ACTON, Mass. — Insulet Corp. has enrolled the first participant in a pivotal clinical study evaluating its fully closed-loop automated insulin delivery system for adults with type 2 diabetes, advancing a technology designed to reduce daily treatment burden and simplify care for patients and clinicians.
The study, known as EVOLVE, is intended to demonstrate the safety and efficacy of Insulet’s fully closed-loop system compared with standard therapy. The system uses a proprietary algorithm to automatically adjust insulin delivery without requiring mealtime announcements or user-initiated bolusing.
Insulet, the maker of the Omnipod line of tubeless insulin pump products, said the technology is designed to improve glycemic outcomes while reducing the steps typically required to start, onboard and manage insulin 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 Vice President 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.”
The EVOLVE study is a multicenter randomized controlled trial that is enrolling up to 350 adults at as many as 40 sites in the U.S. Participants are between 18 and 75 years old, have type 2 diabetes and use insulin, either basal-bolus or basal-only therapy. Insulet received Investigational Device Exemption approval from the U.S. Food and Drug Administration in March 2026.
The company said the system is intended to support broader use of automated insulin delivery in primary care, where about 70% of people with type 2 diabetes are managed. By removing startup settings and reducing training requirements, Insulet said the system could help ease the workload for healthcare providers across care settings.
The pivotal study follows three feasibility studies that supported development of the fully closed-loop system. Insulet previously reported feasibility data at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona, Spain, including a 24% improvement in time in range compared with standard injection therapy, reaching an average of 68%.
Insulet has also reported progress with Omnipod 5 in type 2 diabetes. In 2024, the company released results from its SECURE-T2D pivotal trial, which showed improved glycemic outcomes with Omnipod 5 compared with prior insulin injection or pump therapy in adults with type 2 diabetes. Participants saw HbA1c fall from 8.2% to 7.4%, while time in range increased from 45% to 66%, equal to about 4.8 additional hours per day.
Those results led to 510(k) clearance for Omnipod 5 as an automated insulin delivery system for adults with type 2 diabetes. Insulet said subsequent real-world evidence has shown time in range of more than 80% with optimized settings among people with type 2 diabetes using Omnipod 5.
Insulet said its U.S. type 2 diabetes prescriber base grew by more than 60% in 2025 to more than 6,500 clinicians. However, adoption of automated insulin delivery remains below 5% among the estimated 5.5 million people with type 2 diabetes who require insulin.
The company said it 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.
