Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives

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.

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

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/

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

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

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

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

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! Full results from the SURMOUNT-5 trial show tirzepatide (Zepbound) led to significantly greater weight loss than semaglutide 2.4 mg (Wegovy) in adults with obesity, according to findings published in The New England Journal of Medicine and presented at the 32nd European Congress on Obesity. “The SURMOUNT-5 head-to-head results demonstrated tirzepatide led to greater weight reduction compared to semaglutide, providing further evidence to support tirzepatide as an effective option for obesity management,” said principal investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, in a press release. The phase 3b trial enrolled 751 participants across 32 US and Puerto Rican sites, with 750 receiving at least one dose of study drug. Participants were randomized to their maximum tolerated dose of tirzepatide (10 mg or 15 mg) or semaglutide (1.7 mg or 2.4 mg). The primary endpoint was percent change in body weight at 72 weeks. Results showed tirzepatide produced a 20.2% average reduction in body weight versus 13.7% with semaglutide, a 6.5-point difference (P

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

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

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

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

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

Video Version Only on HCPLive! 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, explored two key trial updates in type 2 diabetes (T2D) care at the American College of Cardiology (ACC) 2025 Annual Scientific Sessions. SOUL Trial SOUL, a double-blind, placebo-controlled, event-driven trial, was designed to assess the cardiovascular effects of oral semaglutide (Rybelsus) in patients with T2D and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). A total of 9650 patients aged ≥50 years were enrolled across 450 centers in 44 countries. Analyses showed oral semaglutide (Rybelsus) was linked to a 14% reduction in major adverse cardiovascular events (MACE) in high-risk patients with T2D. This reduction included the incidence of cardiovascular (CV) death, myocardial infarction (MI), or stroke compared to placebo (HR, 0.86; 95% CI, 0.77 to 0.96; P = .006) over a median follow-up of 47.5 months. A 26% reduction in non-fatal MI was the primary driver of benefit, while safety findings identified gastrointestinal adverse events as more common with oral semaglutide. Based on these results, Novo Nordisk announced plans to pursue regulatory approval for a label expansion of oral semaglutide to include MACE risk reduction in adults with T2D and established CV disease. STRIDE Trial STRIDE, a double-blind, randomized, placebo-controlled trial initiated in 2020, assessed the effects of semaglutide 1.0 mg (Ozempic) on functional outcomes, including walking distance, in patients with T2D and peripheral artery disease (PAD). Conducted across 112 sites in 20 countries, the trial randomized 792 patients to receive semaglutide or placebo for 52 weeks. Analyses showed semaglutide use was associated with improvements in maximal walking distance, quality of life, and ankle-brachial index (ABI). SOUL met its primary endpoint, with semaglutide favoring the ratio from baseline in maximum walking distance at 52 weeks (1.21 [interquartile range, 0.95–1.55] vs 1.08 [0.86–1.36]), with an estimated treatment ratio (ETR) of 1.13 (95% CI, 1.06–1.21; P = .0004). At week 57, the improvement in walking distance was higher with semaglutide (ETR, 1.08; P = .038). Quality-of-life scores (VascuQoL-6) at week 52 were significantly higher in the semaglutide group (median difference, 1.00; P = .011), as were improvements in pain-free walking distance (ETR, 1.11; P = .0046). 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. Editor's Note: In this episode, there was an error in the discussion about the new dosing for Rybelsus in the SOUL trial. The corrected information is that the 14 mg dose is now 9 mg with the new formulation, due to improved absorption. The full corrected statement is: “Instead of 3 mg, the new dose is 1.5 mg; instead of 7 mg, it's 4 mg; and instead of 14 mg, it's 9 mg.”

Video Version Only on HCPLive! 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, reflect on major announcements and product updates from the Advanced Technologies & Treatments for Diabetes (ATTD) 2025 annual conference. The conversation opens with insights into Medtronic's new Simplera CGM, emphasizing its single-use, disposable design and fully disposable on-body form factor. The hosts highlight improvements over previous iterations, such as the absence of an inserter and a more streamlined adhesive system. Although accuracy data have yet to be released, Medtronic has initiated a pivotal trial, and expectations are high for competitive MARD performance. They then turn to Tandem Diabetes Care's Tandem Mobi pump, recently launched in the US market. The pump's compact size and phone control interface are praised for improving convenience and discretion. Bellini underscores how Mobi shifts the paradigm for pump wearability, with early feedback from patients indicating high satisfaction. Later, the hosts discuss Beta Bionics' insulin-only iLet Bionic Pancreas system, which has expanded availability in the U.S. They review recent clinical updates and ongoing efforts to integrate real-world user data. The system's unique algorithm, which doesn't require manual carb counting or standard pre-programming, continues to generate interest across clinical settings. Additional topics include anticipated innovation from Lilly's new pump platform, the competitive implications for CGM integration, and an emphasis on patient-centered device design. The episode closes with Isaacs and Bellini reflecting on the rapid evolution of diabetes technology and how practitioners can stay current with emerging tools and evidence-based practices. 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. Editor's Note: Control-IQ+ technology is cleared by the FDA for use in adults with type 2 diabetes in the United States, as of February 25, 2025. The podcast episode erroneously positioned the indication as forthcoming. On March 18, 2025, Tandem Diabetes Care announced the commercial launch, making Control-IQ+ available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes.

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center speak with Laurel Messer, PhD, RN, senior director of medical affairs at Tandem Diabetes Care, about the latest advancements in Control-IQ+, the company's next-generation automated insulin delivery (AID) technology. With clearance received from the US Food and Drug Administration (FDA) in February 2025, Tandem announced on March 18, 2025, that the Control-IQ+ hybrid closed-loop algorithm is now available for use in adults with type 2 diabetes (T2D) aged ≥18 years alongside people with type 1 diabetes (T1D) aged ≥2 years. Enhancements to the algorithm included a broader weight range (20–440 lbs) and insulin dosing parameters (5–200 units), representing a more inclusive algorithm. In this episode, Messer highlighted other new features in the updated algorithm, such as temp basal rate adjustments for exercise or illness and an extended bolus option of up to eight hours, which enhances flexibility in insulin management during meals. Messer also emphasized that Control-IQ+ offers a unique advantage: the ability to fine-tune correction factors, allowing providers to tailor insulin delivery for improved glycemic control. With the AutoBolus feature, Control-IQ+ predicts and corrects hyperglycemia every hour, significantly benefiting individuals who struggle with consistent mealtime bolusing. 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. Important Safety Information: RX ONLY. Indicated for patients with type 1 diabetes, 2 years and older and for patients with type 2 diabetes, 18 years and older. BOXED WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds, as those are the required minimum values needed for Control-IQ+ to operate safely. Safety info: tandemdiabetes.com/safetyinfo.

