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

Diabetes Dialogue: ADA 2025 Preview

With a number of late-breaking presentations and high-profile phase 2 and 3 trials, the 2025 American Diabetes Association (ADA) Scientific Sessions reflect how rapidly the treatment landscape for obesity and diabetes is evolving. This year’s meeting, held June 20–24 in Chicago, will showcase significant updates on combination therapies, once-weekly insulin regimens, and novel mechanisms that may redefine standards of care for both type 1 and type 2 diabetes.

Among the highlights: new efficacy and safety data for GLP-1–based therapies, novel amylin analog combinations, and once-monthly treatment options signal a shift toward personalization and convenience in metabolic care.

In this special episode of Diabetes Dialogue cohosts 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, preview the most anticipated data, explore clinical implications, and discuss what may come next in the exciting pipelines for diabetes and obesity.

During the meeting, Isaacs will also participate in a debate on over-the-counter continuous glucose Monitoring with David Ahn, MD, of Hoag, on Friday, June 20, and Bellini will chair 2 sessions, “Real-World Automated Insulin Delivery System Results” on June 20, and “Advances and Trends in Diabetes Technology” on June 22.

Diabetes Dialogue: Trials to Watch at ADA 2025

Once-Monthly MariTide for the Treatment of Obesity in People With or Without Type 2 Diabetes—A 52-Week Phase 2 Study

Monday, June 23, 2025, from 1:30-3:00 pm CDT


Ania M. Jastreboff, MD, PhD, of Yale University


In the last few years, the emergence of highly effective incretin-based therapies such as glucagon-like peptide 1 (GLP-1) receptor agonists (RA) has transformed obesity care. A new contender in the GLP-1 RA field is maridebart cafraglutide, or MariTide, which is being evaluated in a phase 2 study.

The study enrolled 592 adults into 2 cohorts with or without type 2 diabetes (T2D) and Amgen previously shared pooled data from the study demonstrating an average weight loss of around 17% without a plateau. During the ADA SciSessions, Jastreboff will present the unpooled data for each of the treatment arms in people with obesity and details of cardiometabolic measures for people with and without T2D for the first time.

Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes—Final Results of the CATALYST Trial

Monday, June 23, 2025, from 3:15-4:15 pm CDT


Vivian Fonseca, MD, of Tulane University


During last year’s SciSessions, Fonseca and colleagues presented data highlighting the prevalence of hypercortisolism in people with difficult-to-manage T2D – which was a surprising 24% of the 1055 participants enrolled in the first phase of the CATALYST trial.

At this year’s meeting, the investigators return to present the efficacy and safety of the glucocorticoid receptor modulator mifepristone in participants with hypercortisolism and difficult-to-manage T2D in the second phase of the Corcept Pharmaceuticals-sponsored trial. The new data, investigators say, support a paradigm shift in diabetes care to screen for and treat hypercortisolism as an approach to improve glycemic control.

Can We Improve the Quality of Weight Loss by Augmenting Fat Mass Loss While Preserving Lean Mass? The BELIEVE Study of Bimagrumab + Semaglutide

 Monday, June 23, 2025, from 8:00-9:30 am CDT


: Steven B. Heymsfield, MD, of Pennington Biomedical Research Center


Although GLP-1 RAs such as semaglutide become more prevalent in treatment strategies for weight loss, questions remain as to the potential merit of combination therapy vs monotherapy. The phase 2 BELIEVE trial of bimagrumab plus semaglutide versus bimagrumab monotherapy sought to answer this question and theorized that the addition of bimagrumab will preserve lean mass in study participants.

Heymsfield will present efficacy and safety data from the trial, which enrolled 500 participants at 26 centers across the United States with baseline BMI of≥30 or≥27 with obesity-associated comorbidities and obesity refractory to at least 1 behavioral attempt to lose body weight. The primary outcome is change in body weight and secondary outcomes include change in waist circumference, change in BMI, change in percent body fat, change in visceral and subcutaneous adipose tissue, change in trunk fat mass, percentage of weight loss due to fat mass or lean mass, quality of life, and more.

Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial

Saturday, June 21, 2025, from 1:30-3:00 pm CDT


Subodh Verma, MD, PhD, FRCSC, of St. Michael's Hospital


In recent years, semaglutide has taken on a lead role in revolutionizing the role of GLP-1 receptor agonists in care for weight loss, diabetes, cardiovascular risk reduction in adults with T2D and known heart disease, and worsening kidney disease and cardiovascular death risk reduction in people with chronic kidney disease and T2D.

Another indication that seems poised to add to the mix is peripheral artery disease (PAD) with T2D. Funded by Novo Nordisk, STRIDE was launched in 2020 as a double-blind, randomized, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe. The trial enrolled adults with PAH and T2D evaluating a primary outcome of the ratio from baseline of the maximum walking distance at week 52, measured on a constant load treadmill. The trial has randomized 792 participants 1:1 to placebo or semaglutide. Key efficacy, epidemiology, and biomarker data from the trial will be presented.

Efficacy and Safety of CagriSema 2.4mg/2.4mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials

Sunday, June 22, 2025, from 8:00–9:30 am CDT


W. Timothy Garvey, MD, of University of Alabama at Birmingham; Melanie J. Davies, MB, ChB, MD, University of Leicester; and Sue D. Pedersen, MD, of University of Calgary


Another clinical trial program seeking to investigate potential combination therapies with semaglutide is the REDEFINE program, which is evaluating semaglutide and long-acting amylin analogue cagrilintide combination therapy (termed CagriSema) in people who are overweight/obese with or without T2D. The program, sponsored by NovoNordisk, consists of REDEFINE 1 in individuals without T2D, and REDEFINE 2 in individuals with T2D. Both populations have demonstrated notable weight loss after 68 weeks.

During the meeting, Garvey will break down the topline efficacy results of REDEFINE 1 and Davies will detail efficacy findings in REDEFINE 2 including continuous glucose monitoring (CGM), time in range (TIR), A1C, and other secondary endpoints. Furthermore, Pedersen will detail safety findings.

Advancing and Facilitating Basal Insulin Therapy in Type 2 Diabetes—Breaking News on the QWINT 1, 3, and 4 Trials with Once-Weekly Insulin Efsitora Alfa!

 Sunday, June 22, 2025, from 1:30–3:00 pm CDT


Chantal Mathieu, MD, PhD, of Katholieke Universiteit Leuven; Athena Philis-Tsimikas, MD, of Scripps Research Translational Institute; and Julio Rosenstock, MD, of University of Texas


The QWINT program, sponsored by Eli Lilly, is investigating weekly dosing of basal insulin compared to daily dosing, which could ease treatment burden in patients with T2D. The program consists of QWINT-2, which previously demonstrated safety and efficacy of insulin efsitora alfa; QWINT-1, which is evaluating a new approach to basal insulin dose escalation in patients with insulin-naïve T2D; QWINT-3, which is comparing insulin efsitoria as a weekly basal insulin with insulin degludec in participants with T2D currently treated with basal insulin; and QWINT-4, which is tracking patients with insulin-experienced T2D taking both bolus and mealtime insulin. The latest findings will be presented at Scientific Sessions from QWINT-1, 3, and 4.

ADJUnct Semaglutide Treatment in Type 1 Diabetes (ADJUST-T1D) Trial Outcomes

Current approved use of semaglutide is limited to patients with T2D and is currently only off-label for people with T1D. The ADJUST-T1D trial seeks to formally evaluate the therapy’s efficacy in people with T1D and obesity, using FDA-approved hybrid closed-loop therapies.

The trial’s primary outcome is the proportion of adults with T1D achieving a composite outcome of CGM-measured TIR 70% with time below range of <4% and reduction in body weight by 5% at 26 weeks in the semaglutide group compared to placebo group. Secondary outcomes include other biomarkers and CGM measures. Kruger will present topline data during the meeting.

Videos

In this special episode, cohosts preview the most anticipated data and explore clinical implications in diabetes and obesity.

