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

Diabetes Dialogue: Semaglutide for MASH in ESSENCE Trial, With Arun Sanyal, MD

Play Episode Listen Later Apr 30, 2025 25:35

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

Diabetes Dialogue: CATALYST Reveals High Prevalence of Hypercortisolism in T2D

Play Episode Listen Later Apr 29, 2025 12:04

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

Diabetes Dialogue: Oral GLP-1 Orforglipron in ACHIEVE-1 Trial

Play Episode Listen Later Apr 24, 2025 10:30

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

Diabetes Dialogue: Screening for Presymptomatic T1D with Rifka Schulman-Rosenbaum, MD

Play Episode Listen Later Apr 15, 2025 20:27

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

Diabetes Dialogue: SOUL and STRIDE Trials from ACC 2025

Play Episode Listen Later Apr 9, 2025 16:59

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.”

Diabetes Dialogue: Updates and News from ATTD 2025 Part 1

Play Episode Listen Later Apr 4, 2025 25:59

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.

Diabetes Dialogue: Understanding Control-IQ+ AID Algorithm with Laurel Messer, PhD, RN

Play Episode Listen Later Mar 18, 2025 30:28

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.

Omnipod 5 and Medtronic 780G for Type 2 Diabetes

Play Episode Listen Later Feb 15, 2025 14:58

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

Diabetes Dialogue: ADA's 2025 Standards of Care in Diabetes Therapeutics

Play Episode Listen Later Jan 23, 2025 23:27

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

Diabetes Dialogue: ADA's 2025 Standards of Care in Diabetes Technology

Play Episode Listen Later Jan 16, 2025 26:07

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

The Evolving Role of Registered Dietitian Nutritionists in Obesity

Play Episode Listen Later Jan 13, 2025 28:26

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

Diabetes Dialogue: Leveraging Smart Algorithms for Insulin Optimization with Eran Atlas

Play Episode Listen Later Jan 6, 2025 27:19

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

Diabetes Dialogue: Insights on INHALE-1 and CATALYST Trials

Play Episode Listen Later Jan 2, 2025 15:40

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.

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Diabetes Dialogue: Exploring New Horizons in Incretin Therapy for Diabetes and Weight Loss

Play Episode Listen Later Dec 22, 2024 22:57

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.

Diabetes Dialogue: Celebrating 2024 - The Year of the Continuous Glucose Monitor

Play Episode Listen Later Dec 16, 2024 18:24

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

Celebrating 25 Years of CGM, with Irl Hirsch, MD

Play Episode Listen Later Dec 15, 2024 36:02

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

News and Updates in Diabetes at AHA 2024

Play Episode Listen Later Nov 21, 2024 23:05

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

Tirzepatide's Long-Term Obesity Data

Play Episode Listen Later Nov 14, 2024 11:45

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.

Latest Updates on Semaglutide

Play Episode Listen Later Nov 14, 2024 24:32

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.

Diabetes Tech Updates in October 2024

Play Episode Listen Later Nov 11, 2024 18:56

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.

What to Know About the Eversense 365 CGM, with Brian Hansen

Play Episode Listen Later Oct 16, 2024 34:08

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

Lingo Availability & Embecta's Tubeless Patch Pump

Play Episode Listen Later Sep 11, 2024 11:48

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.

Real-World Experience with Dexcom Stelo

Play Episode Listen Later Sep 11, 2024 11:34

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.

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Sotagliflozin for T1D and Other ADCES Highlights

Play Episode Listen Later Aug 21, 2024 20:58

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.

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First 10 Prices Announced from CMS Price Negotiations

Play Episode Listen Later Aug 19, 2024 7:57

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

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Navigating ADCES 2024

Play Episode Listen Later Aug 19, 2024 25:15

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

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SUMMIT and FINEARTS-HF, with Muthiah Vaduganathan, MD, MPH

Play Episode Listen Later Aug 10, 2024 22:41

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.

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Simplera CGM and Medtronic's Partnership with Abbott

Play Episode Listen Later Aug 10, 2024 14:20

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

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CATALYST Trial and Hypercortisolism in T2D, with John Buse, MD, PhD

Play Episode Listen Later Aug 2, 2024 23:55

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

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New Early-Stage T1D Monitoring Guidance, with Anastasia Albanese-O'Neill, PhD, APRN

Play Episode Listen Later Jul 18, 2024 21:23

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.

