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

In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, 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.

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.

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.

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.

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.

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.

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.

On August 15, 2024, the Biden-Harris Administration announced the price list for the first 10 drugs selected as part of the Medicare price negotiations between the United States Department of Health and Human Services (HHS) and pharmaceutical manufacturers.

“Americans pay too much for their prescription drugs. That makes today’s announcement historic. For the first time ever, Medicare negotiated directly with drug companies and the American people are better off for it,” said HHS Secretary Xavier Becerra.

Part of the Inflation Reduction Act, the announcement of intended pricing for these agents comes nearly a year after the Centers for Medicare and Medicaid Services (CMS) announced the list of the first 10 agents included in the negotiations. The list, which consists of the 10 drugs with the highest gross annual spending total, accounts for $50.5 billion in total Part D gross covered prescription costs per year and more than $3.4 billion in out-of-pocket costs

Among the first 10 agents chosen, 4 have specific indications for patient populations with diabetes: empagliflozin, sitagliptin, dapagliflozin, and Novo Nordisk-specific insulin aspart products. According to CMS statistics, these 4 agents accounted for more than $16 billion in total Part D spending from June 1, 2022 through May 31, 2023.

These prices will come into effect starting January 1, 2026. As part of the Inflation Reduction Act, CMS will select up to 15 more drugs covered under Part D for negotiation in 2027, up to 15 more drugs in 2028, including drugs covered under Part B and Part D, and up to 20 more drugs for each year after.

A follow-up to their reaction episode earlier this year, this episode examines the price changes and what this could translate to for those with diabetes or members of the care team. In the episode, hosts discuss how significant reductions in the prices of SGLT2 inhibitors and insulin products will benefit people with diabetes, but point out the absence of long-acting insulin and GLP-1 agonists from the initial list is notable and will require continued negotiations.

Video Version: https://www.hcplive.com/view/diabetes-dialogue-first-10-prices-announced-from-cms-price-negotiations

The Association of Diabetes Care and Education Specialists (ADCES) is an organization ahead of its time in the world of healthcare. Often, those in medicine find the field to be reactionary instead of proactive in addressing the rising burden of chronic disease. The ADCES, formerly the American Association of Diabetes Educators, was founded in 1973 to support and educate clinicians, care providers, and patients of the latest advancements to improve care and quality of life for people with diabetes.

This mission, while important in the 1970s, has become crucial if health systems hope to combat a burgeoning diabetes crisis. In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, we celebrate the ADCES 2024 annual meeting through the perspective of hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center. The first of 2 scheduled episodes related to the meeting, this episode focuses on presentations and sessions Isaacs and Bellini were directly involved in from the meeting.

Key topics include the challenges of using insulin pumps for type 2 diabetes, the role of DME companies in accessing CGM for people with Medicare, and the latest research on automated insulin delivery systems during pregnancy. The hosts also discuss interpreting ambulatory glucose profiles and time-in-range targets. Throughout the conversation, Isaacs and Bellini share their enthusiasm for the advancements in diabetes technology and the importance of effective patient education and counseling.

Video Version: https://www.hcplive.com/view/diabetes-dialogue-navigating-adces-2024