PODCAST · health
Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives
by Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives
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193
Updates for T1D Treatment in Pregnancy and Pediatrics
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
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Nutrition, Medication, and Treatment in Obesity With Elizabeth Bauer, MD
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue, recorded on-site at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas, Nevada, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Elizabeth Bauer, MD, a clinical endocrinologist and obesity specialist, to discuss key updates in obesity management presented during her “Year in Review” session at the AACE Annual Meeting. Bauer opens by highlighting AACE’s updated obesity algorithm, released in late 2024, which builds on the organization’s prior adiposity-based chronic disease framework and shifts obesity care further away from BMI-centered diagnosis toward a more comprehensive, disease-centric model. She explains the algorithm’s emphasis on anthropometric assessment, adiposity distribution, and obesity staging, noting that clinicians must move beyond weight alone to better identify obesity-related complications and personalize treatment decisions.The discussion focuses on the algorithm’s practical value, particularly its structured staging system and medication tables that help clinicians match pharmacotherapy to obesity-related comorbidities such as diabetes, MASLD, and obstructive sleep apnea. Bauer emphasizes that treatment goals should be complication-specific—for example, modest weight loss may improve glycemia, while greater total body weight reduction is needed for meaningful improvement in MASH. She and the hosts stress that obesity management should prioritize whole-person health rather than weight alone, drawing parallels to the evolution of diabetes treatment toward complication-driven care.The group then turns to emerging pharmacotherapies, with Bauer reviewing several phase 2 and 3 obesity trials involving newer incretin-based agents. She highlights mazdutide, a once-weekly GLP-1–based therapy studied in Chinese populations using lower BMI thresholds more reflective of Asian obesity risk, as well as combination therapies such as semaglutide plus cagrilintide, which demonstrated greater efficacy than semaglutide alone but with substantially higher gastrointestinal adverse effects. Bauer notes that while these agents show impressive weight loss potential, tolerability remains a major clinical challenge, particularly with nausea and dose escalation. A significant portion of the conversation centers on management of GI side effects from GLP-1 receptor agonists. Bauer explains her clinical philosophy of treating obesity like any other chronic disease—avoiding the routine practice of prescribing one medication to manage side effects caused by another whenever possible. While she may prescribe small, limited quantities of ondansetron during titration, she emphasizes that persistent nausea should prompt dose adjustment or medication changes rather than indefinite antiemetic use. The hosts discuss how slower titration strategies in real-world practice often improve tolerability compared with rigid clinical trial protocols and may help optimize long-acting monthly GLP-1 agents currently in development.The episode also reviews bariatric surgery data, including randomized trials comparing laparoscopic banding, sleeve gastrectomy, and Roux-en-Y gastric bypass. Bauer notes that both sleeve gastrectomy and Roux-en-Y demonstrated superior efficacy and fewer complications compared with lap band procedures, while long-term comparisons between sleeve and bypass showed strong outcomes for both, with Roux-en-Y numerically favoring weight loss but often without statistically significant superiority. She also discusses higher reoperation rates among patients initially undergoing sleeve gastrectomy, often due to inadequate weight loss or significant reflux requiring conversion to bypass.The conversation concludes with an important discussion on post-bariatric surgery weight regain and the growing use of GLP-1–based therapies after surgery. Bauer challenges the misconception that surgery “cures” obesity, emphasizing that obesity remains a chronic disease driven by persistent biology, inflammation, and environmental factors even after anatomical intervention. She notes emerging evidence suggesting that GLP-1 therapies used before or after bariatric surgery may improve long-term outcomes and reduce weight regain. She closes by reinforcing the need for clinicians to approach obesity with the same chronic disease mindset applied to diabetes—recognizing that durable management requires ongoing treatment, not a one-time intervention.
