Insulet Initiates EVOLVE Study for Closed-Loop Insulin Delivery System
Insulet Corporation has commenced its pivotal EVOLVE clinical study, enrolling 350 adults for its closed-loop insulin delivery system targeting type 2 diabetes. This system aims to automate insulin delivery, potentially enhancing glycemic management for millions who require insulin therapy.
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Insulet Corporation has enrolled the first participant in the EVOLVE clinical study, which aims to assess a fully closed-loop automated insulin delivery (AID) system for type 2 diabetes. The study, receiving FDA Investigational Device Exemption approval in March 2026, will involve up to 350 adults at 40 U.S. sites.
Previous studies indicated a 24% improvement in time in range over standard therapy. Insulet's Omnipod 5 has shown reductions in HbA1c and increased time in range among users, while the company's prescriber base grew over 60% to 6,500 in 2025. Competitive pressures in the insulin pump market may affect future growth, particularly with anticipated hybrid devices entering the market soon.
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