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

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Automated insulin delivery (AID) is moving toward systems demanding less from users, and new feasibility data suggest a next-generation algorithm may hold glycemic targets in 

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed first-in-human results for the MiniMed Vivera algorithm and the new type 2 diabetes clearance for the twiist AID system.

On this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss where automated insulin delivery is heading and what recent developments could mean for clinicians managing patients on pump therapy. The conversation covers new algorithm research and a recent regulatory update affecting people with type 2 diabetes. 

Diabetes Dialogue: MiniMed Vivera Data and Twiist Type 2 Clearance

The feasibility trial enrolled 24 adults with type 1 diabetes across 3 consecutive 3-week phases: full meal announcement, no meal announcement, and announcement at will.

 Mean time in range (70 to 180 mg/dL) was 82.3%, 73.8%, and 76.7% across the respective phases, with no device-related serious adverse events.

 Time below 54 mg/dL stayed between 0.2% and 0.3% in every phase.

The algorithm also permits a glucose target as low as 90 mg/dL and starts automated mode from total daily dose alone, without the manual-mode run-in required by the MiniMed 780G system. Most participants nonetheless kept a 100 mg/dL target, and a few selected a higher one.

Participants entered with tightly managed disease, with a mean baseline HbA1c of 6.9% and a run-in time-in-range of about 83% on the 780G system. Full-announcement results therefore matched the existing algorithm, placing the advance in performance without announcements. Outcomes in people with higher HbA1c, and the patient-reported burden of each announcement strategy, remain untested.

The FDA cleared the twiist system from Sequel Med Tech for adults with insulin-treated type 2 diabetes in October 2026. In the 13-week pivotal trial of 307 adults, HbA1c fell 0.7% (95% CI, -0.9 to -0.6), and time in range rose from 57% to 73% with no severe hypoglycemia.

 Labeling may ease payer coverage and support prescribing among clinicians less experienced with pump therapy.

The twiist algorithm draws on programmed basal rates and insulin sensitivity factors, a design closer to Control-IQ+ than to MiniMed or Beta Bionics systems. Clinicians familiar with the system report raising the maximum basal limit allows rapid correction of hyperglycemia, even among users who rarely bolus.

Collectively, the developments point toward AID systems requiring less user input across diabetes types. Pivotal trials in broader populations will determine whether reduced burden comes without meaningful glycemic tradeoffs.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Tirosh A, Wheeler BJ, Laron Hirsh M, et al. Efficacy and safety of the MiniMed Vivera algorithm: results from a first-in-human feasibility trial. 

Levy CJ, Kanapka L, Graham TE, et al. A multicenter 13-week evaluation of the twiist automated insulin delivery in insulin-treated type 2 diabetes: the twiist-T2D pivotal trial. 

Articles

Diana Isaacs, PharmD, and Natalie Bellini, DNP, review early MiniMed Vivera data on optional meal announcements and twiist's new type 2 diabetes clearance.

The diabetes community welcomed its second approved once-weekly insulin on September 24, 2026, as the 

 approval of insulin efsitora alfa-gobe (Onswik) for adults with 

 less than 7 months after the approval of insulin icodec (Awiqli).

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, FNP-BC, examined the approval, the phase 3 QWINT data behind it, and the practical demands of weekly dosing.

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

On this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, FNP-BC, talk through the latest addition to the weekly basal insulin landscape and what it means for clinicians starting or switching patients. Their conversation centers on real-world considerations for bringing a new insulin option into practice.

Diabetes Dialogue: FDA Approves Onswik, A Weekly Basal Insulin

Across the QWINT program, efsitora met its noninferiority end point for HbA1c reduction against once-daily glargine U-100 or degludec U-100, with reductions of 0.81 to 1.26 percentage points.¹⁻³ In insulin-naive adults in QWINT-1, a fixed-dose regimen lowered the rate of clinically significant or severe hypoglycemia by 43% vs glargine (rate ratio, 0.57; 95% CI, 0.39-0.84).¹ The hosts linked this advantage to a flatter pharmacokinetic profile, free of the end-of-interval waning seen with daily basal analogues.

Dosing departs from familiar basal insulin practice. The label offers a fixed-dose escalation from 100 units weekly through 150, 250, and 400 units at 4-week intervals, or a flexible titration opening with a 3-fold loading dose. For patients switching from daily basal insulin, clinicians multiply the daily dose by 7, then by 3 for the first week only.

