Insulet Corporation (NASDAQ: PODD) presented results from its EVOLUTION 2 study for a fully closed-loop automated insulin delivery system designed for adults with type 2 diabetes. The study was presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona, Spain.

The multicenter feasibility study included 24 adults from New Zealand, aged 16-70 years with type 2 diabetes. Participants had lived with the condition for an average of 16 years and used various insulin delivery methods including basal-bolus or basal-only regimens via pumps or injections.

When using the final algorithm version without boluses, participants achieved 68% time in range, representing a 24% improvement over standard injection therapy. Time below range remained at a median of 0.14% below 70 mg/dL, which is below the American Diabetes Association's recommended threshold of less than 4%. The study reported no severe hypoglycemia or diabetic ketoacidosis events.

More than 90% of study participants chose to continue into the ongoing extension phase of the trial. The benefits were observed across diverse participant characteristics including sex, ethnicity, baseline HbA1c, and body mass index.

The EVOLUTION 2 study builds on the company's 2024 EVOLUTION 1 feasibility study, which showed improvements in time in range from 52% to 65% without boluses in adults with type 2 diabetes.

Insulet plans to begin its pivotal study called EVOLVE in 2026 to support a 510(k) filing in 2027 and commercial launch in 2028. The fully closed-loop system remains an investigational device limited to investigational use and has not been reviewed by the FDA.