Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes (NCT07521475)
EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of Southern California — Los Angeles, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- University of Southern California — Los Angeles, California
- HOAG — Newport Beach, California
- Sansum Diabetes Research Institute — Santa Barbara, California
- Touro University California — Vallejo, California
- University of Colorado Denver — Denver, Colorado
- University of South Florida — Tampa, Florida
- Metabolic Research Institute — West Palm Beach, Florida
- EMORY — Atlanta, Georgia
- Atlanta Diabetes Associates — Atlanta, Georgia
- Endocrine Research Solutions, Inc. — Rosewell, Georgia
- Rocky Mountain Diabetes — Idaho Falls, Idaho
- Northwestern University — Chicago, Illinois
- Indiana University — Bloomington, Indiana
- Joslin Diabetes Center — Boston, Massachusetts
- Henry Ford Health — Detroit, Michigan
- International Diabetes Center — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- The Mount Sinai Hospital — New York, New York
- SUNY Syracuse — Syracuse, New York
- Mountain Area Health Education Center — Asheville, North Carolina
- Accellacare — Wilmington, North Carolina
- Oregon Health and Science University — Portland, Oregon
- University of Diabetes and Endocrine Consultants — Chattanooga, Tennessee
- Texas Diabetes and Endocrinology — Austin, Texas
- Tekton Research — McKinney, Texas
📞 Contact the Study Coordinator
Phone: (978) 600-7000
Email: APClinical@insulet.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.