NCT07521475

Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Device: Omnipod M System with study CGM	The Omnipod M system with the study CGM
DEVICE	Standard Therapy plus study CGM	Standard therapy is continuation of pre-study insulin regimen and study CGM.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-12-24
• Completion: 2027-09-23
• First posted: 2026-04-13
• Last updated: 2026-04-14

Regulatory

• FDA-regulated device study