Insulet Corporation (NASDAQ: PODD) has enrolled the first participant in a pivotal study for its fully closed-loop automated insulin delivery system designed for type 2 diabetes patients.

The EVOLVE clinical study is a multi-center randomized control trial that will enroll up to 350 adults between ages 18-75 across a maximum of 40 U.S. sites. Participants must have type 2 diabetes and be using insulin therapy. The company received Investigational Device Exemption approval from the U.S. Food and Drug Administration in March 2026.

The system uses an algorithm that automatically adjusts insulin delivery without requiring user interactions for mealtime bolusing or announcements. According to the company, this approach aims to reduce burden for both patients and healthcare providers.

"Enrolling the first EVOLVE study participant marks an important step toward a fully closed‑loop AID system," said Dr. Trang Ly, Senior Vice President and Chief Medical Officer at Insulet.

The study follows three feasibility studies that showed a 24% improvement in time in range, reaching an average of 68% compared to standard injection therapy, according to results presented at the International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona.

Insulet previously received 510(k) clearance for its Omnipod 5 automated insulin delivery system for adults with type 2 diabetes, becoming the first company to receive such approval. The company's type 2 diabetes prescriber base in the U.S. grew by more than 60% in 2025 to over 6,500 clinicians.

The company plans to submit a 510(k) filing to the FDA in 2027 and launch the fully closed-loop system for type 2 diabetes in 2028.