Insulet reports positive trial data for next-generation diabetes systems

Insulet Corporation (NASDAQ: PODD) announced results from two clinical studies evaluating its next-generation automated insulin delivery systems at the American Diabetes Association's 86th Scientific Sessions in New Orleans.

The STRIVE pivotal trial tested the Omnipod 6 algorithm in 132 participants, including 98 with type 1 diabetes and 34 with type 2 diabetes across various age groups. The randomized crossover study compared Omnipod 6 at a 100 mg/dL target glucose level against the current Omnipod 5 system at 110 mg/dL over four-week periods.

Results showed improved glucose control with Omnipod 6. For type 1 diabetes patients aged 14 and older, time in tight range (70-140 mg/dL) increased to 54% versus 47% with Omnipod 5. Time in range (70-180 mg/dL) improved to 77% from 73%. Type 2 diabetes patients showed similar improvements with time in tight range at 48% versus 43% and time in range at 76% versus 73%.

The study maintained safety standards with no instances of diabetic ketoacidosis or severe hypoglycemia. During a bolus optional phase, participants achieved strong glucose control while using fewer manual insulin doses.

The EVOLUTION 3 feasibility study evaluated a fully closed-loop system for type 2 diabetes in 36 adults. Participants achieved 64% time in range, representing a 12% improvement, while total daily insulin decreased from 86 units to 58 units with no weight gain reported.

"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," said Dr. Trang Ly, Senior Vice President and Chief Medical Officer at Insulet.

The Omnipod 6 and fully closed-loop systems remain investigational devices pending regulatory review. Insulet recently initiated the EVOLVE pivotal trial supporting a planned 2027 FDA filing and expected 2028 commercial launch for the type 2 diabetes system.

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