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss a pair of recently published studies examining the use of diabetes technology in adults with type 2 diabetes. SECURE-T2D A single-arm prospective study conducted at 21 US clinical centers, SECURE-T2D assessed the impact of automated insulin delivery (AID) on glycemic control in adults with type 2 diabetes using insulin for at least 3 months. The study enrolled 305 participants (mean age, 57 years; 57% female), with a diverse racial and ethnic representation, including 24% Black and 22% Hispanic or Latino. Following a 14-day standard therapy phase, participants used the Omnipod 5 AID system for 13 weeks. HbA1c decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (mean difference, -0.8 percentage points; 95% CI, -1.0 to -0.7; P

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and 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, explore the updated American Diabetes (ADA) 2025 Standards of Care, focusing on therapeutic advancements in diabetes management. Hosts discussed the significant changes to treatment algorithms and new guidance designed to enhance outcomes for people with diabetes and related conditions. One of the major updates discussed is the expanded flexibility in the treatment algorithm for type 2 diabetes (T2D) and chronic kidney disease (CKD), including glucagon-like peptide-1 receptor agonists (GLP-1 RA), such as semaglutide, as an alternative to patients who may not tolerate sodium-glucose co-transporter 2 (SGLT2) inhibitors. Isaacs and Bellini emphasized the complementary benefits of combining these therapies, particularly for kidney protection and glucose management. The episode also highlighted updates on the use of GLP-1 RAs for patients with obesity-related heart failure with preserved ejection fraction (HFpEF), underscoring the evolving role of these medications beyond glucose lowering. The discussion then shifted to the introduction of recommendations for metabolic dysfunction-associated steatotic liver disease (MASLD) and steatohepatitis (MASH). GLP-1 RAs, dual GLP-1/GIP agonists, and combinations with pioglitazone are now recognized as promising treatment options to mitigate these risks. Hosts delved into the importance of identifying disease severity using FIB-4 scores and how these guidelines aim to address the rising prevalence of fatty liver disease among people with diabetes. Another noteworthy update focused on screening for type 1 diabetes (T1D), particularly in first-degree relatives of individuals with the disease. Isaacs and Bellini review the new staging framework, which classifies T1D progression into three distinct stages, and the inclusion of ICD-10 codes for accurate diagnosis. They also discussed the role of teplizumab (TZIELD) in delaying disease progression in individuals aged ≥8 years and what this could represent for early intervention. With practical insights and real-world applications, this episode provided a comprehensive look at how these updates from the ADA's 2025 Standards of Care will shape therapeutic decision-making and improve care for people with diabetes. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00 Updates to 2025 ADA Standards of Care 03:06 GLP-1 Agonists and SGLT2 Inhibitors Combination Therapy 04:34 Heart Failure Stratification and Obesity-Associated Heart Failure 07:04 Introduction of Liver Disease into Algorithms 10:28 Screening for Type 1 Diabetes and New Guidelines 13:57 Guidelines for Pre-Symptomatic Type 1 Diabetes 17:35 Nutrition and Medication Adjustments 20:45 Vitamin D Monitoring and Supplementation 22:12 ADA Standards of Care App

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! 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, explore the updated American Diabetes (ADA) 2025 Standards of Care, focusing on technology advancements in diabetes management. The discussion highlighted significant advancements and updated recommendations in diabetes care, particularly surrounding continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems. In particular, hosts pointed to stronger ADA recommendations for CGM use, including for individuals with type 2 diabetes (T2D) not on insulin therapy, and emphasized the importance of CGM for all patients on insulin therapy to reduce hypoglycemia risks. They also touched on the potential of over-the-counter CGMs to guide medication adjustments and lifestyle changes for prediabetes and T2D. A notable topic is the ADA's revised stance on open-source AID systems, explicitly asking clinicians to support and guide patients who use these open-source systems. In particular, the organization recognized its potential to improve outcomes and urged providers to understand the underlying algorithms as they continue to advance. Isaacs and Bellini also highlighted the role of CGM and AID systems during pregnancy, emphasizing the early initiation of technology to achieve personalized glycemic targets and optimize outcomes. The discussion expanded on the seamless integration of CGM during hospital discharge programs, as well as ADA recommendations that AID systems become the preferred insulin delivery method for people with type 1 diabetes (T1D), with growing support for their use in T2D on basal or multiple daily insulin injections. They addressed challenges such as Medicare restrictions on pump coverage for T2D, and insurance denial of test strips for CGM users, emphasizing the critical need for test strips as backups during CGM failures. Their conversation also zeroed in on the ADA's new guidance on allowing insulin pump use during hospitalization when clinically appropriate. Bellini stressed the importance of patient independence and education, advocating for hospitals to enable pump use if patients or caregivers can manage them. Hosts underscored the importance of patients bringing sufficient supplies to hospitals, as most facilities do not stock them. Throughout the episode, Isaacs and Bellini emphasized the transformative potential of diabetes technology, urging clinicians to embrace and adapt to advancements to better support patients. They advocated for empowering individuals to manage their care, educate healthcare providers, and push for policy changes that improve access, equity, and outcomes in diabetes management. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:01 Introduction, Updates on CGM for Type 2 Diabetes 03:14 Support for Open Source AID Systems 09:14 Improved Guidelines for AID and Pregnancy 13:34 Early Initiation of CGM and AID 18:46 Advocacy for CGM and Test Strips 21:52 Insulin Pumps During Hospitalization 25:35 Conclusion

