Insulet, the maker of the Omnipod 5, has announced the start of its EVOLVE pivotal study, enrolling its first participant in a trial testing a fully closed-loop automated insulin delivery (AID) system for adults with type 2 diabetes.

The system is designed to automatically adjust insulin delivery without requiring mealtime interaction or bolus announcements. Insulet says the goal is to reduce the burden on people living with diabetes while also lowering the workload for healthcare providers, particularly in primary care settings.

The EVOLVE study is a multi-center, randomized controlled trial that will enroll up to 350 adults between the ages of 18 and 75 who have type 2 diabetes and use insulin through either basal-bolus or basal-only therapy. The trial will compare Insulet's system against standard therapy, measuring both safety and efficacy.

Insulet received FDA Investigational Device Exemption (IDE) approval in March 2026 to begin the study. The EVOLVE trial follows a series of feasibility studies that produced encouraging results. Most notably, the EVOLUTION 2 study, results of which were presented in March 2026, demonstrated a time in range (TIR) of 68%.

The company also pointed to its earlier SECURE-T2D pivotal trial, in which the Omnipod 5 improved outcomes in adults with type 2 diabetes. In that 2024 trial, HbA1c dropped from 8.2% to 7.4% and TIR climbed from 45% to 66%.

The company plans to submit a 510(k) with the FDA in 2027 and launch the fully closed-loop system in 2028, while also continuing development of its next-generation Omnipod 6.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a healthcare team before making changes to your treatment.