Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCE

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

Diabetes Dialogue: AHA 2024 and Semaglutide News

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.

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; 

Presented at AHA 2024, SUMMIT was a phase 3, placebo-controlled, double-blind, international trial assessing the safety and efficacy of tirzepatide among 731 adult patient adults with HFpEF and obesity, with or without type 2 diabetes, from 10 countries across 4 continents.

Results of the trial suggested a primary composite endpoint event occurred among 9.9% of the tirzepatide group and 15.3% of the placebo group (HR, 0.62; 95% CI, 0.41 to 0.95; 

 = .026). Analysis of KCCQ-CSS at 52 weeks suggested use of tirzepatide was associated with a mean change of 19.5 (SD, 1.2) from baseline to week 52 compared to a change of 12.7 (SD, 1.3) among the placebo group (between-group difference, 6.9; 95% CI, 3.3 to 10.6; 

An analysis leveraging NHANES data from 2015-2020 and eligibility criteria from pivotal trials for semaglutide’s approvals in type 2 diabetes, weight management, and secondary prevention of cardiovascular disease suggest more than half of all US adults would be considered eligible under these criteria.

From 25,531 survey participants, investigators identified 8504 individuals eligible for semaglutide, which is representative of 136.8 million (95%CI, 128.4 million to 145.2 million) US adults. Led by investigators at Harvard, Northwestern, and other leading institutions, concluded 35.0 million adults qualified for use based on its diabetes indication, 129.2 million were eligible based on its weight management indication, and 8.9 million were considered eligible based on its indication for secondary prevention of cardiovascular disease.

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.

Ning G, Wang W, He J, Bi Y, et al. Effects of Intensive Blood Pressure Control in Patients with Type 2 Diabetes. Presented at the American Heart Association (AHA) Scientific Sessions 2024. Chicago, Illinois. November 16-18, 2024.

Tirzepatide for Patients with Heart Failure with Preserved Ejection Fraction and Obesity: the SUMMIT Trial

. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed November 16, 2024.

Shi I, Khan SS, Yeh RW, Ho JE, Dahabreh IJ, Kazi DS. Semaglutide Eligibility Across All Current Indications for US Adults. 

 Published online November 18, 2024. doi:10.1001/jamacardio.2024.4657

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The discussion centers on recent advancements in diabetes management and incretin therapies, focusing on three key studies. The BPROAD trial, presented at the AHA 2024, demonstrated that intensive blood pressure control in older adults with type 2 diabetes significantly reduces cardiovascular events. The SUMMIT trial highlighted tirzepatide's efficacy in reducing heart failure events in patients with HFpEF and obesity. An NHANES analysis revealed that over 50% of US adults meet the eligibility criteria for semaglutide, underscoring its potential widespread impact on diabetes and weight management.

In this episode, hosts break down a pair of studies from AHA 2024, BPROAD and SUMMIT, as well as a study in JAMA projecting semaglutide eligibility in US adults.

Diabetes Dialogue: News and Updates in Diabetes at AHA 2024

Welcome back to this special World Diabetes Day edition 

Diabetes Dialogue: Tirzepatide’s Long-Term Obesity Data

00:00 Introduction and discussion of GLP-1 agonist shortages

0:03:34 Compounded medications and FDA regulations

0:07:30 Discussion of tirzepatide clinical efficacy

0:10:27 Long-term benefits and future prospects

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 

, 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 

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.

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The episode delves into recent developments in GLP-1 receptor agonists, focusing on tirzepatide's long-term data and GLP-1 shortages. The FDA reports stabilization in GLP-1 supply, potentially reducing reliance on unapproved versions. The SURMOUNT-1 trial shows tirzepatide's sustained weight loss and significant reduction in diabetes progression. The hosts emphasize tirzepatide's promising outcomes in obesity, sleep apnea, and heart failure, advocating for personalized medicine. They encourage clinicians to stay updated on GLP-1 research for chronic disease prevention and treatment, highlighting the importance of ongoing data analysis.

In this episode, hosts explore the most recent updates surrounding GLP-1 receptor agonists, including GLP-1 shortages and long-term data on tirzepatide.

Diabetes Dialogue: Latest Updates on Semaglutide Shortage, Data

01:25 - Discussion of the SOUL trial for oral semaglutide and cardiovascular events.

00:06:39 - Discussion of the higher dose 25 mg and 50mg oral semaglutide trials for obesity.

00:10:16 - Semaglutide and osteoarthritis.

00:18:47 - Semaglutide in patients with kidney disease without diabetes.

00:22:51 - Data from the SELECT trial on semaglutide's impact in patients with heart failure.

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 

 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 

. The episode concludes with a call to payers to support wider coverage, given the compelling data on reduced hospitalization and improved patient outcomes.

Novo Nordisk has resolved the semaglutide shortage, a significant development for diabetes management. Recent trials, including SOUL and SELECT, highlight semaglutide's cardiovascular and anti-inflammatory benefits, with oral formulations offering a 14% reduction in major adverse cardiovascular events and significant weight loss. These findings suggest expanded treatment options for patients preferring oral medications. Additionally, semaglutide shows promise in reducing osteoarthritis pain and kidney disease risk. The episode emphasizes the need for broader insurance coverage to enhance patient access to these therapeutic benefits.

In this episode, hosts discuss the latest developments in GLP-1 receptor agonists, with a particular focus on semaglutide.

Diabetes Dialogue: Latest Updates on Semaglutide

Diabetes Dialogue: October 2024 Tech Updates

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:

: 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.

: 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.

: 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.

Beta Bionics. Beta bionics announces launch of the Ilet Bionic Pancreas with Abbott’s Freestyle Libre 3 Plus Sensor. Beta Bionics. October 29, 2024. Accessed November 11, 2024. https://www.betabionics.com/beta-bionics-announces-launch-of-the-ilet-bionic-pancreas-with-abbotts-freestyle-libre-3-plus-sensor/.

Tidepool. Tidepool will integrate with Abbott’s Freestyle Libre portfolio for seamless cloud-to-cloud data. Business Wire. October 28, 2024. Accessed November 11, 2024. https://www.businesswire.com/news/home/20241024402862/en/Tidepool-Will-Integrate-With-Abbott%E2%80%99s-FreeStyle-Libre-Portfolio-for-Seamless-Cloud-to-Cloud-Data.

Insulet Corporation. Omnipod® 5 app for iPhone® now fully available in the United States. Business Wire. October 29, 2024. Accessed November 11, 2024. https://www.businesswire.com/news/home/20241029838744/en/Omnipod%C2%AE-5-App-for-iPhone%C2%AE-Now-Fully-Available-in-the-United-States.

Recent advancements in diabetes technology include the integration of Abbott's FreeStyle Libre 3 with Beta Bionics' iLet Bionic Pancreas, enhancing patient flexibility and convenience during imaging procedures. Tidepool's new data integration with Abbott streamlines data review by consolidating multiple CGM data into a single platform. Insulet Corporation's Omnipod 5 App is now available for iPhone users, offering features like preset meal settings for flexible carb counting. These updates reflect significant progress in continuous glucose monitoring and insulin delivery systems.

In this episode, hosts spotlight updates on Abbott’s Libre 3, Tidepool integration, and Omnipod 5 iOS app, expanding flexibility in diabetes management.

Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCE

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