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The Push for Early-Stage T1D Screening and Treatment, With Linda DiMeglio, MD, MPH
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue recorded on-site at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas, Nevada, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, interview Linda DiMeglio, MD, MPH, professor of pediatrics and division chief at Indiana University School of Medicine, following her plenary keynote and receipt of the Alan Garber Award. DiMeglio outlines her broad work in type 1 diabetes research, including prevention strategies, beta cell preservation, diabetes technology, TrialNet leadership, and neurocognitive studies in young children living with diabetes.The discussion centers on early-stage type 1 diabetes, with DiMeglio reviewing the evolving framework of risk identification and staging, from genetic predisposition and single autoantibody positivity through stage 1, stage 2, and stage 3 disease. She highlights the growing momentum behind both general population and family-based screening, emphasizing the importance of early detection not only to prevent diabetic ketoacidosis but also to enable timely intervention with disease-modifying therapies. She notes the recent expansion of teplizumab approval down to age 1 for stage 2 disease as a major milestone and describes the broader therapeutic goal as ultimately ending insulin dependence for people living with type 1 diabetes.DiMeglio and the hosts discuss how the field has shifted significantly over the past decade, particularly with the reframing of “cure” as a combination of multiple targeted approaches rather than a single intervention. She underscores the importance of combination immunotherapy strategies, citing recent TrialNet work using rituximab followed by abatacept, as well as the need for more personalized approaches based on individual disease etiology and immune characteristics. She also stresses the need for better intermediate endpoints beyond the traditional 2-year C-peptide model to accelerate therapeutic development and trial efficiency.The group also examines the increasing role of patient and family perspectives in clinical trial design, particularly through TrialNet’s community advisory board, which DiMeglio believes will improve recruitment and trial execution. They discuss the broader implications of immune-modifying therapies in type 1 diabetes, including parallels with oncology treatment models and the potential for these advances to inform management strategies for other autoimmune diseases. DiMeglio also reflects on how these therapies are reshaping endocrinology practice itself, requiring clinicians to become more familiar with immunomodulation, cytokine management, and interdisciplinary care.A major focus of the conversation addresses the complexity of autoantibody interpretation, particularly around GAD antibodies and low-titer positivity. DiMeglio emphasizes that a single positive islet autoantibody test should never be considered definitive and should always be repeated, ideally in a separate gold-standard laboratory such as TrialNet. She explains that antibody specificity varies by type and titer, with higher titers often offering greater diagnostic confidence, while acknowledging ongoing uncertainty around interpretation in adults, diverse populations, and long-standing diabetes. The hosts also discuss the practical challenges of coding, insurance coverage, and patient counseling as early-stage diabetes diagnosis becomes more common.The episode concludes with a discussion of emerging questions around antibody fluctuation over time, circadian variation in antibody measurements, and the role of genetic screening. DiMeglio notes that antibody status may shift over years and may even vary by time of day, introducing additional complexity into monitoring strategies. While genetic risk screening remains promising, she explains that large-scale antibody-based population screening may currently be more practical from a public health perspective. She closes by reinforcing that although much remains nuanced and unresolved, the field is rapidly advancing toward earlier intervention, more individualized treatment, and a fundamentally different future for type 1 diabetes care.
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Orforglipron Availability, Amazon Pharmacy, and Dosing Considerations
The US Food and Drug Administration approval of orforglipron (Fondayo) in April 2026 may mark a pivotal shift in obesity care—particularly as the first oral GLP-1 option designed for flexible, real-world use. Within days, Eli Lilly and Company announced broad availability, including a same-day delivery partnership with Amazon Pharmacy, signaling a rapid move toward improved access following years of supply constraints affecting agents like tirzepatide.Watch on HCPLiveIn this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down the clinical and logistical implications of launch. They highlight a key development nuance: marketed tablet doses (0.8 mg–17.2 mg) are dose-equivalent to capsule formulations used in phase 3 trials, supporting scalable manufacturing without compromising pharmacokinetics.Access and affordability remain central. Pricing caps out-of-pocket costs at $299/month for higher doses, with lower-cost entry tiers and expanded distribution positioning orforglipron among the most accessible GLP-1 therapies to date. With uptake already high—approximately 1 in 8 adults reporting prior GLP-1 use—the hosts emphasize potential for further acceleration.The discussion also extends beyond obesity and type 2 diabetes, exploring early real-world signals in type 1 diabetes suggesting possible cardiovascular and renal benefits without increased safety risks, underscoring the broader clinical trajectory of GLP-1–based therapies.
