds light on a very different side of pharmacy and healthcare. He has been thriving in the pharmaceutical industry and has been around specialty pharmacy for the past 25 years. I know I took notes on his books that he recommends. Find him on LinkedIn!

This special #sponsored episode features Stargirl herself, Brec Bassinger! This episode is sponsored by Mannkind, and is part of Diabetics Doing Things ongoing partnership with Mannkind. If you want to see Brec in Stargirl, it's streaming in all places that stream the CW including HBOMax. Season 3 is out now. In this episode, Rob and Brec talk about: How they both have January diagnoses in DFW area children's hospitals Balancing diabetes with a Superhero's schedule Life on set The importance of friends with diabetes Becoming an advocate and spokesperson Favorite reality TV…hint: it's Selling Sunset Which celebrity they'd challenge to a pickleball match And MORE We want to hear from you. Send your questions, comments, queries, and general diabetes concerns to THE MAILBAG at mailbag@diabeticsdoingthings.com!

REMINDER: This podcast should not be considered medical advice. Please speak to your doctor to determine whether Afrezza is right for you.I am thrilled to release this episode with Michael Castagna PharmD, CEO of MannKind. MannKind is the maker of Afrezza, the inhaled insulin. Listen back to Episode 25 released on May 18, 2022 (link below) if you want my initial impressions of Afrezza. As you may have gathered from listening to this podcast, I'm a huge fan of Afrezza. It has completely changed how I manage my diabetes and it has greatly simplified my daily routine. Afrezza is a game changer for people that take insulin (both Type 1 and Type 2 diabetics).Michael provides tons of useful information about what Afrezza is, how dosing works, who Afrezza is appropriate for, how to get a prescription, how to pay for it, etc. We go in-depth on some really important topics and I think you will find this episode to be extremely useful.If you are interested in Afrezza, please reach out to Afrezza Assist to get the process started. They are extremely helpful and will let you know what to expect as you speak to your doctor, insurance company, and pharmacy. https://afrezzaassist.comEpisode Links:Episode 25 - my initial thoughts on Afrezza https://stream.redcircle.com/episodes/a48ce257-6477-4472-a7b2-3ecebeab6c00/stream.mp3Afrezza FAQs: https://afrezza.com/faqs/Prescribing doctors: https://afrezza.com/find-a-doctor/Afrezza Assist: https://afrezzaassist.com

Mike Castagna, PharmD, MBA, discusses his journey to becoming CEO of MannKind (NASDAQ: MNKD) https://mannkindcorp.com/

It's in the news! Got a few minutes? Get caught up! Top stories this week: new research that keeps beta cells safer after transplant, a new drug for type 2 also shows weight loss success, the makers of Afrezza buy a simple patch pump, Beyond Type 1 tackles mental health and diabetes and lots more! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story, another approach to beta cell encapsulation. There are a few methods being tested to protect the transplanted cells from the body's immune system. A new and promising one seems to be a new biomaterial in the form of microgel beads. This study was in mice only but after three months the beta cells survived and maintained blood sugar levels with no rejection drugs. Interestingly, this study put the cells into the omentum, not the liver as is apparently the usual spot. I never heard of the omentum.. in case you haven't, it's a layer of tissue connecting the stomach with the other abdominal organs. It's non-vital so it's safer if any complications take place. No word on when human trials might begin here. https://newatlas.com/medical/microgel-beads-safer-path-cell-transplants-treat-diabetes/ XX FDA approval for a new injection for type 2 diabetes called Mounjaro. It's made by Eli Illy and is shown to lower blood sugar and can help patients lose weight. Existing medicines target a hormone called the glucagon-like peptide-1 that is involved in the control of blood sugar. But Mounjaro targets a second hormone, the glucose-dependent insulinotropic polypeptide, as well. It is the first medicine to target both. While not yet approved as an obesity treatment, it's performed very well in clinical trials for weight loss. One study showed it helped patients lose an average of 16 to 22 percent of their weight: That's on par with bariatric surgery https://www.statnews.com/2022/05/13/fda-approves-lilly-diabetes-drug-that-analysts-expect-to-be-a-big-seller/ XX Big deal for MannKind, the makers of Afrezza inhalable insulin. They're acquiring Zealand Pharma's wearable V-Go Insulin Delivery Device. The V-Go is a patch pump that's meant for people with type 2 – it delivers basal insulin at a set rate all day long and can give boluses only in increments of 2 units of insulin at a time, up to 36 units in 24 hours. The deal is expected to close by the end of the month. https://www.mddionline.com/diabetes/mannkind-acquires-wearable-insulin-device-zealand-pharma XX Young adults who were at risk of food insecurity had an increased incidence of diabetes 10 years later, according to the results of a study from Washington State University. Although previous research has associated food insecurity with a range of health issues, this study showed a connection over time, which could indicate a causal relationship. The investigators could not identify the exact reason for this connection, previous research has shown that food-insecure households often have diets with lower nutritional values. The study results did not indicate differences among ethnicities or races, but they also said that a limitation of the study was the number of minorities in the sample, which could be too low to show a pattern, according to investigators. The investigators plan to evaluate food insecurity risk and health issues within American Indian and Alaska Native and American Indian populations, which they said are often left out of annual reports on food insecurity. XX Beyond Type 1 has a new mental health portal.. announced as part of this Mental Health Awareness Month. The global nonprofit is partnering with BetterHelp to provide affordable mental health resources and services to its online community with two weeks of free, professional online therapy. Beyond Type 1 will continue to expand the resources available on the site.. it's not just for this month. https://beyondtype1.org/mental-health/. XX Another entry into the quest to find a non-invasive way to monitor glucose. Movano Inc reports they have – quote - successfully validated the functionality of its proprietary and patented system-on-a-chip. They say this is designed specifically for blood pressure or glucose monitoring systems. It's very early here.. they are also creating a prototype for clinical studies. But this tech got them a new patent. We're keeping an eye on these non-invasive devices – it remains to be seen if any will be accurate enough to use to dose insulin. https://www.prnewswire.com/news-releases/movano-successfully-completes-functional-testing-of-smallest-ever-custom-mmwave-sensor-designed-for-non-invasive-glucose-and-cuffless-blood-pressure-monitoring-301545710.html XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX Back to the news.. Big candy recall, so heads up if you use any of these for lows. It includes specific varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies due to the potential presence of a very thin metal strand embedded in the gummies or loose in the bag. No illness or injuries have been reported. I'll link up the specific lot and manufacturer information. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mars-wrigley-confectionery-us-llc-issues-voluntary-recall-specific-varieties-skittlesr-gummies XX A college fashion design major has a unique senior project. Naomi Kinnamon spent her senior year working on a collection titled “Type 1 Of A Kind.” This series draws on her experiences as a woman with type 1 diabetes who struggles to find clothing that fits comfortably with her insulin pump. She's lived with type 1 since 6th grade and says the most difficult clothing to find were dresses and jumpsuits. So she designed her own. Kinnamon showed off her designs at SCAD – the Savannah College of Art and Design and I'll link that up in the show notes. https://www.wsav.com/now/scad-senior-designs-clothing-for-women-with-type-1-diabetes/ XX On this week's long format episode, you'll hear about the latest on the iLet Bionic Pancreas. Next week.. Mike Joyce is set to complete an incredible long-distance hiking trail. It's actually three trails – the longest in the US – he'll talk about how he does this with type 1. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.