Insulet Advances Fully Closed-Loop System for Type 2 Diabetes

Insulet has reported encouraging early clinical data for its fully closed-loop insulin delivery system in patients with Type 2 Diabetes. In a 24-patient study, participants using the system spent 24% more time within the target glucose range compared to those on standard injection therapy.

With the final algorithm and no bolus insulin, patients achieved an average time in range of 68%, while time below range remained extremely low. Importantly, no cases of severe hypoglycemia or diabetic ketoacidosis were reported, supporting a favorable safety profile.

The system is designed to function autonomously, eliminating the need for carbohydrate counting, manual dosing, or clinician-led adjustments. Insulet plans to initiate a pivotal trial this year, pursue U.S. Food and Drug Administration 510(k) clearance in 2027, and target a 2028 launch. Competitors like Tandem Diabetes Care and Medtronic are advancing similar innovations.

15-03-2026