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The G7 15-Day System and CGM Innovations at Dexcom, With Jessica Castle, MD
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue, host Diana Isaacs, PharmD, is joined by Jessica Castle, MD, vice president of medical affairs at Dexcom, to discuss the company’s recent innovations in continuous glucose monitoring (CGM) and their clinical implications.To open the episode, Castle outlines the launch of the Dexcom G7 15-day system, highlighting its extended wear duration, improved accuracy (MARD ~8%), and strong early adoption among adults. She notes ongoing efforts to optimize sensor longevity, particularly through adhesive enhancements, while acknowledging that pediatric expansion remains under evaluation due to unique wear challenges in children. Integration with automated insulin delivery systems continues to evolve, with further updates anticipated.The discussion then shifts to Dexcom’s newly cleared Smart Basal feature, designed to address persistent clinical inertia in basal insulin titration for type 2 diabetes. Castle explains how clinician-defined parameters within the Dexcom Clarity platform enable automated daily dose adjustments based on CGM data, with the goal of minimizing both hyperglycemia and hypoglycemia. Early data presented at ATTD demonstrate significant improvements in mean glucose (>40 mg/dL reduction) and time in range (>20 percentage point increase), without increased hypoglycemia, underscoring both the safety and efficacy of this approach.Isaacs and Castle also explore recent advancements in Dexcom’s digital ecosystem, including AI-driven meal detection and nutritional analysis within the Stelo and G7 platforms. These tools facilitate real-time behavioral insights, reinforcing CGM’s role as a powerful driver of lifestyle modification. Castle emphasizes the growing integration of artificial intelligence to deliver actionable, personalized feedback while maintaining clinical reliability.Expanding beyond glycemic metrics, Castle reviews emerging real-world evidence supporting CGM use across diverse populations. Retrospective analyses presented at ATTD demonstrate substantial reductions in diabetic ketoacidosis (DKA), including >90% risk reduction in pediatric type 1 diabetes following CGM initiation. Additional registry data in non-insulin-treated type 2 diabetes show meaningful A1C reductions (~0.6%) and associated weight loss, reinforcing the value of CGM beyond insulin-dependent populations. The conversation also highlights complementary benefits when CGM is used alongside newer pharmacotherapies, including GLP-1 receptor agonists and dual incretin agents.The episode further addresses gaps in evidence, particularly in pregnancy. While CGM adoption is increasing and supported by growing data in gestational diabetes, Castle acknowledges limited evidence in preexisting type 2 diabetes during pregnancy. Ongoing studies, including the IMAGINE trial, aim to evaluate earlier CGM implementation and its potential to improve maternal and fetal outcomes, potentially reshaping current screening paradigms.The discussion concludes with a forward-looking perspective on Dexcom’s innovation pipeline. Castle highlights Smart Basal and the G7 15-day system as near-term practice-changing tools, alongside continued advancements in sensor design, accuracy, and usability. Both speakers emphasize the expanding role of CGM as a foundational technology in diabetes management, supporting a more proactive, data-driven, and patient-centered approach to care across clinical settings.Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others.
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FDA Approves Novo Nordisk’s Insulin Icodec-abae (Awiqli) for T2D
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
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2026 AACE Guidelines 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
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Orforglipron Receives FDA Approval for Chronic Weight Management
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
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Q1 2026 Updates from Tandem Diabetes Care, with Laurel Messer, PhD, RN
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!Expanding access to and optimizing use of automated insulin delivery (AID) systems remains a central priority in diabetes care, with recent discussions highlighting practical strategies to improve outcomes across diverse patient populations.In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Laurel Messer, PhD, RN, vice president of medical affairs at Tandem Diabetes Care, to examine evolving approaches to insulin pump optimization and the broader implications for reducing patient burden.
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ATTD 2026 Recap
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
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Orforglipron, Retatrutide, and Other GLP-1 Updates