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

Diabetes Dialogue: American Diabetes Association Consensus Report on MASLD

cohostsDiana 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, examine a newly released American Diabetes Association (ADA) consensus report titled 

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People with Diabetes: The Need for Screening and Early Intervention

. The publication emphasizes the importance of recognizing 

 as a critical comorbidity in individuals with type 2 diabetes and prediabetes and outlines guidance for clinicians to improve early detection, risk stratification, and treatment strategies.

The episode begins by placing MASLD in historical context alongside other comorbidities such as cardiovascular disease, chronic kidney disease, and hypertension. The hosts explain that MASLD, previously referred to as nonalcoholic fatty liver disease or NAFLD, reflects a metabolic-driven pathology and is now better understood as a progressive condition that increases the risk of cirrhosis, liver transplantation, cardiovascular disease, and impaired quality of life. The more advanced form, MASH (Metabolic dysfunction-associated steatohepatitis), represents progression toward hepatic fibrosis and cirrhosis.

A major focus is the Fibrosis-4 (FIB-4) score, a noninvasive, cost-effective screening tool calculated from common laboratory tests (platelets and liver function markers) to assess fibrosis risk. The consensus report advises routine FIB-4 scoring in adults with type 2 diabetes, particularly those with central obesity. Based on risk thresholds, further evaluation may involve transient elastography (FibroScan), advanced imaging, or hepatology referral.

The hosts commend the ADA for offering a clear clinical algorithm for evaluation and referral, as well as pharmacotherapy recommendations tailored to disease severity. For individuals with early-stage fibrosis, lifestyle modification and diabetes therapies such as GLP-1 receptor agonists (eg, semaglutide) are first-line approaches. For advanced fibrosis (F2–F3), resmetirom is the only currently approved treatment for MASH. The report also highlights complications from hepatic dysfunction—including impaired hypoglycemia awareness and sarcopenia—underscoring the broader metabolic impact of MASLD.

Isaacs and Bellini stress that MASLD should be approached with the same clinical rigor as other diabetes-related complications. They recommend integrating automated FIB-4 scoring in EHRs, interdisciplinary collaboration with hepatology, and clinician education using decision tools from the consensus report.

Cusi K, Abdelmalek MF, Apovian CM, et al. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People With Diabetes: The Need for Screening and Early Intervention. A Consensus Report of the American Diabetes Association. 

Podcasts

Hosts discuss a consensus repot from the ADA focused on screening and early interview of MASLD in people with diabetes.

Diabetes Dialouge: May 2025 Diabetes Tech & Breakthrough T1D Updates

, co-hosts 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, discuss significant developments in diabetes care from May 2025, including Medtronic’s restructured business model, Sequel Twiist’s technological collaboration with Abbott, and Breakthrough T1D’s efforts to advance early detection of 

The discussion opens with news of Medtronic’s decision to spin off its diabetes division into a standalone entity, currently referred to as “New Diabetes Company.” While the final name is forthcoming, the move is intended to streamline operations and accelerate innovation within the diabetes space. The hosts highlight the company’s promising technology pipeline, including the forthcoming 800 series insulin pump with full smartphone control and plans for a tubeless insulin delivery system. Both experts express optimism that the independence may foster greater agility in product development, enhance accessibility, and maintain a focus on user-centered design, including for populations with visual impairments.

Next, Isaacs and Bellini examine the announcement of the Sequel Twiist partnership with Abbott to integrate continuous ketone monitoring (CKM) into a hybrid sensor, which is expected to function similarly to the FreeStyle Libre 3. This device, still in development, will provide real-time data on both glucose and ketone levels—a critical advance for people with type 1 diabetes using insulin pumps, who are at elevated risk for diabetic ketoacidosis (DKA). While excited about the potential for earlier DKA detection, Bellini emphasizes the importance of cost-effective implementation and integration with existing pump platforms.

The episode concludes with coverage of Breakthrough T1D’s advocacy before the US Preventive Services Task Force to support routine screening for T1D autoantibodies. The goal is to identify individuals in early stages of the disease to prevent DKA and misdiagnosis. The hosts note that despite advancements in understanding T1D progression, many patients remain undiagnosed until presenting with DKA or are mistakenly classified as having 

Medtronic plc. Medtronic announces intent to separate Diabetes business. Medtronic News. Published May 21, 2025. Accessed June 2, 2025. 

https://news.medtronic.com/2025-05-21-Medtronic-announces-intent-to-separate-Diabetes-business

Sequel Med Tech. Sequel Med Tech to Integrate twiist Automated Insulin Delivery (AID) System with Abbott’s Future Dual Glucose-Ketone Sensor. GlobeNewswire News Room. Published May 22, 2025. Accessed June 2, 2025. 

https://www.globenewswire.com/news-release/2025/05/22/3086535/0/en/Sequel-Med-Tech-to-Integrate-twiist-Automated-Insulin-Delivery-AID-System-with-Abbott-s-Future-Dual-Glucose-Ketone-Sensor.html

Breakthrough T1D. Breakthrough T1D Submits Application to Make Screening for Type 1 Diabetes Part of Recommended Preventive Services in the US - Breakthrough T1D. Breakthrough T1D. Published May 21, 2025. Accessed June 2, 2025. 

https://www.breakthrought1d.org/for-the-media/press-releases/breakthrough-t1d-submits-application-to-make-screening-for-type-1-diabetes-part-of-recommended-preventive-services-in-the-us/

Hosts breakdown diabetes technology updates from May 2025 and Breakthrough T1D's push for improved screening.

Diabetes Dialogue: INHALE-3 Trial and Afrezza, With Roy Beck, MD, PhD

Introduction and Background of Dr. Roy Beck

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, are joined by Roy Beck, MD, PhD, executive director of the Jaeb Center for Health Research, to discuss the INHALE-3 trial, an adult study evaluating technosphere inhaled insulin (Afrezza) in comparison to standard 

, including automated insulin delivery (AID) systems.

Beck outlined his center’s transition from ophthalmology-focused research to becoming a key player in diabetes trials over the last 25 years, particularly in technology-driven therapies. The conversation explores inhaled insulin’s pharmacokinetic profile—its rapid onset and short duration, which more closely mimics physiologic insulin responses than injected rapid-acting analogs.

The INHALE-3 trial randomized adults with type 1 diabetes (T1D), including nearly 50% who were on AID systems, to either continue their current regimen or switch to once-daily insulin degludec plus Afrezza for meals and corrections. Surprisingly, Beck highlighted participants willing to suspend AID use to try the inhaled approach, allowing for a head-to-head comparison. The study met its primary non-inferiority endpoint for HbA1c, with outcomes from Afrezza plus basal insulin comparable to those achieved with AID and multiple daily injections.

However, Beck emphasized the heterogeneity in response. Approximately 30% of participants switching to Afrezza achieved notably better glycemic control (including greater reductions in HbA1c and less time >250 mg/dL), while a similar proportion performed worse, largely depending on their engagement and dosing frequency. CGM use was required in the study, enabling patients to re-dose Afrezza postprandially as needed, a key factor in those who succeeded.

Beck also indicated that overnight glycemic control remained a challenge. While Afrezza performed well during daytime periods, AID systems outperformed it overnight—an expected finding given AID’s strength in basal modulation. Weight gain was also lower in the Afrezza group, offering an additional potential advantage.

Hosts discussed real-world use cases combining AID with Afrezza, with Beck sharing his son’s personal success using Afrezza alongside Tandem Diabetes’ Control-IQ in sleep mode, a workaround to prevent algorithmic overlap. He noted future integration could be more seamless with upcoming Bluetooth-enabled Afrezza inhalers or AID systems capable of receiving inhalation data.

Safety data showed bronchospasm was rare in the trial, with no confirmed cases attributable to Afrezza. Cough was the most common side effect, generally mild and transient, while active asthma and smoking remained contraindications. Isaacs and Bellini highlighted Afrezza’s potential as an underutilized but powerful option in the diabetes toolkit, particularly for patients seeking alternatives to injections or pumps, or looking for greater control over postprandial excursions.

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.

In this episode, hosts explore technosphere inhaled insulin (Afrezza) in comparison to standard diabetes therapies in the INHALE-3 trial. 

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

Articles