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

Welcome back to 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.

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.

References

1. 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

2. 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

3. Livingston R. FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes. HCPLive. May 29, 2026. Accessed June 18, 2026. https://www.hcplive.com/view/fda-approves-inhaled-insulin-afrezza-pediatric-patients-diabetes