- Overview:
- Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults with Type 2 Diabetes.
- Staus:
- Enrolling
- Clinical Description:
- A 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.
- Target Age/Sex:
- Male or Female 18-75
- Benefits:
- Participants will receive at no cost: study product, study materials and study-specific healthcare appointments.
- Study Length:
- 26 week initial phase, 26 week extension phase
- Link:
- ClinicalTrials.gov
