clinical trial · NCT07521475
Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
Type 2 Diabetes MellitusDevice: Omnipod M System with study CGMStandard Therapy plus study CGM
brief 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
started
Apr 20, 2026
primary completion
Dec 24, 2026
completion
Sep 23, 2027
last updated
Apr 14, 2026
official title
EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol