Insulet Begins Study of Fully Closed-Loop Automated Insulin Delivery for T2D

Insulet has enrolled the first patient in a pivotal study of its fully closed-loop (FCL) automated insulin delivery (AID) system for type 2 diabetes (T2D).

The EVOLVE study will enroll up to 350 adults at a maximum of 40 U.S. sites. The participants are between 18-75 years old living with T2D and using insulin (basal-bolus or basal-only). The company earned investigational device exemption (IDE) approval for this study from the U.S. Food and Drug Administration (FDA) in March.

This pivotal study follows a three-part series of feasibility studies to support development of Insulet’s FCL AID system. The company presented positive feasibility results at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) that showed a 24% time in range (TIR) improvement, for an average of 68%, over standard injection therapy.

“Our innovation strategy is grounded in empathy and steadfast in our mission to transform the lives of people with diabetes,” said Dr. Trang Ly, senior VP and chief medical officer at Insulet. “Enrolling the first EVOLVE study participant marks an important step toward a fully closed‑loop AID system. Powered by a novel algorithm trained on extensive real and simulated patient data to safely titrate dosing and automatically adjust insulin delivery, our fully closed-loop AID system is uniquely designed to further reduce the burden for people with type 2 diabetes and their care teams.”

In 2024, the company shared results from its landmark SECURE-T2D pivotal trial, demonstrating improved glycemic outcomes with Omnipod 5 compared with prior insulin injection or pump therapy in adults with T2D. Participants had a reduction in HbA1c from 8.2% to 7.4% and a 20% increase in TIR (from 45% to 66% or 4.8 hours daily).

Thanks to these results, Insulet became the first company to earn 510(k) clearance for an AID system (Omnipod 5) for adults with T2D. Since then, the company said it’s seen impressive adoption rates and real-world evidence of glycemic improvements, including over 80% TIR with optimized settings.

Insulet expects to submit a 510(k) to the FDA in 2027 and launch its FCL AID system for T2D in 2028.