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Allison Evert, MS, RD, CDCES, and Savitha Subramanian, MD, co-authors of a recent publication on the evolving role of registered dietitian nutritionists (RDNs) in incretin-based therapies and obesity care, titled "Incretin-Based Therapies and Lifestyle Interventions: The Evolving Role of Registered Dietitian Nutritionists in Obesity Care". The conversation explores how combining GLP-1 receptor agonists with lifestyle interventions can enhance long-term outcomes in diabetes and obesity management, focusing on the integral role of RDNs in addressing medication adherence, side effects, and patient education. Evert and Subramanian highlight key findings from their paper, including strategies for mitigating side effects such as nausea, constipation, and diarrhea, which contribute significantly to high discontinuation rates during the first year of therapy. They stress the importance of counseling patients on appropriate dietary adjustments to prevent nutrient deficiencies and muscle loss during rapid weight loss, recommending an emphasis on protein intake and nutrient-dense food choices. The discussion also delves into the practical challenges of integrating RDNs into care teams, particularly in systems with limited resources. To address this gap, the authors provide actionable tools in their paper, including figures and resources to guide clinicians in patient education and medication management. The hosts and guests agree that team-based care, including the use of pharmacists, advanced practice providers, and clinical protocols, is critical to improving outcomes and ensuring the long-term success of these therapies. 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: Gigliotti L, Warshaw H, Evert A, et al. Incretin-Based Therapies and Lifestyle Interventions: The Evolving Role of Registered Dietitian Nutritionists in Obesity Care. J Acad Nutr Diet. Published online November 7, 2024. doi:10.1016/j.jand.2024.10.023

Video version only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, speak with Eran Atlas, chief executive officer of DreaMed Diabetes, on the evolution and current functionality of his company's automated insulin technology, originally developed within a prominent diabetes treatment center in Israel, and now integrated with Medtronic's 780G system. Atlas Described how DreaMed Diabetes started focusing on automated insulin delivery but has expanded into developing a comprehensive digital care platform. This platform, called endo.digital, is designed to optimize insulin therapy for people with diabetes using AI-driven algorithms. It can gather data from various devices, including continuous glucose monitors (CGMs) and insulin pumps, analyze it, and offer tailored insulin recommendations to providers, which can be automatically integrated into the patient's medical records. Atlas further explained how the platform supports both insulin pump users and those on multiple daily injections (MDI). Hosts discussed how this algorithm could detect potential issues, such as incorrect carb ratios, missed insulin doses, or improper basal insulin adjustments, and subsequently provide actionable recommendations for providers. These insights are aimed at improving the quality of care and increasing accessibility to expert care for people with diabetes, especially in settings where endocrinologists are not readily available. Currently, the system is FDA-cleared to work with glucose data and doesn't require direct insulin data input, as it can infer insulin events from glucose trends. The company's platform is currently deployed in multiple health systems, including the Yale University health system and Boston Children's Hospital, with a focus on increasing its reach to primary care providers. Atlas indicated one key benefit of the platform is its ability to save providers significant time by automating documentation and visit summaries, which has already resulted in hundreds of hours saved in health systems. Looking forward, Atlas described how DreamMed Diabetes is expanding its offerings, including working on solutions for basal-only insulin patients and enhancing the platform's capabilities to include other diabetes therapies, such as GLP-1 medications. Atlas emphasized the company's mission to improve care access and outcomes, particularly in underserved populations. 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. Episode Highlights 0:00 Introduction and Background of DreaMed Diabetes 1:46 Current Functionality and Features of DreaMed Diabetes Platform 4:44 Algorithm Capabilities and Insights 7:06 Cloud-to-Cloud Integration and User Engagement 9:37 Onboarding Process and Data Analysis 21:00 Financial Benefits and Budget Neutrality 25:31 Future Enhancements and Broader Applications

Video Version only on HCPLive!  In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center explore the increasing focus on the connection between obesity and diabetes, including the latest advancements in glucagon-like peptide-1 (GLP-1) receptor agonist therapies, the use of inhaled insulin, and the recent addition of hypercortisolism to the “Ominous Octet”, creating the “Noxious Nine.” Although obesity rates in the US have been rising steadily globally, hosts pointed to a recent CDC report reporting a slight decrease in obesity rates. They suggest that this may be partially attributed to the impact of GLP-1 drugs, which have become increasingly popular in managing obesity and related metabolic disorders, including type 2 diabetes (T2D). With these drugs continuing to show promising results, the hosts express optimism about their potential to reduce obesity and improve long-term patient health outcomes. Their conversation shifted to a detailed discussion of the INHALE-1 trial, which evaluated the effectiveness of inhaled insulin in children with type 1 diabetes (T1D) and T2D. The trial, designed to evaluate the non-inferiority of inhaled insulin compared to traditional subcutaneous injections, found that inhaled insulin provided similar efficacy without significant differences in lung function or hypoglycemia occurrence. Isaacs and Bellini highlighted the implications of these findings, emphasizing that inhaled insulin could offer an alternative treatment option for pediatric patients, particularly those who struggle with needle phobia or the burden of multiple daily injections (MDIs). The episode concluded with a deep dive into the Catalyst study, which explored the use of mifepristone in patients with T2D complicated by hypercortisolism. The second phase of the Catalyst trial found a significant reduction in HbA1C levels, showing a 1.5% decrease in patients treated with mifepristone compared with the placebo group. Isaacs and Bellini discussed the potential clinical applications of these results, particularly for patients with difficult-to-control diabetes who may have an underlying hormonal issue contributing to their condition. Overall, hosts encouraged clinicians to consider hypercortisolism in their differential diagnosis for patients with challenging diabetes cases, noting the promise that mifepristone could offer as an adjunctive treatment. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Video Version Only on HCPLive! In this episode, 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, explore recent advancements in incretin-based therapies, highlighting their transformative potential for diabetes management and weight loss. The episode opens with a detailed discussion on Amgen's maridebart cafraglutide (MariTide; AMG-133), an investigational antibody peptide conjugate offering remarkable efficacy for obesity and overweight in Phase 2 trial data. At 52 weeks, participants without type 2 diabetes (T2D) experienced an average weight loss of ~20% with MariTide treatment without a weight loss plateau, while those with T2D achieved up to a ~17% average reduction without a plateau. The hosts underscored the potential impact of this type of therapy, particularly in addressing adherence challenges posed by the more frequent dosing schedules of current options. Hosts cited the potential safety concerns, but noted that AMG-133 could represent a significant step forward in managing obesity and related metabolic disorders. The conversation then shifted to a head-to-head comparison of two leading incretin therapies for obesity: tirzepatide (Zepbound) and semaglutide (Wegovy). Tirzepatide emerged as a frontrunner in the SURMOUNT-5 trial, contributing to a mean body weight reduction of 20.2% versus 13.7% achieved with semaglutide. Isaacs and Bellini discuss how these findings might influence clinical decision-making, emphasizing the importance of tailoring treatment plans to individual patient needs. They also touch on the practical implications of these therapies in both obesity and diabetes care, given the growing prevalence of these conditions. In the final segment, Isaacs and Bellini addressed a critical safety issue: the proliferation of non-FDA-approved compounded glucgaon-like peptide-1 (GLP-1) receptor agonists. The American Diabetes Association (ADA) released a statement warning against these unregulated formulations due to concerns over safety, quality control, and potential adverse effects. Despite the growing popularity of compounded versions as a lower-cost alternative, the hosts stressed the importance of prioritizing patient safety. They advised clinicians to steer patients toward evidence-based, FDA-approved therapies that have undergone rigorous testing and demonstrated consistent efficacy and safety profiles. 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.

