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.

0:00 Introduction and Background of DreaMed Diabetes

1:46 Current Functionality and Features of DreaMed Diabetes Platform

4:44 Algorithm Capabilities and Insights

7:06 Cloud-to-Cloud Integration and User Engagement

9:37 Onboarding Process and Data Analysis

21:00 Financial Benefits and Budget Neutrality

25:31 Future Enhancements and Broader Applications

Video Version only on HCPLive! 

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center explore the increasing focus on the connection between obesity and diabetes, including the latest advancements in glucagon-like peptide-1 (GLP-1) receptor agonist therapies, the use of inhaled insulin, and the recent addition of hypercortisolism to the “Ominous Octet”, creating the “Noxious Nine.”

Although obesity rates in the US have been rising steadily globally, hosts pointed to a recent CDC report reporting a slight decrease in obesity rates. They suggest that this may be partially attributed to the impact of GLP-1 drugs, which have become increasingly popular in managing obesity and related metabolic disorders, including type 2 diabetes (T2D). With these drugs continuing to show promising results, the hosts express optimism about their potential to reduce obesity and improve long-term patient health outcomes.

Their conversation shifted to a detailed discussion of the INHALE-1 trial, which evaluated the effectiveness of inhaled insulin in children with type 1 diabetes (T1D) and T2D. The trial, designed to evaluate the non-inferiority of inhaled insulin compared to traditional subcutaneous injections, found that inhaled insulin provided similar efficacy without significant differences in lung function or hypoglycemia occurrence. Isaacs and Bellini highlighted the implications of these findings, emphasizing that inhaled insulin could offer an alternative treatment option for pediatric patients, particularly those who struggle with needle phobia or the burden of multiple daily injections (MDIs).

The episode concluded with a deep dive into the Catalyst study, which explored the use of mifepristone in patients with T2D complicated by hypercortisolism. The second phase of the Catalyst trial found a significant reduction in HbA1C levels, showing a 1.5% decrease in patients treated with mifepristone compared with the placebo group. Isaacs and Bellini discussed the potential clinical applications of these results, particularly for patients with difficult-to-control diabetes who may have an underlying hormonal issue contributing to their condition. Overall, hosts encouraged clinicians to consider hypercortisolism in their differential diagnosis for patients with challenging diabetes cases, noting the promise that mifepristone could offer as an adjunctive treatment.

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.

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.

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.

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.

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.

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

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.

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.

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 <.001).

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; P = .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; P <.001).

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.

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.

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.

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.

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.

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.