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a comprehensive update on the rapidly evolving landscape of incretin-based therapies, focusing on newly published and top-line clinical trial data across oral GLP-1 receptor agonists and emerging triple agonists.Key Episode Timestamps00:00:01 Intro00:00:22 Orforglipron in the ACHIEVE-3 trial00:03:30 Side effects from orforglipron00:10:28 Retatrutide in the TRIUMPH-4 trial00:18:26 Topline data on Novo Nordisk's UBT25100:21:47 Price cuts on Ozempic, Rybelsus, and Wegovy in 202700:26:26 Outro
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Launch of the Zepbound KwikPen
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a detailed update on evolving incretin-based therapies, with a primary focus on a significant formulation change for tirzepatide.Key Episode Timestamps00:00:01 Intro00:00:11 Zepbound in the KwikPen00:01:25 Vials versus pens00:02:55 Environmental benefits00:03:53 Pen needles sold separately00:06:30 LillyDirect availability00:07:20 Europe approves 7.2 mg injectable semaglutide00:09:08 Reusable pen concerns00:10:55 Outro
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Implantable Insulin Pumps and Interoperability
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore advances in implantable diabetes technologies, focusing on a novel implantable insulin pump from Portal Diabetes that has received FDA Breakthrough Device designation.Key Timestamps00:00:01 Intro00:00:14 Implantable insulin pumps00:01:06 What is breakthrough status?00:03:00 How the pump works00:03:41 What makes it different from MiniMed?00:07:36 How does it administer insulin?00:09:47 The Twiist pump with EverSense00:13:30 Outro
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Oral Ozempic and the Risks of Compounding Formulas
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore major updates in the evolving GLP-1 receptor agonist landscape, with a particular focus on oral semaglutide formulations, branding changes, and regulatory concerns surrounding compounded alternatives.Key Episode Timestamps00:00:01 Intro00:00:25 Oral Wegovy and oral Ozempic00:03:04 Why Rybelsus didn't work00:05:33 The importance of administration00:06:56 Compounding drugs - the Hims and Hers drama00:07:56 The danger of unregulated compound drugs00:11:50 Outro
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Tech Updates on Twiist, MiniMed Go, and More
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide an in-depth review of several notable developments in diabetes technology, focusing on innovations in insulin pump interoperability, automated insulin delivery algorithms, continuous glucose monitoring, and decision-support tools for people using multiple daily injections (MDI).Key Episode Timestamps00:00:01 Intro00:00:19 The Sequel Twiist00:01:05 Diabeloop's new algorithm00:09:01 Leaving CamAPS behind?00:09:57 Eversense approaching a spring launch00:12:27 MiniMed Go and the InPen00:17:40 Outro
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Reviewing the New US Dietary Guidelines with Susan Weiner, MS
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Susan Weiner, MS, a nationally recognized dietitian and diabetes care and education specialist, for an in-depth discussion of the newly released US Dietary Guidelines and the inverted food pyramid. The conversation is framed for clinicians navigating nutrition counseling in diabetes and cardiometabolic care, with a focus on how these recommendations translate - or fail to translate - into real-world practice.Key Episode Timestamps00:00:01 Intro00:01:00 The new food pyramid and a history of diet guidelines00:03:36 Shortcomings of the new guidelines00:09:33 The headache of food labeling00:11:11 New alcohol guidelines00:13:26 How the guidelines form policy00:14:55 How professional organizations deal with the guidelines00:17:38 Linoleic acid in processed foods00:25:15 Too much protein?00:30:32 Translating the guidelines for patients00:37:11 Outro
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177
Therapeutic Updates from the ADA 2026 Standards of Care
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review key therapy-focused updates from the 2026 ADA Standards of Care, emphasizing areas they view as practice-changing.Key Episode Timestamps00:00:01 Intro00:00:29 Adding GLP-1 RAs to heart failure00:02:45 GLP-1s in glycemic management00:04:36 Time in range targets in glycemic management00:08:10 ADA recommends GLP-1s for T1D00:12:00 GLP-1s in MASH and MASLD00:12:57 Changes in kidney protection guidelines00:14:40 New therapeutic guidance for T1D and T2D00:17:57 Outro
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176
Orforglipron, Cagrilintide, and the Libre Assist
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode of Diabetes Dialogue, cohosts 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 the University Hospitals Diabetes and Metabolic Care Center, review major therapeutic and technology updates in diabetes care, beginning with newly announced topline phase 3 data for orforglipron, the first oral nonpeptide GLP-1 receptor agonist submitted to the FDA.Key Episode Timestamps00:00:01 Intro00:00:15 Orforglipron and ATTAIN-MAINTAIN00:07:33 Cagrelinitide with semaglutide at the FDA00:10:26 The Libre Assist00:18:31 Outro
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175