Welcome to this special edition of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosted by 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. Included as part of the HCPLive This Year in Medicine series, this episode recaps headlines and practice updates related to continuous glucose monitoring (CGM) from the past year, with a focus on regulatory news from Medtronic, Dexcom, Abbott, and Senseonics. In recognition of the 25th anniversary of the first US Food and Drug Administration (FDA) approval of a CGM device in 1999, hosts also provide historic context for each company spotlighted during the episode. Medtronic To begin the episode, hosts start where the journey began: the FDA approval of the MiniMed in June 1999. In the 25 years since, MiniMed was acquired by Medtronic but has continued to remain among the leaders in CGM technology. During their conversation, hosts spend time discussing early experiences with CGM as well as newer advances from Medtronic, including the 2024 approval of the Simplera CGM. Dexcom Conversation around Dexcom ranges from the company's STS sensor in 2006 to the current G7 model as well as integration with pumps like the OmniPod 5, T:slim X2, and the Islet. When discussing news from 2024 from Dexcom, hosts call attention to the partnership with the Oura Ring and the launch of Stelo, the first FDA-approved over-the-counter CGM. Abbott Next, hosts dive into advancements from Abbott—starting with the Navigator and advancing to the Libre, including the Libre 3 plus, which features real-time data and 15-day wear. The hosts also celebrate Abbott's collaborations with Tidepool and major insulin pump manufacturers as well as the FDA clearance of the Lingo and Libre Rio. Senseonics The episode concludes with a discussion of Senseonics' Eversense CGM, the only FDA-approved implantable CGM. As the hosts highlight, Eversense has progressed over the years from a 90-day sensor to the groundbreaking 365-day wear system, which received approval in 2024. The hosts also highlight the potential of future developments, such as eliminating the external transmitter for a fully implantable design. Key Timestamps 00:00 - Start 01:37 - 25 Years of CGM 02:20 - Medtronic CGM History & Updates 05:01 - Dexcom CGM History & Updates 10:06 - Abbott CGM History & Updates 15:48 - Eversense CGM History & Updates

Video Version only on HCPLive! In celebration of the podcast surpassing 100 episodes, 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, sit down for a special edition episode with Irl Hirsch, MD, professor of medicine at the University of Washington. Discussion within the episode reflects on continuous glucose monitoring (CGM) and its revolutionary impact on diabetes care as well as its transformative history, beginning with its introduction by MiniMed in 1999. Hirsch recounts his first CGM experience and how it fundamentally changed his approach to managing hypoglycemia and diabetes complications. The conversation transitions to pivotal milestones, such as the JDRF CGM study and the push for Medicare coverage, which advanced CGM accessibility and integrated it into diabetes care standards. Hirsch also highlights the evolution of CGM technology, including the adoption of factory calibration, non-invasive sensors, and over-the-counter options, while addressing challenges like patient misconceptions about device accuracy. The trio also explore CGM's potential beyond glucose monitoring, including ketone detection, that could revolutionize diabetes management and broader healthcare applications. 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 Hirsch include Abbott Diabetes Care, Roche, Hagar, Tandem, and Mannkind. Chapters: 00:00 - Start 01:37 - Early Experiences with CGM 07:44 - Early Resistance and Advocacy  14:33 - Impact of CGM Advances 25:32 - Emerging Metrics and Biomarkers Beyond A1C 31:01 - Future Directions in Glucose Monitoring

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, take a deep dive into 3 pieces of news related to diabetes management and incretin therapies, including the BPROAD trial, tirzepatide in heart failure with preserved ejection fraction with obesity, and an NHANES analysis suggesting more than 50% of US adults qualify for semaglutide. BPROAD Presented at the American Heart Association (AHA) Annual Scientific Sessions 2024, BPROAD examined the effects of 120 mmHg vs 140 mmHg blood pressure goals among a cohort of 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. With a follow-up period lasting up to 5 years, the trial's primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Upon analysis, results suggested the mean SBP levels in participants at the 4-year visit were 120.6 mmHg in the intensive treatment group and 132.1 mmHg in the standard treatment group. Those receiving the intensive treatment regimen experienced a 21% lower relative risk of major cardiovascular events during the follow-up period, compared with those on standard treatment (HR 0.79; 95% Cl, 0.69 to 0.90; P

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, explore the recent updates surrounding GLP-1 receptor agonists, particularly focusing on long-term tirzepatide (Mounjaro/Zepbound) data and the current status of GLP-1 shortages. The hosts begin the episode by highlighting the FDA recently reported a stabilization in the GLP-1 supply, may reduce the use of compounded, unapproved versions of these drugs, which the FDA now cautions against in the absence of official shortages. Turning specifically to tirzepatide, the hosts discuss findings from the SURMOUNT-1 trial, now with a 3-year follow-up, which demonstrated sustained weight loss for doses up to 20% in patients with obesity. Additionally, tirzepatide showed a 94% reduction in progression from prediabetes to type 2 diabetes, which hosts highlight as a promising outcome given the increasing diabetes prevalence. The hosts anticipate further research that could reveal even longer-term benefits, especially as tirzepatide continues to show positive outcomes in sleep apnea and heart failure metrics. Isaacs and Bellini encourage clinicians to consider tirzepatide's sustained metabolic effects and urge a continued focus on personalized medicine as more data emerges. They conclude with a call to stay informed as GLP-1 research progresses, with the potential for further applications in chronic disease prevention and treatment. 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.

