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

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

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Type 2 Diabetes Mellitus

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Insulet Corporation

Last updated on ClinicalTrials.gov

August 3, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites