Acton, Mass. — Insulet Corporation said new clinical results support its next-generation tubeless Automated Insulin Delivery systems, including Omnipod 6 and a fully closed-loop system for people with type 2 diabetes.
The company said results from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study were presented at the American Diabetes Association 86th Scientific Sessions in New Orleans. Insulet said the data showed improved glucose control while reducing daily effort for people with diabetes.
“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 Vice President 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 STRIVE pivotal trial evaluated the safety and efficacy of the next-generation Omnipod 6 algorithm. The randomized, crossover study included 132 participants across the United States, including 98 with type 1 diabetes and 34 with type 2 diabetes. The type 1 cohort included children and adults ranging from age 2 to 70.
Participants were randomized to use either the Omnipod 6 algorithm at the 100 mg/dL Target Glucose or the Omnipod 5 System at the 110 mg/dL Target Glucose for four weeks, followed by crossover to the alternate system for another four weeks. Participants then entered a Bolus Optional Phase to evaluate whether outcomes could be maintained with reduced user interaction.
Insulet said Omnipod 6 showed improved time in tight range, defined as 70–140 mg/dL, compared with Omnipod 5. Among participants with type 1 diabetes ages 14 and older, time in tight range was 54% with Omnipod 6 compared with 47% for Omnipod 5. Among participants with type 2 diabetes, time in tight range was 48% with Omnipod 6 compared with 43% for Omnipod 5.
The study also showed improved time in range, defined as 70–180 mg/dL. Among participants with type 1 diabetes ages 14 and older, time in range was 77% with Omnipod 6 compared with 73% for Omnipod 5. Among participants with type 2 diabetes, time in range was 76% with Omnipod 6 compared with 73% for Omnipod 5.
The company said the safety profile was maintained, with time below 54 mg/dL and below 70 mg/dL found to be non-inferior. No cases of diabetic ketoacidosis or severe hypoglycemia were reported.
During the Bolus Optional Phase, participants maintained strong glucose outcomes while bolusing less. Participants with type 1 diabetes ages 14 and older had 76% time in range and 54% time in tight range with 2.2 fewer boluses per day. Participants with type 2 diabetes had 74% time in range and 46% time in tight range with 2.5 boluses per day.
Insulet said the findings suggest Omnipod 6 may be especially helpful for people with diabetes who do not always bolus. The company plans to further test that approach in the upcoming STRIVE 2 study, which will evaluate Omnipod 6 among people who bolus fewer than four times per day and are not meeting clinical targets for HbA1c.
Insulet also reported results from EVOLUTION 3, a pre-pivotal study evaluating the company’s fully closed-loop system for adults with type 2 diabetes. The study enrolled 36 adults ages 18 to 75 with type 2 diabetes using insulin and with HbA1c below 14%. The company said participants had high baseline use of continuous glucose monitoring and a baseline HbA1c of 8.1%.
The fully closed-loop system delivered 64% time in range, a 12% improvement, with low hypoglycemia of 0.15%. Total daily insulin was reduced from 86 units to 58 units with no weight gain. Insulet said 86% of participants reported being satisfied or highly satisfied and reported reduced burden with the system.