Launched on November 14, 2024 to celebrate World Diabetes Day, this episode tackles a flurry of recent news and updates related to semaglutide (Ozempic/Wegovy/Rybelsus), including Novo Nordisk declaring an end to the shortage of the drug, which began in early 2022. In the 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, discuss the latest developments in GLP-1 receptor agonists, with a particular focus on semaglutide. They begin by examining topline results from the SOUL trial, which demonstrated a 14% reduction in major adverse cardiovascular events with oral semaglutide (Rybelsus) in patients with established cardiovascular disease. According to hosts, this finding may expand options for patients who prefer oral medications over injections, although they emphasize proper administration techniques to maximize efficacy. The conversation then turns to new data presented at Obesity Week, showcasing oral semaglutide's effectiveness in weight loss for higher doses—25 and 50 mg—demonstrating 14% weight loss at 25 mg. They also highlight semaglutide's impact in specific comorbidities in recent trials, with use eliciting a significant reduction in osteoarthritis pain and potential benefits for kidney disease, even in patients without diabetes. Isaacs and Bellini discuss the SELECT trial results, where semaglutide showed a reduced rate of hospitalizations and adverse events, suggesting an anti-inflammatory benefit that could further support its use in managing obesity and type 2 diabetes. The episode concludes with a call to payers to support wider coverage, given the compelling data on reduced hospitalization and improved patient outcomes. 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.

This episode spotlights news in diabetes technology from the latter half of October 2024. In the episode, hosts breakdown updates from multiple companies related to continuous glucose monitoring and insulin delivery. A brief overview of announcements covered in the episode by 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, can be found below: Abbott's FreeStyle Libre 3: On October 30, 2024, Beta Bionics Inc announced the integration of the iLet Bionic Pancreas with Abbott's FreeStyle Libre 3 Plus sensor. According to hosts, the new compatibility broadens choice for patients and offering flexibility in CGM usage. Additionally, this sensor has also been approved for use during MRI and CT scans, eliminating the need to remove the device, which adds convenience for patients requiring frequent imaging. Integration with Tidepool: On October 28, 2024, Tidepool announced a new data integration with Abbott. With this integration, the Libre 3 now connects with Tidepool, allowing data from multiple CGMs to be consolidated in a single platform, streamlining data review for clinicians and patients and reducing training requirements. Omnipod 5 for iOS: on October 29, 2024, Insulet Corporation announced the full market release of its Omnipod 5 App for iPhones in the US. Now available for iPhone users (using Dexcom G6), the update allows features like preset meal settings, a valuable tool for patients who use flexible carb counting approaches. 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.

On September 17, 2024, Ascensia Diabetes Care and Senseonics announced the US Food and Drug Administration's (FDA) clearance of the Eversense 365 system for people with type 1 and type 2 diabetes aged 18 years or older—the world's first 1-year continuous glucose monitor (CGM). A fully implantable, long-term CGM option, the Eversense 365 offers a 12-month sensor survivability and implantable sensor, which allow for fewer data interruptions, less waste, and lessened burden on quality of life, according to the release from Ascensia and Senseonics. Other features highlighted by the companies include a silicone-based adhesive that can be changed daily, a removable transmitter that can be taken on and off without wasting a sensor or adding a warmup period, and on-body vibration alerts to keep patients notified when away from their phone. Ascensia and Senseonics also pointed out Eversense 365 had been cleared as an integrated CGM system, which allows for integration with compatible medical devices, including insulin pumps as part of an automated insulin delivery system. “Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, president of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics' ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.” In this special edition of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Hansen joins 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, for a deep dive into the Eversense 365 and what clearance means for people with diabetes. During the episode, key points of discussion include the product's features like reduced calibrations, the convenience of the transmitter's USB charging, and its suitability for active patients. During the discussion, Hansen emphasizes the role of patient choice in design and future direction for Eversense. Hansen notes Eversense is currently working to expand inserter networks and pursue pump partnerships, with future goals to include a fully implantable sensor without a transmitter. 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: Campbell P. FDA clears Eversense 365, marking First 1-year CGM option in diabetes. HCP Live. September 18, 2024. Accessed October 15, 2024. https://www.hcplive.com/view/fda-clears-eversense-365-marking-first-1-year-cgm-option-in-diabetes. Senseonics. Eversense 365 receives FDA Clearance: The World's first one year CGM. Senseonics. September 17, 2024. Accessed October 15, 2024. https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174. Key Timestamps and Highlights 00:00 - Introduction and Guest Introduction 02:04 - Overview of Eversense 365 07:20 - Details on the Transmitter 08:44 - Patient Candidate and Use Cases 13:55 - Medicare Coverage and Integration with Insulin Pumps 17:01 - Future Goals and Patient Choice 28:38 - App and Remote Patient Monitoring

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss US availability of the Abbott Lingo and Embecta's announcement of US Food and Drug Administration (FDA) clearance for their tubeless patch pump with a 300-unit insulin reservoir. Abbott Lingo Availability On September 05, 2024, Abbott announced US availability of their over-the-counter continuous glucose monitoring system, the Lingo. Designed for consumers 18 years and older not on insulin, is priced at $49 for 1 biosensor worn for up to 14 days or $89 for 2 biosensors. The announcement of availability comes less than 2 weeks after Dexcom announced the availability of the Stelo and less than 3 months after Abbott announced the FDA clearance of the Rio and Lingo systems. Editor's note: During this episode, hosts reference a 15-day wear time for this system, the Lingo can be worn for up to 14 days, according to Abbott. Embecta Approval On September 03, 2024, Embecta Corporation announced the US FDA had granted 510(k) clearance for their disposable patch pump for insulin delivery for use in adults who require insulin to manage diabetes. Including both 1 and type 2 diabetes within this indication, the FDA clearance means patients will have access to a tubeless patch pup boasting a 300-unit insulin reservoir designed based on feedback from people with type 2 diabetes and healthcare providers. According to the company, the 300-unit insulin reservoir will offer a distinct advantage compared to other systems, citing a recent study finding a reservoir of this size would meet the needs of 64% of adults with T2D for three-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population. In their announcement, Embecta pointed out patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, take a deep dive into their experience with the Dexcom Stelo. The Dexcom Stelo is the first FDA-cleared over-the-counter glucose sensor. Cleared by the FDA on March 05, 2024, the Stelo is indicated for use by anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Dexcom announced availability of the device via Stelo.com on August 26, 2024. In a previous episode, Isaacs an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Bellini, provide insight to their experiences with the system after the first 24 hours of use. In this episode, describe their continual experience with the device itself as well as the app. During the episode, hosts discuss the app setup process, which differentiates between users with and without diabetes, setting appropriate target glucose ranges. Later, the hosts praise the app's educational "nuggets" and the spike detection feature, which prompts users to reflect on potential causes of glucose changes. Bellini notes her appreciation of the app's ability to ask questions about real-time glucose fluctuations, highlighting how this could provide valuable insights to consumers, and Isaacs calls attention to the app's 15-minute data updates, though the underlying data is available every 5 minutes. Later in the episode, hosts discuss some of the early drawbacks of the system. 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.

This episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, our second related to the Association of Diabetes Care and Education Specialists (ADCES) 2024 annual meeting, spotlights new data and perspectives from the meeting brought forth by pharmaceutical and diabetes technology companies. Check out our first episode related to ADCES 2024. A large theme of the episode is discussion around data and interactions with Lexicon, which announced the resubmission of a New Drug Application for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control among adults with type 1 diabetes and chronic kidney disease. According to the FDA, the agency considers the resubmission a complete response to its 2019 letter regarding sotagliflozin for type 1 diabetes.1 For this application, the FDA has assigned a Prescription Drug User Fee Act review date of December 20, 2024. On August 21, 2024, Lexicon Pharmaceuticals announced the FDA's intention to host an advisory board meeting regarding this application.2 Of note, sotagliflozin (Inpefa) has received approval in heart failure for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors in May 2023.3 Following this, the conversation between 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, shifts to a discussion on Medtronic's collaboration with Abbott, with the hosts praising this partnership as a strategic move to improve sensor technology for patients. The episode then highlights the innovative educational approach to learning about the Sequel Twiist, with Sequel hosting a jeopardy-style game to engage attendees in learning about their upcoming pump product. Finally, the hosts explore the Diabetotech certificate program, which offers in-depth education on various diabetes technologies, and emphasize the importance of continuous learning and unbiased educational resources in the rapidly evolving field of diabetes management. 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.

On August 15, 2024, the Biden-Harris Administration announced the price list for the first 10 drugs selected as part of the Medicare price negotiations between the United States Department of Health and Human Services (HHS) and pharmaceutical manufacturers. “Americans pay too much for their prescription drugs. That makes today's announcement historic. For the first time ever, Medicare negotiated directly with drug companies and the American people are better off for it,” said HHS Secretary Xavier Becerra. Part of the Inflation Reduction Act, the announcement of intended pricing for these agents comes nearly a year after the Centers for Medicare and Medicaid Services (CMS) announced the list of the first 10 agents included in the negotiations. The list, which consists of the 10 drugs with the highest gross annual spending total, accounts for $50.5 billion in total Part D gross covered prescription costs per year and more than $3.4 billion in out-of-pocket costs Among the first 10 agents chosen, 4 have specific indications for patient populations with diabetes: empagliflozin, sitagliptin, dapagliflozin, and Novo Nordisk-specific insulin aspart products. According to CMS statistics, these 4 agents accounted for more than $16 billion in total Part D spending from June 1, 2022 through May 31, 2023. These prices will come into effect starting January 1, 2026. As part of the Inflation Reduction Act, CMS will select up to 15 more drugs covered under Part D for negotiation in 2027, up to 15 more drugs in 2028, including drugs covered under Part B and Part D, and up to 20 more drugs for each year after. A follow-up to their reaction episode earlier this year, this episode examines the price changes and what this could translate to for those with diabetes or members of the care team. In the episode, hosts discuss how significant reductions in the prices of SGLT2 inhibitors and insulin products will benefit people with diabetes, but point out the absence of long-acting insulin and GLP-1 agonists from the initial list is notable and will require continued negotiations. Video Version: https://www.hcplive.com/view/diabetes-dialogue-first-10-prices-announced-from-cms-price-negotiations

The Association of Diabetes Care and Education Specialists (ADCES) is an organization ahead of its time in the world of healthcare. Often, those in medicine find the field to be reactionary instead of proactive in addressing the rising burden of chronic disease. The ADCES, formerly the American Association of Diabetes Educators, was founded in 1973 to support and educate clinicians, care providers, and patients of the latest advancements to improve care and quality of life for people with diabetes. This mission, while important in the 1970s, has become crucial if health systems hope to combat a burgeoning diabetes crisis. In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, we celebrate the ADCES 2024 annual meeting through the perspective of 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. The first of 2 scheduled episodes related to the meeting, this episode focuses on presentations and sessions Isaacs and Bellini were directly involved in from the meeting. Key topics include the challenges of using insulin pumps for type 2 diabetes, the role of DME companies in accessing CGM for people with Medicare, and the latest research on automated insulin delivery systems during pregnancy. The hosts also discuss interpreting ambulatory glucose profiles and time-in-range targets. Throughout the conversation, Isaacs and Bellini share their enthusiasm for the advancements in diabetes technology and the importance of effective patient education and counseling. Video Version: https://www.hcplive.com/view/diabetes-dialogue-navigating-adces-2024 

In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP,  welcome Muthiah Vaduganathan, MD, MPH, cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women's Hospital, for a discussion around topline data updates from the SUMMIT and FINEARTS-HF trials, the latter of which Vaduganathan served on as a trial investigator. Video Version: https://www.hcplive.com/view/diabetes-dialogue-summit-and-finearts-hf-with-muthiah-vaduganathan-md-mph SUMMIT On August 01, 2024, Eli Lilly and Company announced topline data from the SUMMIT trial, which examined use of tirzepatide (Mounjaro; Zepbound) 5mg, 10 mg, or 15 mg in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The first primary endpoint of SUMMIT a composite endpoint of time-to-first occurrence of urgent heart failure visit, heart failure hospitalization, oral diuretic intensification and cardiovascular death to study completion and the second primary endpoint was change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to week 52. According to the announcement, results of the study indicate use of the dual GIP/GLP-1 receptor agonist was associated with statistically significant improvements in both primary endpoints, with a 38% relative risk reduction in time-to-first occurrence of heart failure outcomes relative to placebo therapy over 104 weeks of follow-up. Results also pointed to a statistically significant benefit on change from baseline in KCCQ-CSS (24.8 vs 15.0). FINEARTS-HF Less than a week later, on August 05, 2024, Bayer announced results from the phase 3 trial of their nonsteroidal mineralocorticoid receptor antagonist, finerenone (Kerendia), among patients with heart failure with mildly reduced or preserved ejection fraction. According to Bayer, FINEARTS-HF met its primary endpoint, with achieving a statistically significant reduction of the composite of cardiovascular death and total heart failure events relative to placebo therapy. The trial is due to be presented in a Hot Line session at the upcoming European Society of Cardiology Congress and Bayer plans to discuss the data and submission for regulatory approval with the US Food and Drug Administration. 

