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

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

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

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

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

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

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

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

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

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

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

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

In this episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP,  welcome Muthiah Vaduganathan, MD, MPH, cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, for a discussion around topline data updates from the SUMMIT and FINEARTS-HF trials, the latter of which Vaduganathan served on as a trial investigator.

Video Version: https://www.hcplive.com/view/diabetes-dialogue-summit-and-finearts-hf-with-muthiah-vaduganathan-md-mph

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).

Less than a week later, on August 05, 2024, Bayer announced results from the phase 3 trial of their nonsteroidal mineralocorticoid receptor antagonist, finerenone (Kerendia), among patients with heart failure with mildly reduced or preserved ejection fraction. According to Bayer, FINEARTS-HF met its primary endpoint, with achieving a statistically significant reduction of the composite of cardiovascular death and total heart failure events relative to placebo therapy.

The trial is due to be presented in a Hot Line session at the upcoming European Society of Cardiology Congress and Bayer plans to discuss the data and submission for regulatory approval with the US Food and Drug Administration. 

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

Video Version: https://www.hcplive.com/view/diabetes-dialogue-simplera-cgm-and-medtronic-partnership-with-abbott 

Even with the second half of the trial yet to be completed, results of the CATALYST trial have initiated a potentially seismic shift in discussions around the management of type 2 diabetes.

With the first part of the trial suggesting approximately 1-in-4 patients with difficult-to-control type 2 diabetes, results suggest hypercortisolism could be an underlying driver of suboptimal disease management for millions of people with type 2 diabetes in the US. Now, with this knowledge in hand, the community waits with bated breath for Corcept Therapeutics’ announcement of results from the second half of the trial, which assessed the use of mifepristone (Korlym) by randomizing patients who were diagnosed with hypercortisolism in a 2:1 ratio to mifepristone or placebo therapy.

Principal investigator John Buse, MD, PhD, chief of the Division of Endocrinology and the director of the University of North Carolina’s Diabetes Care Center, Buse and fellow investigators presented full data from the first half of the prevalence trial at the 84th American Diabetes Association Scientific Sessions

The first half of CATALYST was designed to assess the prevalence of hypercortisolism among 1000 patients from 36 study sites. For inclusion in the study, patients needed to have an HbA1c greater than 7.5% despite receiving optimal therapies. Of note, the trial defined optimal therapies for type 2 diabetes as 3 or more antihyperglycemic agents or 2 or taking insulin and other antihyperglycemic agents. Once identified, participants were required to complete a dexamethasone suppression test. If the values from this test were greater than 1.8 µg/dL and dexamethasone levels were greater than 140 ng/dL, these patients were considered as having hypercortisolism.

Results indicated the prevalence of hypercortisolism among patients with difficult-to-control type 2 diabetes was 24% (n=253 of 1055; 95% CI, 21.4 to 26.7). Buse highlighted 35.4% of those with hypercortisolism were taking 3 or more antihypertensive medications and were more likely to have cardiovascular risk relative to those without hypercortisolism.

In this episode, Buse joins hosts to discuss the trial background, expected prevalence, reaction to results, and the importance of the second part of the trial as the community moves into the future with knowledge of the true prevalence of hypercortisolism in difficult-to-control type 2 diabetes.

00:00 - Introduction and background on Dr. John Buse and his practice

01:08 - Overview of the CATALYST trial

02:09 - Surprising results from the screening phase

07:36 - Characteristics of patients who tested positive

12:36 - Implications for clinical practice and potential changes to screening guidelines

15:52 - Hypothesized benefits of mifepristone treatment and plans for presenting the results

Less than a month after rebranding from JDRF to Breakthrough T1D, the leading type 1 diabetes advocacy organization has now released new consensus guidance related to the monitoring of early-stage type 1 diabetes.

Debuted on the final day of the 84th American Diabetes Association Scientific Sessions, the consensus document seeks to fill a gap in guidance around autoantibody-positive individuals in early-stage type 1 diabetes as the community develops new means to delay or prevent progression of the disease. Proof of the document’s significance, it has received endorsement from both the ADA and the European Association for the Study of Diabetes, with simultaneous publication in Diabetes Care and Diabetologia.