2026 Technology Updates and American Diabetes Association Standards of Care
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 Chapters00:00:00 - Intro & Agenda: New Tech + 2026 ADA Standards00:00:45 - Dexcom G7 15‑Day Sensor & G6 Retirement00:04:40 - OmniPod Algorithm Update00:09:27 - 2026 ADA Standards of Care00:15:45 - Expanding Diabetes Tech Options00:21:19 - Endorsement of Earlier AID and Open-Source AID Support
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Reacting to Retatrutide and TRIUMPH-4 Topline Data
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
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173
Semaglutide Falls Short in Alzheimer Disease, Tirzepatide Shows Promise in T1D
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 DiseaseNovo 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 DiabetesIn 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
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Updates on Dexcom G7 and Semaglutide Pricing
In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review two major developments in diabetes care: the forthcoming 15-day Dexcom G7 continuous glucose monitor (CGM) and significant new price reductions for semaglutide as Ozempic and Wegovy.Key Episode Timestamps00:00:01 Introduction00:00:30 Dexcom G700:01:55 A 15-Day Sensor With a 12-Hour Grace Period00:04:27 Seamless transition to the new G700:05:23 Looking back at Dexcom's advancements00:06:34 Dexcom's Smart Basal feature00:10:34 Price cuts for semaglutide - Wegovy and Ozempic00:14:54 Cheaper GLP-1s on the pharmacies' end00:20:33 Outro
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171
Oral Semaglutide and SELECT at DTM 2025
In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, meet in person at the Diabetes Technology Meeting (DTM) in San Francisco to discuss the latest clinical and regulatory advances surrounding semaglutide. Key Episode Timestamps 00:00:01 Introduction 00:00:42 Oral semaglutide's FDA approval 00:02:02 The SOUL trial and Rybelsus's cardiovascular indication 00:03:35 Dosing for Rybelsus 00:06:18 The SELECT trial 00:08:29 Can GLP-1s be cardiovascular treatments? 00:14:08 Outro
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170
Biolinq Shine, Insulin Icodec, and Eli Lilly's Pipeline
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore 3 significant developments shaping diabetes care: a novel glucose-sensing technology, the return of once-weekly insulin icodec to the US Food and Drug Administration (FDA), and changes to Eli Lilly’s metabolic research pipeline.00:00:01 Introduction00:00:18 The Biolinq Shine00:05:59 The Practicality of Monitoring Glucose00:06:55 Wishlist for the Biolinq's Future00:08:38 Insulin Icodec Resubmission00:10:21 Benefits of Once-Weekly Insulin00:14:00 International Success Stories00:15:28 Eli Lilly Cancels Bimagrumab for T2D00:18:36 Bimagrumab Still in Testing for Obesity00:22:49 Outro
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169
Celebrating 150 Episodes!
In this milestone 150th 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 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, reflect on three and a half years of transformation in diabetes care and the evolution of their podcast since its launch in early 2022. What began as a modest plan for monthly discussions rapidly expanded into a weekly forum driven by an ever-accelerating pace of clinical innovation and the hosts’ shared enthusiasm for translating emerging science into practice.
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168
What's New at Medtronic Diabetes With Bob Vigersky, MD
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, sit down with Bob Vigersky, MD, Chief Medical Officer of Medtronic Diabetes, to discuss major developments in diabetes technology, regulatory approvals, and the company’s future direction.00:00:00 Introduction00:00:27 Background of Bob Vigersky, MD00:02:40 Updates from Medtronic Diabetes00:08:02 The Instinct Sensor00:10:20 Calibrating New Devices00:12:27 Moving to Type 200:15:00 Bolusing with New Devices00:17:39 Looking Down the Pipeline00:22:07 Prescribing the MiniMed00:35:45 Outro
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167
Results of ATTAIN-1 and STEP UP Phase 3 Trials
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this 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 Hospital Diabetes and Metabolic Care Center, discuss the recently published results of the ATTAIN-1 and STEP UP clinical trials, both of which were presented at the European Association for the Study of Diabetes (EASD) 2025 Conference.00:00:00 Introduction00:00:32 ATTAIN-100:04:07 GLP-1s as a Daily Pill00:08:20 Possible Lower GLP-1 Prices00:09:03 STEP UP00:11:41 Cardiovascular Protection with GLP-1s00:12:48 GI Side Effects of Semaglutide 7.200:16:16 3 Times the Dose, 3 Times the Cardiovascular Protection?00:17:20 Outro
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166
Milestones for MiniMed 780G and Signos CGM for Weight Loss
In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, 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, breakdown recent diabetes technology updates from late August and early September 2025.