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INHALE-3 and Diabetes Tech Updates, with Grazia Aleppo, MD

Play Episode Listen Later Jul 18, 2024 24:58

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

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Blue Circle Health, with Monica Gomberg, MD

Play Episode Listen Later Jul 18, 2024 18:16

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.

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Advances in AID and CGM at ADA 2024, with Davida Kruger, NP

Play Episode Listen Later Jul 18, 2024 23:48

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

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ADA Introduces Obesity Association, with Robert Gabbay, MD, PhD

Play Episode Listen Later Jul 18, 2024 12:04

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.

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Patient Considerations for Inhaled Insulin, with Carol Levy, MD

Play Episode Listen Later Jul 18, 2024 18:11

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.

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ADA 2024 Diabetes Technology Recap

Play Episode Listen Later Jul 18, 2024 32:11

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

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June 2024 Updates in Diabetes Technology and T1D

Play Episode Listen Later Jun 17, 2024 24:16

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

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GLAM and CRISTAL, Updates in Pregnancy

Play Episode Listen Later Jun 5, 2024 21:09

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.

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FLOW Trial and Semaglutide's Benefit in Chronic Kidney Disease

Play Episode Listen Later May 31, 2024 13:32

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

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2024 ACP Type 2 Diabetes Recommendations

Play Episode Listen Later Apr 20, 2024 23:31

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

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STEP HFpEF DM and Fair Allocation of Incretin-Based Therapies

Play Episode Listen Later Apr 20, 2024 23:31

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.

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What to Know about Sequel Med Tech's twiist AID System, with Alan Lotvin, MD

Play Episode Listen Later Mar 30, 2024 31:29

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

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Hot Topics and Updates from ATTD 2024

Play Episode Listen Later Mar 30, 2024 20:40

In the third and final recap episode from the 17th annual International Conference on Advanced Technologies & Treatments for Diabetes, hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives Diana Isaacs, PharmD, and Natalie Bellini, DNP, take a deep dive into a series of topics from the meeting, including GLP-1 receptor agonist use and CGM technology, updates in once-weekly insulins, the concept of continuous ketone monitoring, and application of artificial intelligence into care. Video version: https://www.hcplive.com/view/diabetes-dialogue-hot-topics-and-updates-from-attd-2024

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T1D Glycemic Improvement and CRISTAL at ATTD 2024

Play Episode Listen Later Mar 26, 2024 8:29

In this episode, hosts provide insight from automated insulin delivery updates from the 17th annual International Conference on Advanced Technologies & Treatments for Diabetes. The specific topics of note covered in this study include new data related to diabetes technology use from the Type 1 Diabetes (T1D) Exchange and a read-out of data from the CRISTAL trial.

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FLOW Trial and Chronic Kidney Disease Updates, with Brendon Neuen, MBBS, PhD

Play Episode Listen Later Mar 22, 2024 29:52

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives hosts are joined by Brendon Neuen, MBBS, PhD, nephrologist and director of the Kidney Trials Unit at Royal North Shore Hospital and senior research fellow at The George Institute for Global Health. During the episode, Neuen talks about the FLOW trial, topline results, how the rapid advancement in pharmacotherapies has altered conversations around management, the concept of 4 pillars of GDMT for CKD in type 2 diabetes, and how to approach sequencing of these therapies. Video Version: https://www.hcplive.com/view/diabetes-dialogue-flow-trial-and-chronic-kidney-disease-updates-with-brendon-neuen-mbbs-phd Episode Highlights 00:32 - Neuen Introduction 01:55 - FLOW Trial 05:15 - Pillars of CKD Therapy 16:15 - Need for New Guidelines 21:15 - Barriers to Uptake 24:50 - Need for Screening

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Dexcom Stelo and CGM Updates, with Jake Leach

