During the American Diabetes Association (ADA) 2026 Scientific Sessions, Insulet presented results from two clinical trials: the STRIVE pivotal trial for Omnipod 6 and the EVOLUTION 3 feasibility study for its fully closed-loop system.
The goal of the STRIVE pivotal trial was to determine the safety and efficacy of the next-generation Omnipod 6 algorithm. In a randomized crossover study of 132 people with type 1 and type 2 diabetes, the trial demonstrated improved glucose control while using Omnipod 6 compared to the Omnipod 5. In the trial, adults with type 1 diabetes improved from 73% to 77% time in range (70-180 mg/dl), and time in tight range (70-140 mg/dl) rose from 47% to 54%. The study reported no DKA or severe hypoglycemia.
Data from the STRIVE pivotal trial presented at ADA 2026, showing Omnipod 6 improved time in tight range across all age and diabetes type cohorts.
After the crossover phase, the trial moved into a Bolus Optional Phase that evaluated system performance when participants gave fewer meal boluses. The bolus-optional portion of the study suggested the system could still perform well with reduced meal bolusing. Adults with type 1 diabetes averaged fewer boluses per day while keeping strong time in range results, and people with type 2 diabetes saw similar stability. Insulet has also announced STRIVE 2, a continuation of the study targeting people who bolus less than four times a day and are not meeting HbA1c goals.
During the Bolus Optional Phase, time in range held strong even as daily boluses dropped significantly.
The second study, EVOLUTION 3, evaluated a fully closed-loop system for adults with type 2 diabetes. The system is designed to automatically manage both basal and mealtime insulin with no user settings required. The 36 participants were already using intensive insulin therapy and CGM technology. The system produced a 12-percentage-point increase in time in range, reaching 64%, while total daily insulin use decreased from 86 units to 58 units with no weight gain. 86% percent of participants reported being satisfied or highly satisfied with the system.
Insulet has already enrolled the first participants in EVOLVE, its pivotal trial evaluating a fully closed-loop system for people with type 2 diabetes. The company is targeting a regulatory submission in 2027, with a commercial launch planned for 2028.
Beyond the clinical data, Insulet highlighted several product updates, including integration with the FreeStyle Libre 3 Plus continuous glucose monitoring system and a preview of Omnipod Discover, a new data platform designed to give healthcare providers and people with diabetes deeper insights into diabetes management.
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