Clinical trialNCT07521475RecruitingInterventional

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

SponsorInsulet CorporationEnrollment350Type 2 Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Southern California
Los Angeles, California, United States
Anne Peters
Recruiting
Hoag
Newport Beach, California, United States
David Ahn
Recruiting
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Kristin Castorino
Recruiting
Touro University California
Vallejo, California, United States
Jay Shubrook
Recruiting
University of Colorado Denver
Denver, Colorado, United States
Erik Kramer
Recruiting
University of South Florida
Tampa, Florida, United States
Active, not recruiting
Metabolic Research Institute
West Palm Beach, Florida, United States
Barry Horowitz
Recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Bruce Bode
Recruiting
Emory
Atlanta, Georgia, United States
Georgia Davis
Recruiting
Endocrine Research Solutions, Inc.
Rosewell, Georgia, United States
John Reed
Recruiting
Rocky Mountain Diabetes
Idaho Falls, Idaho, United States
David Liljenquist
Recruiting
Northwestern University
Chicago, Illinois, United States
Grazia Aleppo →
Recruiting
Indiana University
Bloomington, Indiana, United States
Viral Shah →
Recruiting
Joslin Diabetes Center
Boston, Massachusetts, United States
Lori Laffel
Recruiting
Henry Ford Health
Detroit, Michigan, United States
Davida Kruger
Recruiting
International Diabetes Center
Minneapolis, Minnesota, United States
Anders Carlson →
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Yogish Kudva
Recruiting
the Mount Sinai Hospital
New York, New York, United States
Carol Levy
Recruiting
Suny Syracuse
Syracuse, New York, United States
Malek El Muayed
Recruiting
Mountain Area Health Education Center
Asheville, North Carolina, United States
Casey Wells
Recruiting
Accellacare
Wilmington, North Carolina, United States
John Parker
Recruiting
Oregon Health and Science University
Portland, Oregon, United States
Rodica Busui
Recruiting
University of Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
David Huffman
Recruiting
Texas Diabetes and Endocrinology
Austin, Texas, United States
Thomas Blevins →
Recruiting
Tekton Research
McKinney, Texas, United States
Pablo Mora
Recruiting
Tekton Research
San Antonio, Texas, United States
Jara McDonald
Recruiting
Riverside Family Medicine Residency Program
Newport News, Virginia, United States
Beth Klug
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2026
Primary completion: 24 Dec 2026
Completion: 23 Sept 2027
Last update posted: 3 Aug 2026
Registered enrollment: 350
Registry id: NCT07521475

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.