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, take a break from the Annual Conference of the Association of Diabetes Care and Education Specialists to discuss the latest news from Medtronic and what it means for practitioners as well as patients with diabetes. Video Version: https://www.hcplive.com/view/diabetes-dialogue-simplera-cgm-and-medtronic-partnership-with-abbott 

Even with the second half of the trial yet to be completed, results of the CATALYST trial have initiated a potentially seismic shift in discussions around the management of type 2 diabetes. With the first part of the trial suggesting approximately 1-in-4 patients with difficult-to-control type 2 diabetes, results suggest hypercortisolism could be an underlying driver of suboptimal disease management for millions of people with type 2 diabetes in the US. Now, with this knowledge in hand, the community waits with bated breath for Corcept Therapeutics' announcement of results from the second half of the trial, which assessed the use of mifepristone (Korlym) by randomizing patients who were diagnosed with hypercortisolism in a 2:1 ratio to mifepristone or placebo therapy. Principal investigator John Buse, MD, PhD, chief of the Division of Endocrinology and the director of the University of North Carolina's Diabetes Care Center, Buse and fellow investigators presented full data from the first half of the prevalence trial at the 84th American Diabetes Association Scientific Sessions The first half of CATALYST was designed to assess the prevalence of hypercortisolism among 1000 patients from 36 study sites. For inclusion in the study, patients needed to have an HbA1c greater than 7.5% despite receiving optimal therapies. Of note, the trial defined optimal therapies for type 2 diabetes as 3 or more antihyperglycemic agents or 2 or taking insulin and other antihyperglycemic agents. Once identified, participants were required to complete a dexamethasone suppression test. If the values from this test were greater than 1.8 µg/dL and dexamethasone levels were greater than 140 ng/dL, these patients were considered as having hypercortisolism. Results indicated the prevalence of hypercortisolism among patients with difficult-to-control type 2 diabetes was 24% (n=253 of 1055; 95% CI, 21.4 to 26.7). Buse highlighted 35.4% of those with hypercortisolism were taking 3 or more antihypertensive medications and were more likely to have cardiovascular risk relative to those without hypercortisolism. In this episode, Buse joins hosts to discuss the trial background, expected prevalence, reaction to results, and the importance of the second part of the trial as the community moves into the future with knowledge of the true prevalence of hypercortisolism in difficult-to-control type 2 diabetes. Chapters 00:00 - Introduction and background on Dr. John Buse and his practice 01:08 - Overview of the CATALYST trial 02:09 - Surprising results from the screening phase 07:36 - Characteristics of patients who tested positive 12:36 - Implications for clinical practice and potential changes to screening guidelines 15:52 - Hypothesized benefits of mifepristone treatment and plans for presenting the results

Less than a month after rebranding from JDRF to Breakthrough T1D, the leading type 1 diabetes advocacy organization has now released new consensus guidance related to the monitoring of early-stage type 1 diabetes. Debuted on the final day of the 84th American Diabetes Association Scientific Sessions, the consensus document seeks to fill a gap in guidance around autoantibody-positive individuals in early-stage type 1 diabetes as the community develops new means to delay or prevent progression of the disease. Proof of the document's significance, it has received endorsement from both the ADA and the European Association for the Study of Diabetes, with simultaneous publication in Diabetes Care and Diabetologia. “We are experiencing a paradigm shift in type 1 diabetes care, and we can now identify people in the earlier, presymptomatic stages of type 1 diabetes, before insulin is required, and intervene,” said Anastasia Albanese-O'Neill, PhD, APRN, associate vice president of Breakthrough T1D. “Until now, there was no consensus on how to care for these individuals in the clinical setting and provide appropriate education and psychological support. This new guidance should be used widely by healthcare providers to inform and guide the care of individuals in early stage T1D.” Presented in a special symposium dedicated to the new consensus guidance, the document clocks in at 29 pages in length and cites more than 170 references. Included within the guidance are specific sections dedicated to monitoring among children and adolescents, adult patients, and pregnant patients. Beyond guidance on monitoring, the document also dedicates space to outlining updated terminology on type 1 diabetes staging and how to provide psychosocial and educational support for affected individuals and families. To learn more about this new guidance and discuss the future of type 1 diabetes, hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, Diana Isaacs, PharmD, and Natalie Bellini, DNP, sat down with Albanese-O'Neill at ADA 2024. During their conversation, hosts discuss the recent name change to Breakthrough T1D, the growing prevalence of adults being diagnosed with type 1 diabetes, and major takeaways from the consensus guidance.

At the 84th American Diabetes Association (ADA) Scientific Sessions, INHALE-3 was among the trials to take center stage. A phase 4 trial comparing the use of inhaled insulin (Afrezza) against standard care, results demonstrated use of inhaled insulin, in addition to insulin degludec, was associated with improved HbA1c in patients with type 1 diabetes, with an improvement of 0.5% or greater observed among 21% of those on inhaled insulin and 5% of those with usual care. At the meeting, study investigator Grazia Aleppo, MD, professor of Medicine and director of the Diabetes Center at Northwestern University, joined hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, for a discussion on the trial, results, considerations for practicing clinicians, and next steps for research. In the latter portion of the episode, Aleppo, who serves on the guideline writing committee for the ADA Standards of Care discusses recent updates in diabetes technology. Chapters 00:47 - Intro 01:15 - INHALE-3 08:00 - Reasons for Participating 10:40 - Results in AID Users 17:01 - Updates in Diabetes Technology

Despite being a chronic autoimmune disease, the burden of type 1 diabetes is often overlooked in public health discussions. Not only are patients with type 1 diabetes being tasked with understanding disease pathophysiology as an integral part of optimal management, but also with keeping up with advances in pharmacotherapy and technology. As a result, patient support programs, such as Blue Circle Health, have emerged to fill a vital role in the management teams for people with diabetes. Provided at no cost to patients through funding from the Helmsley Charitable Trust, the program is designed to free education and support programs in the form of a diabetes support coach, insurance navigation, peer coaching, and special programs, including programs dedicated to introducing patients to continuous glucose monitoring. The program is currently limited to adults with type 1 diabetes living in Florida but has disclosed plans for introduction into additional states. Patients are required to meet the following characteristics to participate: Be diagnosed with Type 1 Diabetes Be 18 years or older Speak English and/or Spanish Have access to the internet and a smart phone or computer to do video calls with the care team Have a primary care provider or are willing to be connected to one Are not currently pregnant As part of their on-site presence at the 84th American Diabetes Association Scientific Sessions, 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, invited Monica Gomberg, MD, Vice President, Clinical Care at Blue Circle Health, to take part in this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives.