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Semaglutide & Tirzepatide Updates at ESC Congress 2025
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
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FDA Approves Semaglutide (Wegovy) for MASH
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this 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 the latest milestone for semaglutide (Wegovy): US Food and Drug Administration (FDA) approval for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced fibrosis. They frame the decision as a breakthrough in addressing a disease that affects an estimated 6% of the U.S. population, with even higher prevalence among individuals with type 2 diabetes and obesity. MASH, often underrecognized and asymptomatic in its early stages, carries serious long-term consequences, including cirrhosis, hepatocellular carcinoma, liver transplantation, and premature mortality.00:00:00 Introduction00:00:32 Semaglutide (Wegovy) Approval00:06:31 Novo Nordisk Announces Ozempic Price Change00:08:21 Compounding Pharmacies00:10:57 The Future of Semaglutide
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163
ADCES 2025 Part 3 & Diabetes Tech Updates
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, 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, shared highlights on several major insulin delivery updates making waves at recent meetings.00:00:00 Introduction00:00:20 Pivot by Modular Medical00:07:13 Medtronic's Partnership with Abbott - the Instinct Sensor00:09:04 Tandem's One-Handed Insert00:10:14 Tandem's Mobi Patch Pump
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ADCES 2025 Recap Part 2
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!In this episode, 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, highlight key advancements in diabetes management, particularly in continuous glucose monitoring (CGM) during pregnancy and the anticipated future of continuous ketone monitoring, from Association of Diabetes Care and Education Specialists (ADCES) 2025 annual meeting.00:00:00 Introduction00:00:30 Continuous Glucose Monitoring in Pregnancy00:04:59 Stello versus Finger Sticks for Insulin Dosing00:13:43 Innovative Presentations at ADCES00:14:36 Ketone Monitoring00:18:15 Product Theaters and Gamification at ADCES
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161
Orforglipron Topline Results & ADCES 2025 Part 1
In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, share key insights and takeaways from the Association of Diabetes Care and Education Specialists (ADCES) 2025 annual meeting.00:00:00 Introduction00:00:25 Orforglipron and the ATTAIN-1 study00:01:29 Why orforglipron is exciting00:04:21 ADCES - Incredible Incretins00:10:33 ADCES - AI in diabetes management00:12:59 New AI tools for endocrinology00:19:01 ADCES - Implicit bias00:21:30 Closing
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Tirzepatide and SURPASS-CVOT Topline Results
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
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159
Guideline Updates for Diabetes & Pregnancy
Welcome back to Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives!In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the newly released Preexisting Diabetes in Pregnancy guidelines from The Journal of Clinical Endocrinology & Metabolism, which offer 10 key recommendations to improve outcomes in pregnant individuals with type 1 or type 2 diabetes.00:00:00 Intro00:01:25 Recommendations 1 and 200:02:27 Recommendation 300:07:11 Recommendation 400:09:58 Recommendation 500:14:51 Recommendations 6 and 700:19:05 Recommendation 800:23:11 Recommendation 900:25:11 Recommendation 10
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158
GLP-1s, SGLT2s, and Diabetes Barbie at ENDO 2025
Welcome back to Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives!In this episode of Diabetes Dialogue, cohosts 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, recapped highlights from the 2025 Endocrine Society annual meeting. They spotlighted advances, controversies, and ongoing unmet needs in type 1 diabetes care.00:00:00 Intro00:00:40 GLP-1 RAs in type 1 diabetes00:05:50 Tirzepatide in type 1 diabetes00:08:32 Cardioprotective therapies in type 1 diabetes00:12:17 Type 1 diabetes Barbie and public education
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157
Upcoming Research on Type 1 Diabetes in Pregnancy with Carol Levy, MD
In this episode of Diabetes Dialogue, cohosts 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 Carol Levy, MD, director of the Mount Sinai Diabetes Center and Type 1 Diabetes Clinical Research, to discuss the upcoming T1D Pregnancy and Me – or PRAM T1D – clinical study.Enrollment for T1D Pregnancy & Me is currently open. Interested listeners can enroll at https://www.mountsinai.org/clinical-trials/t1d-pregnancy-me.00:00:00 Introduction00:01:43 The "why" behind the trial00:04:24 The structure of the study00:07:37 Will maternal outcomes be collected?00:08:12 Can patients enroll themselves in this trial?00:12:40 No devices will be excluded00:15:20 Dividing data based on first versus later pregnancies00:18:14 Will you continue to enroll after the first 500?
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156
BELIEVE, GLP-1/GIP Agonists, and CATALYST Results at ADA 2025
In this episode of Diabetes Dialogue, cohosts 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, continue their recap of ADA’s 2025 Scientific Sessions, spotlighting 3 more of the top clinical trials focused on obesity and type 2 diabetes.00:00:00 Intro00:00:31 BELIEVE Trial00:08:11 Phase 2 Maritide Trial00:17:12 CATALYST-2
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155
American Diabetes Association 2025 Trial Recap - Part 1
In this episode of Diabetes Dialogue, cohosts 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, recap some of the biggest clinical trials presented at the American Diabetes Association (ADA) 2025 conference in Chicago, Illinois.00:00 Introduction2:04 The Vertex Trial6:57 The T1D Trial15:23 The Achieve 1 Trial
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154
The Diabetes Collective, with Rachael Sood, RN, MSN, APRN
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.
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153
Addressing America's Shortage of Diabetes Care Providers, with Jay Shubrook, DO, & Conan Tu, MD
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.