Play Episode Listen Later Mar 22, 2024 28:26

Hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives recorded a special edition episode with Jake Leach, chief operating officer of Dexcom. The episode itself represents a follow-up to a conversation a year ago at International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2023, where Leach discussed the ongoing global rollout of the Dexcom G7 and how he expected expanded coverage of the device to open doors to greater personalization of care for people with diabetes. In the current episode, Leach and hosts touch upon the Stelo clearance, its accuracy relative to other CGM devices, plans for rollout and pricing, the importance of increased accessibility of CGM technology, and the push for greater accuracy in glucose monitoring devices. Video Version: https://www.hcplive.com/view/diabetes-dialogue-stelo-news-and-dexcom-cgm-updates-with-jake-leach Episode Highlights 00:30 - Jake Leach Introduction 01:20 - Dexcom Stelo Overview 06:25 - Differences vs G6 and G7 14:45 - Direct to Watch Technology 20:05 - Future of Dexcom Portfolio

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Tirzepatide and the Future of Incretin Therapies, with Timothy Garvey, MD

Play Episode Listen Later Mar 18, 2024 24:52

W. Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham and the principal investigator of SURMOUNT-2, joins our hosts to provide perspective on several topics, including the FDA's approval of tirzepatide for chronic weight management, data from the SURMOUNT-2, -3, and 4 programs, the future of incretin therapies, and more. Key Timestamps 01:04 - Guest Introduction 03:45 - FDA Indication for Obesity 08:45 - SURMOUNT-2 17:40 - SURMOUNT-3 and -4 22:00 - Future of Incretin Therapies

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SELECT, Semaglutide, & the Future of Incretin Therapies, with A. Michael Lincoff, MD

Play Episode Listen Later Mar 2, 2024 24:40

In this episode, hosts are joined by co-chair of the SELECT steering committee A. Michael Lincoff, MD, to discuss results, potential explanations for cardiovascular benefit of semaglutide 2.4 mg beyond weight reduction, FLOW trials implications, and the future of incretin therapies. Chapters: 00:35 - Guest Introduction 01:10 - SELECT Results Overview 04:25 - Next Steps for Research 07:15 - Mechanism of Action for CV Benefit 09:00 - FLOW Trial Implications 11:25 - Impact on Access 15:00 - Future of Incretin Therapies 21:45 - Predicting the Next 5-10 Years for Semaglutide

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Understanding MARD, Comparing Popular CGM Sensors

Play Episode Listen Later Feb 29, 2024 21:43

In this episode, the hosts breakdown a pair of recent publications related to better understanding the strengths and limitations of MARD as well as a study comparing the Dexcom G7 and FreeStyle Libre 3 sensors. Video version: https://www.hcplive.com/view/diabetes-dialogue-understanding-mard-comparing-popular-cgm-sensors Key Highlights: 00:35 - The Myth of MARD 04:10 - Considerations When Interpreting MARD 10:15 - FreeStyle Libre 3 vs. Dexcom G7

ATTD 2024 Preview

Play Episode Listen Later Feb 26, 2024 14:33

In the episode, hosts provide insight into sessions to watch, device news they are excited for, what makes ATTD a unique and valuable experience for the diabetes care team, and how the meeting's annual yearbook session encapsulates the exciting developments within the field. Video Version: https://www.hcplive.com/view/diabetes-dialogue-attd-2024-preview Key Highlights: 01:05 - Bellini's ATTD Picks 03:45 - Isaacs' ATTD Picks 06:20 - Health Disparities in Focus 07:10 - Time in Tighter Range 10:20 - Insulin Users with T2D 11:15 - ATTD Yearbook Session

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Time in Range, CGM Metrics for Predicting Outcomes in Diabetes

Play Episode Listen Later Feb 20, 2024 15:14

The introduction of CGM in 1999 completely shifted the trajectory of care for people with diabetes. Now, new data suggest advanced CGM metrics, such as time in range, are proving comparable to HbA1c for predicting diabetic retinopathy and other microvascular outcomes. In this episode, Viral Shah, MD, joins Diabetes Dialogue to discuss a recent study examining associations between time in range and other advanced CGM metrics with diabetic retinopathy and the implications for use in predicting other microvascular outcomes. Episode Highlights 00:05 - Intro 02:04 - CGM Data to Predict Diabetes Complications 05:15 - Time in Range and Microvascular Complications 09:36 - Glycemic Variability and Incident Diabetic Retinopathy 12:17 - Time in Range, CGM Data for Predicting CV Outcomes

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