PODD
Live News • 2h
Insulet Advances Omnipod 6 With New Clinical Data and Expanded Product Features Insulet presented new Omnipod 6 data at the ADA Scientific Sessions, with the pivotal STRIVE trial showing improved glycemic control, up to 50% more time in automated insulin delivery, and reduced bolusing in both type 1 and type 2 diabetes users.
The EVOLUTION 3 feasibility study reported gains in time in range for type 2 diabetes with a fully closed-loop version of Insulet’s automated insulin delivery system.
The company rolled out FDA-cleared updates to the Omnipod 5 algorithm, including a 100 mg/dL target glucose option and integration with Abbott’s FreeStyle Libre 3 Plus sensor. Analysts have cited an expanding product pipeline, broader sales effort, and international growth as key areas of focus.
Taken together, the new clinical data, product upgrades, and broader ecosystem integrations indicate that Insulet is sharpening its competitive position in automated insulin delivery, especially in the underpenetrated type 2 diabetes segment.
Investors may want to weigh these developments against recent share price volatility and reports from some sources that the stock is trading below certain estimates of fair value, a situation that can present potential opportunity but also reflects ongoing market uncertainty. Announcement • Jun 09
Insulet Corporation Reveals New Data Supporting Omnipod 6 And Fully Closed-Loop Automated Insulin Delivery Systems Insulet Corporation announced new clinical results highlighting the next breakthroughs in tubeless Automated Insulin Delivery (AID) systems. Results from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study, presented at the American Diabetes Association 86th Scientific Sessions in New Orleans, demonstrate meaningful improvements in glucose control for people with diabetes using Insulet’s future AID system — Omnipod 6 — and unique fully closed-loop (FCL) system for type 2 diabetes. The STRIVE pivotal trial was designed to evaluate the safety and efficacy of the next-generation Omnipod 6 algorithm. The randomized, crossover study included 132 participants across the U.S., including 98 with type 1 diabetes and 34 with type 2 diabetes. The type 1 cohort spanned a broad age range, including 29 participants aged 2 to <6 years, 36 aged 6 to <14 years, and 33 aged 14–70 years. Baseline glycemia was near recommended targets, with mean HbA1c values of 6.9% and 7.3% for type 1 and type 2 diabetes, respectively. 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 an additional four weeks. After the Crossover Phase, all participants entered a four-week or six-week Bolus Optional Phase to evaluate whether glycemic outcomes could be maintained with reduced user interaction, with a study goal of three or fewer boluses per day. The STRIVE study demonstrated clinically meaningful improvements in glycemic outcomes with Omnipod 6 during the Crossover Phase. Improved time in tight range (70–140 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 54% vs. 47% (+7 pts); Type 2 diabetes: 48% vs. 43% (+5 pts). Improved time in range (70–180 mg/dL) with Omnipod 6 vs. Omnipod 5: Type 1 diabetes (=14 years): 77% vs. 73% (+4 pts); Type 2 diabetes: 76% vs. 73% (+3 pts). Maintained safety profile: Time <54 mg/dL and <70 mg/dL were non-inferior. No instances of diabetic ketoacidosis or severe hypoglycemia. The STRIVE study demonstrated strong glycemic performance even when users bolused less during the Bolus Optional Phase. Strong time in range and time in tight range with fewer boluses: Type 1 diabetes (=14 years): 76% time in range and 54% time in tight range with 2.2 fewer boluses/day; Type 2 diabetes: 74% time in range and 46% time in tight range with 2.5 boluses per day. These findings suggest Omnipod 6 may be especially helpful for people with diabetes who do not always bolus. This will be further tested 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 shared results from EVOLUTION 3, the pre-pivotal study evaluating the safety and effectiveness of the Company’s breakthrough FCL system for adults with 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. Yet they still had high baseline HbA1c of 8.1%. Insulet’s FCL for type 2 diabetes delivered 64% time in range, a 12% improvement with low hypoglycemia (0.15%) in a diverse, intensively managed population. Total daily insulin was reduced from 86U to 58U with no weight gain. Participants also reported high satisfaction (86% satisfied or highly satisfied) and reduced burden with FCL. This data is part of the broader clinical program used to support the development of the FCL AID system designed for people living with type 2 diabetes. The EVOLUTION 2 results were shared earlier this year at the 19International Conference on Advanced Technologies & Treatments for Diabetes, and Insulet recently announced the first enrollment of participants in EVOLVE, the randomized controlled pivotal trial supporting a planned 2027 510(k) filing to the FDA and expected 2028 commercial launch. Building on this experience from FCL for type 2 diabetes, early clinical work is underway to advance the science for FCL for type 1 diabetes as well. Insulet’s Omnipod 6 and FCL System for type 2 diabetes are investigational devices. Limited by federal (or United States) law to investigational use. These products have not been reviewed by the FDA or any other regulatory agency. 