With a half-life of about 17 days, efsitora reaches steady state slowly, and omitting the loading dose can leave patients with rising CGM readings for weeks. The hosts urged close adherence to the prescribing information, which reflects titration schemes validated across the QWINT trials. U-500 and U-1000 pens deliver up to 400 units and 800 units per injection, respectively, extending weekly dosing to patients with substantial insulin resistance.

Efsitora relies on an Fc-fusion design to slow renal clearance, distinguishing it from albumin-binding icodec. The label excludes type 1 diabetes, given higher hypoglycemia rates in trials, and flags potential risk in pregnancy and lactation based on animal data. No renal dose adjustment is required, although the hosts advised slower intensification in patients with renal impairment.

Collectively, efsitora gives clinicians a second weekly basal option capable of reducing basal injections from as many as 14 per week to 1. Its uptake will likely hinge on manufacturer-supported education around loading doses, concentrated pen conversions, and coverage, areas where the hosts saw gaps after the icodec launch.

Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. 

Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. 

Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. 

Podcasts

Discover how newly cleared weekly basal insulin efsitora reshapes type 2 diabetes care—QWINT results, hypoglycemia edge, and dosing tips.

Diabetes Dialogue: Weekly Insulin Efsitora Alfa Gets FDA Approval for Type 2 Diabetes

Diabetes Dialogue: Teplizumab, Stelo, and Inhaled Insulin Afrezza for Pediatric Patients

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

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss a series of major pediatric diabetes advancements announced around the American Diabetes Association (ADA) Scientific Sessions 2026, highlighting how recent regulatory decisions are expanding treatment options and improving access to diabetes technologies.

The conversation opens with the expanded FDA indication for teplizumab in children and adolescents with newly diagnosed stage 3 type 1 diabetes. Bellini reviews findings from the PROTECT trial, which evaluated teplizumab in patients ages 8 to 17 years within six weeks of diagnosis. She explains that treatment with two 12-day infusion courses resulted in significant preservation of endogenous insulin production, with 95% of participants maintaining peak C-peptide levels above the study threshold at week 78. The hosts discuss the importance of preserving residual beta-cell function, emphasizing its potential role in improving glycemic stability, reducing hypoglycemia risk, and supporting better long-term outcomes for individuals who will live with type 1 diabetes for decades.

Isaacs and Bellini explore how this new indication may change the approach to type 1 diabetes screening, particularly among first-degree relatives and individuals at higher risk for autoimmune disease. They note that identifying people in stage 2 type 1 diabetes remains challenging because patients are typically asymptomatic, but the availability of treatment at stage 3 provides clinicians with a new opportunity to intervene soon after diagnosis.

The hosts discuss how having an approved therapy may encourage more families to pursue screening and identify additional individuals with early-stage disease. They also address practical considerations, including the importance of starting treatment within the appropriate window, coordinating the two infusion courses, supporting families through treatment logistics, and ensuring access through insurance coverage.

The discussion then shifts to the FDA clearance of Dexcom Stelo, the first over-the-counter glucose biosensor cleared for pediatric use in children ages 2 years and older who do not use insulin. Isaacs highlights how this technology could improve access to glucose monitoring for children with prediabetes, type 2 diabetes, or those seeking greater insight into how food, activity, and lifestyle factors influence glucose patterns.

The hosts emphasize that expanded access to glucose monitoring could play an important role in helping families make informed decisions about diabetes management. However, they clarify that individuals using insulin require prescription continuous glucose monitoring systems with additional safety features, including hypoglycemia alerts and predictive low glucose notifications.

Finally, Isaacs and Bellini discuss the pediatric approval of inhaled insulin as another significant milestone in diabetes care. They review its potential as an alternative to mealtime injections and highlight the opportunity to provide more flexibility for children and families managing type 1 diabetes. The conversation also addresses implementation considerations, including baseline lung function testing, provider familiarity, and adapting clinical workflows to incorporate new treatment approaches.

The episode concludes by reflecting on the rapid progress occurring in pediatric diabetes care. With advances in immune-modulating therapies, glucose monitoring technology, and insulin delivery options, the hosts highlight a new era of personalized diabetes management focused on preserving insulin function, improving access, and optimizing outcomes for young people living with diabetes.