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152
CATALYST Trial, Mifepristone, and Hypercortisolism in T2D, with John Buse, MD, PhD
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.
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151
Updates from Dexcom at ADA 2025, with Kevin Sayer
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.
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150
REDEFINE 1 and REDEFINE 2, with Timothy Garvey, MD, and Melanie Davies, MD
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/NEJMoa2502081Davies 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
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149
ADA 2025 Preview
With a number of late-breaking presentations and high-profile phase 2 and 3 trials, the 2025 American Diabetes Association (ADA) Scientific Sessions reflect how rapidly the treatment landscape for obesity and diabetes is evolving. This year’s meeting, held June 20–24 in Chicago, will showcase significant updates on combination therapies, once-weekly insulin regimens, and novel mechanisms that may redefine standards of care for both type 1 and type 2 diabetes.Among the highlights: new efficacy and safety data for GLP-1–based therapies, novel amylin analog combinations, and once-monthly treatment options signal a shift toward personalization and convenience in metabolic care.In this special episode of Diabetes Dialogue cohosts 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, preview the most anticipated data, explore clinical implications, and discuss what may come next in the exciting pipelines for diabetes and obesity.During the meeting, Isaacs will also participate in a debate on over-the-counter continuous glucose Monitoring with David Ahn, MD, of Hoag, on Friday, June 20, and Bellini will chair 2 sessions, “Real-World Automated Insulin Delivery System Results” on June 20, and “Advances and Trends in Diabetes Technology” on June 22.
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148
American Diabetes Association Consensus Report on MASLD
In this episode of Diabetes Dialogue, cohostsDiana 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, examine a newly released American Diabetes Association (ADA) consensus report titled Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People with Diabetes: The Need for Screening and Early Intervention. The publication emphasizes the importance of recognizing MASLD as a critical comorbidity in individuals with type 2 diabetes and prediabetes and outlines guidance for clinicians to improve early detection, risk stratification, and treatment strategies.The episode begins by placing MASLD in historical context alongside other comorbidities such as cardiovascular disease, chronic kidney disease, and hypertension. The hosts explain that MASLD, previously referred to as nonalcoholic fatty liver disease or NAFLD, reflects a metabolic-driven pathology and is now better understood as a progressive condition that increases the risk of cirrhosis, liver transplantation, cardiovascular disease, and impaired quality of life. The more advanced form, MASH (Metabolic dysfunction-associated steatohepatitis), represents progression toward hepatic fibrosis and cirrhosis.A major focus is the Fibrosis-4 (FIB-4) score, a noninvasive, cost-effective screening tool calculated from common laboratory tests (platelets and liver function markers) to assess fibrosis risk. The consensus report advises routine FIB-4 scoring in adults with type 2 diabetes, particularly those with central obesity. Based on risk thresholds, further evaluation may involve transient elastography (FibroScan), advanced imaging, or hepatology referral.The hosts commend the ADA for offering a clear clinical algorithm for evaluation and referral, as well as pharmacotherapy recommendations tailored to disease severity. For individuals with early-stage fibrosis, lifestyle modification and diabetes therapies such as GLP-1 receptor agonists (eg, semaglutide) are first-line approaches. For advanced fibrosis (F2–F3), resmetirom is the only currently approved treatment for MASH. The report also highlights complications from hepatic dysfunction—including impaired hypoglycemia awareness and sarcopenia—underscoring the broader metabolic impact of MASLD.Isaacs and Bellini stress that MASLD should be approached with the same clinical rigor as other diabetes-related complications. They recommend integrating automated FIB-4 scoring in EHRs, interdisciplinary collaboration with hepatology, and clinician education using decision tools from the consensus report.Reference:Cusi K, Abdelmalek MF, Apovian CM, et al. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People With Diabetes: The Need for Screening and Early Intervention. A Consensus Report of the American Diabetes Association. Diabetes Care. Published online May 28, 2025. doi:10.2337/dci24-0094
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147
May 2025 Diabetes Tech & Breakthrough T1D Updates
