RecruitingNot ApplicableNCT07521475

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

Sponsor

Insulet Corporation

Enrollment

350 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Device: Omnipod M System with study CGM and a medical device called Standard Therapy plus study CGM for people with type 2 diabetes mellitus. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDevice: Omnipod M System with study CGM

The Omnipod M system with the study CGM

DEVICEStandard Therapy plus study CGM

Standard therapy is continuation of pre-study insulin regimen and study CGM.

Locations(15)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Touro University California

Vallejo, California, United States

University of Colorado Denver

Denver, Colorado, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endocrine Research Solutions, Inc.

Rosewell, Georgia, United States

Rocky Mountain Diabetes

Idaho Falls, Idaho, United States

Henry Ford Health

Detroit, Michigan, United States

SUNY Syracuse

Syracuse, New York, United States

Mountain Area Health Education Center

Asheville, North Carolina, United States

University of Diabetes and Endocrine Consultants

Chattanooga, Tennessee, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Tekton Research

McKinney, Texas, United States

Tekton Research

San Antonio, Texas, United States

Riverside Family Medicine Residency Program

Newport News, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07521475

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