Sanofi. Press Release: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes. June 12, 2026. Accessed June 18, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-12-22-09-58-3311349

US Food and Drug Administration. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children. June 12, 2026. Accessed June 18, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children

Livingston R. FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes. 

https://www.hcplive.com/view/fda-approves-inhaled-insulin-afrezza-pediatric-patients-diabetes

This episode covers recent approvals and updated indications allowing more treatment options for children with diabetes.

Diabetes Dialogue: CONNECT, TRANSCEND, and TRIUMPH at ADA 2026

In this episode, shot live at the American Diabetes Association (ADA) Scientific Sessions 2026 in New Orleans, Louisiana, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the latest major trial results like CONNECT, TRIUMPH, and TRANSCEND.

To begin the episode, Isaacs and Bellini, discuss major highlights from ADA Scientific Sessions, focusing first on the landmark CONNECT trial evaluating continuous glucose monitoring (CGM) in people with type 2 diabetes who are not treated with insulin. They reflect on the evolution of CGM technology, from its early use primarily in type 1 diabetes to its expanding role in type 2 diabetes management, and explain why this trial represents an important step forward for patients who have historically had limited access to CGM.

The hosts review the randomized controlled trial findings, emphasizing the significant improvements in glycemic outcomes, including a 1.6% reduction in A1c from baseline and an approximately 0.9% greater reduction compared with standard care. They also highlight the increase in time in range, with participants using CGM achieving roughly five additional hours per day in target glucose range. The magnitude of these findings is discussed as a practice-changing development, with the potential to influence future clinical guidelines and strengthen recommendations for CGM use among individuals with type 2 diabetes who are not using insulin.

The discussion also explores the broader implications of the CONNECT trial for healthcare access and insurance coverage. The hosts note that randomized controlled trial evidence has historically played a key role in shaping standards of care and payer decisions, and they suggest that these results may help support wider adoption of CGM by demonstrating meaningful improvements in glucose control and patient outcomes.

The conversation then shifts to emerging pharmacologic advances, with a focus on retatrutide, a novel triple agonist targeting GLP-1, GIP, and glucagon pathways. The hosts discuss new data showing substantial metabolic benefits in people with type 2 diabetes, including up to 17% weight reduction and nearly 2% A1c lowering. They highlight how these findings represent a major advancement in diabetes and obesity treatment, particularly as clinicians continue to see increasingly powerful effects from next-generation incretin-based therapies.

Isaacs and Bellini explore how these therapies may reshape treatment strategies by allowing clinicians to tailor medication choices based on individual patient needs and goals. They discuss the importance of considering both glucose lowering and weight reduction effects, recognizing that some patients may benefit from significant weight loss while others may require a more balanced approach focused primarily on glycemic improvement.

The hosts also address important unanswered questions surrounding the use of highly effective weight-loss medications, including appropriate treatment targets, the limitations of BMI as a measure, and the importance of preserving muscle mass and overall function. They emphasize the need to consider body composition, physical activity, resistance training, and patient characteristics—particularly in older adults or those at risk for frailty—when developing long-term treatment plans.

The episode concludes with a reflection on the rapidly evolving landscape of diabetes care. The hosts highlight how advances in CGM technology and novel metabolic therapies are creating new opportunities to improve outcomes, personalize treatment approaches, and redefine the future management of people living with diabetes.

Dexcom. Dexcom CONNECT Study: The Most Significant Clinical Study Demonstrating CGM Benefits for People with Type 2 Diabetes Not Using Insulin. June 6, 2026. Accessed June 11, 2026. 

https://investors.dexcom.com/news/news-details/2026/Dexcom-CONNECT-Study-The-Most-Significant-Clinical-Study-Demonstrating-CGM-Benefits-for-People-with-Type-2-Diabetes-Not-Using-Insulin/default.aspx

Bajaj HS, Welch M, Shah P, et al. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. Published online June 6, 2026. 

Livingston R. TRIUMPH-1: Retatrutide Substantially Lowers Weight, BMI in Patients With Obesity or Overweight. 

https://www.hcplive.com/view/triumph-1-retatrutide-substantially-lowers-weight-bmi-in-patients-with-obesity-or-overweight

This episode covers recently released data regarding the Dexcom G7 and Eli Lilly’s investigational triple agonist retatrutide from ADA 2026.