In this episode of Diabetes Dialogue, co-hosts 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 significant developments in diabetes care from May 2025, including Medtronic’s restructured business model, Sequel Twiist’s technological collaboration with Abbott, and Breakthrough T1D’s efforts to advance early detection of type 1 diabetes (T1D) through national screening initiatives.The discussion opens with news of Medtronic’s decision to spin off its diabetes division into a standalone entity, currently referred to as “New Diabetes Company.” While the final name is forthcoming, the move is intended to streamline operations and accelerate innovation within the diabetes space. The hosts highlight the company’s promising technology pipeline, including the forthcoming 800 series insulin pump with full smartphone control and plans for a tubeless insulin delivery system. Both experts express optimism that the independence may foster greater agility in product development, enhance accessibility, and maintain a focus on user-centered design, including for populations with visual impairments.Next, Isaacs and Bellini examine the announcement of the Sequel Twiist partnership with Abbott to integrate continuous ketone monitoring (CKM) into a hybrid sensor, which is expected to function similarly to the FreeStyle Libre 3. This device, still in development, will provide real-time data on both glucose and ketone levels—a critical advance for people with type 1 diabetes using insulin pumps, who are at elevated risk for diabetic ketoacidosis (DKA). While excited about the potential for earlier DKA detection, Bellini emphasizes the importance of cost-effective implementation and integration with existing pump platforms.The episode concludes with coverage of Breakthrough T1D’s advocacy before the US Preventive Services Task Force to support routine screening for T1D autoantibodies. The goal is to identify individuals in early stages of the disease to prevent DKA and misdiagnosis. The hosts note that despite advancements in understanding T1D progression, many patients remain undiagnosed until presenting with DKA or are mistakenly classified as having type 2 diabetes.References: Medtronic plc. Medtronic announces intent to separate Diabetes business. Medtronic News. Published May 21, 2025. Accessed June 2, 2025. https://news.medtronic.com/2025-05-21-Medtronic-announces-intent-to-separate-Diabetes-business Sequel Med Tech. Sequel Med Tech to Integrate twiist Automated Insulin Delivery (AID) System with Abbott’s Future Dual Glucose-Ketone Sensor. GlobeNewswire News Room. Published May 22, 2025. Accessed June 2, 2025. https://www.globenewswire.com/news-release/2025/05/22/3086535/0/en/Sequel-Med-Tech-to-Integrate-twiist-Automated-Insulin-Delivery-AID-System-with-Abbott-s-Future-Dual-Glucose-Ketone-Sensor.html Breakthrough T1D. Breakthrough T1D Submits Application to Make Screening for Type 1 Diabetes Part of Recommended Preventive Services in the US - Breakthrough T1D. Breakthrough T1D. Published May 21, 2025. Accessed June 2, 2025. https://www.breakthrought1d.org/for-the-media/press-releases/breakthrough-t1d-submits-application-to-make-screening-for-type-1-diabetes-part-of-recommended-preventive-services-in-the-us/
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146
INHALE-3 Trial and Afrezza, With Roy Beck, MD, PhD
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.Chapters00:00:01 Introduction and Background of Dr. Roy Beck00:02:16 Overview of Inhaled Insulin00:06:31 INHALE-1 Pediatric Study00:07:21 INHALE-3 Adult Study00:11:18 Study Results and Participant Outcomes00:19:57 Challenges and Future Directions00:26:44 Side Effects and Safety Concerns00:31:09 Conclusion and Final Thoughts
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145
Diabetes Dialogue: AACE 2025 Recap
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.
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144
Real-World Impact of iLet Bionic Pancreas, With Steven Russell, MD, PhD
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 <70 mg/dL, 1.6%; time <54 mg/dL, <0.3%).Crucially, the iLet’s performance remains consistent regardless of user engagement. Patients who announced meals more than four times daily experienced only a 0.4% greater GMI improvement compared to those announcing meals once every three days. This supports its use in underserved populations and those with a high diabetes burden. The algorithm also adapted effectively in the presence of prior long-acting insulin, though Russell recommended limiting such adjunct therapy to no more than 50% of estimated basal needs.Isaacs and Bellini highlighted the clinical significance of the iLet's ability to lower A1c while simultaneously reducing hypoglycemia—a rare achievement in diabetes therapy. The episode also explored the iLet’s off-label use in type 2 diabetes (T2D). While formal trials are ongoing, preliminary data from MDI-treated T2D users suggest similarly favorable outcomes.A forthcoming trial will test the iLet in primary care settings for both T1D and T2D. Early results from a pilot study found no difference in glycemic outcomes whether training was delivered by endocrinologists or primary care providers, reinforcing the system’s potential to expand access to AID beyond specialty care.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 Timestamps00:00:01 Introduction and Guest Introduction00:01:12 Early Research and Development00:02:30 Real World Data Overview00:26:08 Impact of Islet on A1C and Hypoglycemia00:26:25 Clinical Considerations and User Engagement00:27:02 Real-World Data Analysis and Future Studies00:32:05 Conclusion and Future Prospects
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