The company shared results from its STRIVE pivotal trial and EVOLUTION 3 feasibility study. Investigators presented the outcomes at the American Diabetes Association Scientific Sessions (ADA 2026) in New Orleans. Findings demonstrated meaningful improvements in glucose control for people with diabetes using the investigational Omnipod 6 and a fully closed-loop system for type 2 diabetes.
Insulet offered some details on the next-generation Omnipod 6, which it expects to launch next year, at its Investor Day event in November 2025. In an interview with Drug Delivery Business News, CEO Ashley McEvoy said Omnipod 6 represents the next-generation hybrid closed-loop automated insulin delivery (AID) option for both type 1 and type 2 diabetes. It features an improved, adaptive algorithm that makes the pod even easier to use, while maintaining the same form factor as the current Omnipod 5.
Read more from the interview with McEvoy here.
The Acton, Massachusetts-based company’s fully closed-loop technology for type 2 is expected to launch in 2028. Insulet initiated the EVOLVE FDA investigational device exemption (IDE) study for the technology last month. That came on the heels of positive data from the EVOLUTION 2 feasibility study evaluating FCL for type 2. The company hopes to further improve glycemic outcomes with less burden for users across diverse settings. That includes eliminating user interactions for bolusing and mealtime announcements. It also helps eliminate settings to start and onboard users.
“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 Insulet SVP and Chief Medical Officer, Dr. Trang Ly,. “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.”
A look at the Insulet Omnipod 6 findings
The STRIVE pivotal trial evaluated the safety and efficacy of the next-generation Omnipod 6 algorithm. Insulet’s randomized crossover study included 132 participants across the U.S. That included 98 people with type 1 diabetes and 34 with type 2 diabetes. The type 1 cohort spanned a broad age range, including 29 participants aged between 2 and <6 years, 36 aged 6 to <14 years, and 33 aged 14–70 years.
Baseline glycemia came in near recommended targets. Mean HbA1c values totaled 6.9% and 7.3% for type 1 and type 2 diabetes, respectively.
Investigators randomized participants to either Omnipod 6 at the 100 mg/dL target glucose or Omnipod 5 at 110 mg/dL for four weeks. Then, patients crossed over to the alternate system for an additional four weeks. After the crossover phase, all participants entered a four-week or six-week bolus optional phase. This evaluated the maintenance of glycemic outcomes with reduced user interaction, aiming for three or fewer boluses per day.
STRIVE demonstrated clinically meaningful improvements in glycemic outcomes with Omnipod 6 during the crossover phase. Patients reported improved time in tight range with Omnipod 6. Type 1 time in range came in at 54% with Omnipod 6 compared with 47% for Omnipod 5. For type 2, it was 48% and 43%, respectively.
Omnipod 6 also lead to improved time in range and maintained safety, with no instances of diabetic ketoacidosis (DKA) or severe hypoglycemia.
Time in range and tight range findings also supported Omnipod 6 in the bolus optional phase with fewer boluses.
Insulet said its findings suggest the potential helpfulness of Omnipod 6 for people with diabetes who do not always bolus. The company plans to evaluate it further in the upcoming STRIVE 2 study. That looks at Omnipod 6 among people who bolus fewer than four times per day and are not meeting clinical targets for HbA1c.
Fully closed-loop findings provide a further boost
Insulet also shared findings from EVOLUTION 3, its pre-pivotal study for the fully closed-loop system in type 2 diabetes.
EVOLUTION 3 enrolled a demographically diverse cohort comprised of 36 participants (adults aged 18-75 years old) with type 2 diabetes using insulin with HbA1c <14%. Participants were intensively managed with basal-bolus therapy and had high baseline utilization of continuous glucose monitoring. Insulet said they still had a high baseline HbA1c of 8.1%.
The fully closed-loop algorithm delivered 64% time in range and a 12% improvement in low hypoglycemia (0.15%). Total daily insulin decreased from 86U to 58U with no weight gain. Participants also reported high satisfaction (86% satisfied or highly satisfied) and reduced burden with the advanced technology.
Data from EVOLUTION 3 serves as part of a broader clinical program to support fully closed-loop AID. Insulet plans to use the upcoming EVOLVE study results to support a planned 2027 FDA 510(k) filing, with eyes on the 2028 launch. It also has work underway to advance the science for fully closed-loop technology in type 1 diabetes.
