Insulet Corporation (NASDAQ: PODD), a leader in tubeless insulin pump technology under the Omnipod® brand, has unveiled positive outcomes from its pivotal trial of the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for type 2 diabetes at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida.
The SECURE-T2D trial demonstrated significant glycemic improvements with Omnipod 5 compared to previous insulin injections or pump therapies in adults with type 2 diabetes. Results showed substantial reductions in HbA1c levels, time spent in hyperglycemia, and total daily insulin doses, alongside notable enhancements in time in range (TIR) without increasing hypoglycemia risk. The study also highlighted a clinically meaningful reduction in diabetes distress.
“Simple and user-friendly AID technology like Omnipod 5 can effectively benefit a wide range of individuals living with type 2 diabetes and enhance their quality of life,” remarked Dr. Trang Ly MBBS, FRACP, PhD, Senior Vice President and Medical Director at Insulet. “The diversity of participants in this study, including varied educational backgrounds, income levels, ethnicities, and races, underscores the broad applicability of these findings, particularly among populations disproportionately affected by type 2 diabetes.”
Despite the prevalence of over 30 million individuals with type 2 diabetes in the U.S., no AID systems are currently FDA-cleared for this population. Insulet has submitted these pivotal trial results to the FDA for expanding Omnipod 5’s indications to include type 2 diabetes, anticipating a commercial launch in early 2025 pending FDA clearance. Omnipod 5 is presently FDA-cleared in the U.S. and C.E. marked for use in individuals aged two years and older with type 1 diabetes.
Dr. Francisco Pasquel, MD, MPH, of Emory University, who chaired the SECURE-T2D study, emphasized the potential of Omnipod 5 to transform type 2 diabetes management through automated insulin delivery, as evidenced by the trial’s robust improvements in glycemic outcomes and overall quality of life.
Key Highlights from the Study:
- Mean HbA1c (%) decreased significantly with Omnipod 5, dropping from 8.2% to 7.4% (a reduction of 0.8%).
- Participants with higher baseline HbA1c levels (≥9.0%) experienced even greater reductions, with a decrease of 2.1%.
- Improvements in HbA1c were observed across various prior insulin therapies, including multiple daily injections and basal-only insulin.
- Time in range increased significantly by 20% (4.8 hours/day), rising from 45% to 66%, driven by reductions in hyperglycemia.
- Time below 54 mg/dL and time below 70 mg/dL were non-inferior, demonstrating no increased risk of hypoglycemia with improved glycemic control.
- Insulin usage decreased from 0.80 U/kg/day to 0.57 U/kg/day, representing an average reduction of 23 U/day.
- Participants reported a substantial reduction in diabetes distress, as measured by individual surveys (T2-DDAS).
The trial, one of the most diverse in diabetes technology, involved 305 participants from 21 U.S. sites, including a significant representation of Black and Hispanic individuals. It assessed Omnipod 5’s efficacy across different insulin regimens and included participants using GLP-1 receptor agonists and continuous glucose monitoring (CGM).
The outcomes underscore Omnipod 5’s potential to revolutionize type 2 diabetes care and validate its effectiveness as a safe and innovative treatment option.
