Clinical Trial

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

Study acronym: EVOLVE
Recruiting
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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
Protocol Amendment History 4 changes
notable Trial sites expanded: 19 -> 27 locations 2026-08-04
notable Trial sites expanded: 15 -> 19 locations 2026-07-03
critical Recruitment opened 2026-06-02
notable Trial sites expanded: 0 -> 15 locations 2026-06-02
Trial Details
NCT Number NCT07521475
Lead Sponsor Insulet Corporation
Collaborators: Jaeb Center for Health Research
Conditions Type 2 Diabetes Mellitus
Enrollment 350 participants
Start Date 2026-04-30
Primary Completion 2026-12-24 (estimated)
Study Completion 2027-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-03