In this special edition episode from the 84th American Diabetes Association Scientific Sessions, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Davida Kruger, NP, a certified nurse practitioner in the Division of Endocrinology at Henry Ford Health System in Detroit. During the episode, Kruger takes hosts on a deep dive into the latest in diabetes technology at the meeting, with a focus on advancement in automated insulin delivery and continuous glucose monitoring (CGM) technology. In the early half of the episode, Kruger discusses the results of the SECURE-T2D trial, which examined use of the Omnipod 5 in patients with type 2 diabetes using insulin, and, later in the episode, Kruger offers her perspective on the age of over-the-counter CGM in the wake of announcements from Dexcom and Abbott earlier this year. Video Version: https://www.hcplive.com/view/diabetes-dialogue-advances-in-aid-and-cgm-at-ada-2024-with-davida-kruger-np 

On the opening day of the 84th American Diabetes Association Scientific Sessions, the ADA ushered in a new era for their organization with the announcement of the formation of the Obesity Association. Created more than a decade after the American Medical Association recognized obesity as a disease, the new subdivision of the ADA was created to further the organization's mission of advocating for and advancing treatment for patients. According to a news release, the ADA intends to develop a Standards of Care for Obesity and to leverage education, advocacy and evidence-based support to reduce barriers to optimal care for people affected by diabetes for people with and without diabetes. As part of the on-site coverage of ADA 2024, Diana Isaacs, PharmD, and Natalie Bellini, DNP, hosts sat down with Robert Gabbay, MD, PhD, the chief scientific and medical officer of the ADA, for more insight into the newly formed Obesity Association, future plans, and how this move reflects the changing landscape of metabolic health.

In this special edition recorded at the 84th American Diabetes Association Scientific Sessions, Carol Levy, MD, director of the Mount Sinai Diabetes Center and Type 1 Diabetes Clinical Research, joins the podcast for a deep dive into the INHALE-3 trial and how to incorporate individual patient-level factors into the management strategy of patients with type 1 diabetes who could benefit from inhaled insulin (Afrezza). Their second on-site episode focused on the INHALE-3 trial, 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, begin the conversation by focusing on the differences in safety and efficacy observed with use of inhaled insulin seen among those using automated insulin delivery systems relative to their counterparts using multiple daily injections. Later in the episode, the focus of discussion shifts to the potential of inhaled insulin in optimizing diabetes management among pregnant patients with type 1 diabetes.

This special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives focuses on top highlights and updates in diabetes technology from the 84th American Diabetes Association Scientific Sessions. In the episode, hosts Omnipod 5 and the SECURE-T2D trial, a study comparing use of simplified meal announcement vs precise carbohydrate counting with the Medtronic MiniMed 780G, and real-world data from Tandem pump users. Later in the episode, hosts discuss their experience on the conference floor getting hands-on interactions with soon to come or recently released diabetes technology showcased at the meeting, including the Sequel Twiist, Abbott's Libre 3 Plus, and ketone monitors. Episode Chapters 00:00 - Intro 00:37 - Episode Start 01:05 - SECURE-T2D 05:50 - Medtronic Data 08:40 - Tandem Data 16:40 - Forthcoming Diabetes Technology 17:45 - Sequel Twiist 20:45 - Libre 3 Plus 24:00 - OTC CGM 25:00 - Dexcom Upgrades 29:15 - Ketone Monitors

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a June 2024 update focusing on a trio of topics across the spectrum of diabetes management. In the episode, hosts discuss the US Food and Drug Administration clearance of 2 new over-the-counter continuous glucose monitoring systems from Abbott, the renaming of JDRF to Breakthrough T1D, and the FDA clearance of the CamAPS FX for people with type 1 diabetes. Chapters:  00:00 - Intro 00:40 - Abbott OTC CGM 06:20 - Diabetes Technology Pipeline 10:45 - JDRF Rebrands as Breakthrough T1D 15:15 -  US FDA Clearance of CamAPS FX

In this episode, hosts provide their audience with an overview of a pair of new studies on the topic of diabetes in pregnancy: the GLAM and CRISTAL studies.

To celebrate the FLOW trial and break down what it means for people with type 2 diabetes and CKD, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, recorded a special edition episode to discuss the clinical application of this trial, unmet need in CKD management, the future of incretin therapies, and more! Chapters: 00:00 - Intro  00:40 - FLOW Background 02:55 - FLOW Results 07:08 - Combination with SGLT2 Inhibitors 12:00 - Future Implications

The American College of Physicians has released new recommendations in favor of SGLT2i and GLP-1 RA and against the use of DPP-4i as second-line therapies to metformin in adults with type 2 diabetes and inadequate glycemic control. Released on the first day of the ACP's Internal Medicine Meeting 2024, the pair of recommendations reflect the findings from a systematic review and network meta-analysis and cost-effectiveness analysis assessing the value of these therapies as both monotherapies and in combination with metformin. Attendees at this year's meeting, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the ACP's latest recommendations in a special ACP 2024 edition of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives. Video Version: https://www.hcplive.com/view/diabetes-dialogue-2024-acp-type-2-diabetes-recommendations

In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, tackle a pair of related topics: what the STEP HFpEF DM trial from ACC.24 means for the diabetes community and the need for fair and equitable allocation of incretin-based therapies in the face of ongoing drug shortages and overwhelming demand.

The diabetes community welcomed an additional tool to the armamentarium with the US Food and Drug Administration's clearance of the twiist automated insulin delivery (AID) system on March 18, 2024. Cleared for use in patients aged 6 years and older with type 1 diabetes, the twiist, which is marketed by Sequel Med Tech, is billed as the first drug delivery system that directly measures volume and flow of inulin delivered with every micro-dose. In this episode, Alan Lotvin, MD, co-founder and CEO of Sequel Med Tech, offers hosts a deep dive into the latest AID to receive approval, including the pump's patient-centric design, why they chose to leverage the Tidepool Loop algorithm, plans for device launch, and more. Chapters   00:00 - Start 01:00 - Lotvin Introduction 03:25 - Differences from Current AIDs 08:15 - Compatible CGMs 10:25 - Plans for Launch 12:05 - Design Discussion 16:50 - iPhone vs Android Compatibility 19:50 - Clinical Trials 22:20 - Tidepool Loop Algorithm 27:45 - Accuracy of Current Pumps