“We are experiencing a paradigm shift in type 1 diabetes care, and we can now identify people in the earlier, presymptomatic stages of type 1 diabetes, before insulin is required, and intervene,” said Anastasia Albanese-O’Neill, PhD, APRN, associate vice president of Breakthrough T1D. “Until now, there was no consensus on how to care for these individuals in the clinical setting and provide appropriate education and psychological support. This new guidance should be used widely by healthcare providers to inform and guide the care of individuals in early stage T1D.”

Presented in a special symposium dedicated to the new consensus guidance, the document clocks in at 29 pages in length and cites more than 170 references. Included within the guidance are specific sections dedicated to monitoring among children and adolescents, adult patients, and pregnant patients. Beyond guidance on monitoring, the document also dedicates space to outlining updated terminology on type 1 diabetes staging and how to provide psychosocial and educational support for affected individuals and families.

To learn more about this new guidance and discuss the future of type 1 diabetes, hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, Diana Isaacs, PharmD, and Natalie Bellini, DNP, sat down with Albanese-O’Neill at ADA 2024. During their conversation, hosts discuss the recent name change to Breakthrough T1D, the growing prevalence of adults being diagnosed with type 1 diabetes, and major takeaways from the consensus guidance.

At the 84th American Diabetes Association (ADA) Scientific Sessions, INHALE-3 was among the trials to take center stage.

A phase 4 trial comparing the use of inhaled insulin (Afrezza) against standard care, results demonstrated use of inhaled insulin, in addition to insulin degludec, was associated with improved HbA1c in patients with type 1 diabetes, with an improvement of 0.5% or greater observed among 21% of those on inhaled insulin and 5% of those with usual care.

At the meeting, study investigator Grazia Aleppo, MD, professor of Medicine and director of the Diabetes Center at Northwestern University, joined hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, for a discussion on the trial, results, considerations for practicing clinicians, and next steps for research. In the latter portion of the episode, Aleppo, who serves on the guideline writing committee for the ADA Standards of Care discusses recent updates in diabetes technology.

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:

As part of their on-site presence at the 84th American Diabetes Association Scientific Sessions, Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, invited Monica Gomberg, MD, Vice President, Clinical Care at Blue Circle Health, to take part in this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives.

In this special edition episode from the 84th American Diabetes Association Scientific Sessions, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Davida Kruger, NP, a certified nurse practitioner in the Division of Endocrinology at Henry Ford Health System in Detroit.

During the episode, Kruger takes hosts on a deep dive into the latest in diabetes technology at the meeting, with a focus on advancement in automated insulin delivery and continuous glucose monitoring (CGM) technology. In the early half of the episode, Kruger discusses the results of the SECURE-T2D trial, which examined use of the Omnipod 5 in patients with type 2 diabetes using insulin, and, later in the episode, Kruger offers her perspective on the age of over-the-counter CGM in the wake of announcements from Dexcom and Abbott earlier this year.

Video Version: https://www.hcplive.com/view/diabetes-dialogue-advances-in-aid-and-cgm-at-ada-2024-with-davida-kruger-np 

On the opening day of the 84th American Diabetes Association Scientific Sessions, the ADA ushered in a new era for their organization with the announcement of the formation of the Obesity Association.

Created more than a decade after the American Medical Association recognized obesity as a disease, the new subdivision of the ADA was created to further the organization’s mission of advocating for and advancing treatment for patients. According to a news release, the ADA intends to develop a Standards of Care for Obesity and to leverage education, advocacy and evidence-based support to reduce barriers to optimal care for people affected by diabetes for people with and without diabetes.

As part of the on-site coverage of ADA 2024, Diana Isaacs, PharmD, and Natalie Bellini, DNP, hosts sat down with Robert Gabbay, MD, PhD, the chief scientific and medical officer of the ADA, for more insight into the newly formed Obesity Association, future plans, and how this move reflects the changing landscape of metabolic health.