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Insulet Highlights New Omnipods 6 Data Advancing Fully Closed-Loop AID Systems Designed for Diabetes Care

Insulet Reveals New Data Supporting Breakthrough Omnipod® 6 and Fully Closed-Loop AID Systems

Insulet Corporation has unveiled new clinical findings supporting the next generation of diabetes technology. The results highlight the potential of Fully Closed-Loop AID Systems and the company’s investigational Omnipod 6 platform to improve outcomes while reducing daily management effort.

The data comes from the STRIVE pivotal trial and the EVOLUTION 3 feasibility study. Researchers presented the findings at the American Diabetes Association (ADA) 86th Scientific Sessions in New Orleans.

The studies demonstrated improvements in glucose control across different age groups and diabetes types. In addition, the results reinforced Insulet’s commitment to making diabetes management simpler and more accessible.

New Studies Show Improved Glucose Control

The STRIVE trial evaluated the safety and effectiveness of the next-generation Omnipod 6 algorithm. The study involved 132 participants with type 1 and type 2 diabetes across the United States.

Researchers found that Omnipod 6 improved time in range and time in tight range compared with Omnipod 5. Moreover, participants maintained strong glycemic outcomes while using fewer daily boluses. The study reported no severe hypoglycemia events or diabetic ketoacidosis cases.

“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 EVOLUTION 3 study evaluated Insulet’s breakthrough Fully Closed-Loop AID Systems approach for adults with type 2 diabetes. Participants achieved 64% time in range and reduced daily insulin requirements without weight gain. Additionally, most participants reported high satisfaction and lower treatment burden.

The findings support Insulet’s broader development strategy. The company recently launched the EVOLVE pivotal trial and continues preparations for a planned FDA submission in 2027, followed by a potential commercial launch in 2028.

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News Source: Businesswire.com