Insulet Reveals New Data Supporting Breakthrough Omnipod® 6 and Fully Closed-Loop AID Systems Designed to Improve Outcomes, Reduce Effort, and Unlock Barriers to Care

About this update from Insulet Corporation

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced new clinical results highlighting the next breakthroughs in tubeless Automated Insulin Delivery (AID) systems. The data and growing body of evidence not only confirm the impact of Insulet’s technology today—it also fuels continued investment in breakthrough innovation designed to improve outcomes, reduce daily effort, and expand access to diabetes technology. Results from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study, presented at the American Diabetes Association (ADA) 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.* “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.” Together, results from STRIVE and EVOLUTION 3 underscore Insulet’s continued commitment to building a future where managing diabetes is dramatically simpler. This progress aligns with the Company’s innovation philosophy: build technology that doesn’t just do more but demands less. STRIVE Study Overview 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 ...

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