Insulet Data Supports Omnipod 6, Fully-Closed Loop AID Systems

Insulet released new clinical results highlighting the next breakthroughs in its tubeless automated insulin delivery (AID) systems.

Results from the STRIVE pivotal trial and EVOLUTION 3 feasibility study were presented at the American Diabetes Association (ADA) 86th Scientific Sessions. They showed meaningful improvements in glucose control for people with diabetes using Insulet’s future Omnipod 6 AID system, a fully closed-loop (FCL) system for type 2 diabetes.

The STRIVE trial evaluated the Omnipod 6 algorithm’s safety and efficacy. The 132-patient study included 98 subjects with type 1 diabetes and 34 with type 2 diabetes. Baseline glycemia was near recommended targets, with mean HbA1c values of 6.9% and 7.3% for type 1 and type 2 diabetes, respectively.

The results also demonstrated improved time in tight range (70-140 mg/dL) and improved time in range (70-180 mg/dL) with Omnipod 6 vs. Omnipod 5. The study also showed strong glycemic performance even when users bloused less during the Bolus Optional Phase.

The EVOLUTION 3 study data showed fully closed-loop for type 2 diabetes improved time in range and reduce daily insulin with no weight gain. The FCL for T2D delivered 64% time in range, a 12% improvement with low hypoglycemia (0.15%). Total daily insulin was reduced from 86U to 58U with no weight gain.

“Omnipod 6 represents one of our biggest steps forward yet, with greater personalization and responsiveness to hyperglycemia, by delivering up to 50% more automated insulin, as shown in the STRIVE results,” said Dr. Trang Ly, MBBS, FRACP, PhD, senior VP and chief medical officer at Insulet. “Our fully closed-loop system for type 2 diabetes is intentionally designed to unlock barriers to AID by managing mealtime insulin and simplifying workflows to expand clinic adoption. Strong results from EVOLUTION 3 bring us one big step closer to making fully closed-loop for type 2 diabetes a reality.”

The company recently enrolled the first patients in EVOLVE, the pivotal trial supporting a planned 2027 510(k) filing to the FDA and expected 2028 commercial launch.