Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
Public ClinicalTrials.gov record NCT07521475. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07521475
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2026
- Primary completion
- Dec 23, 2026
- Completion
- Sep 22, 2027
- Last update posted
- Aug 2, 2026
2026 – 2027
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90022 | Recruiting |
| HOAG | Newport Beach | California | 92663 | Recruiting |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | Recruiting |
| Touro University California | Vallejo | California | 94592 | Recruiting |
| University of Colorado Denver | Denver | Colorado | 80204 | Recruiting |
| University of South Florida | Tampa | Florida | 33612 | Active, not recruiting |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | Recruiting |
| EMORY | Atlanta | Georgia | 30308 | Recruiting |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | Recruiting |
| Endocrine Research Solutions, Inc. | Rosewell | Georgia | 30076 | Recruiting |
| Rocky Mountain Diabetes | Idaho Falls | Idaho | 83404 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Indiana University | Bloomington | Indiana | 47405 | Recruiting |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Health | Detroit | Michigan | 48202 | Recruiting |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55902 | Recruiting |
| The Mount Sinai Hospital | New York | New York | 10029 | Recruiting |
| SUNY Syracuse | Syracuse | New York | 13210 | Recruiting |
| Mountain Area Health Education Center | Asheville | North Carolina | 28803 | Recruiting |
| Accellacare | Wilmington | North Carolina | 28401 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| University of Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37411 | Recruiting |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | Recruiting |
| Tekton Research | McKinney | Texas | 75072 | Recruiting |
| Tekton Research | San Antonio | Texas | 78258 | Recruiting |
| Riverside Family Medicine Residency Program | Newport News | Virginia | 23601 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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- NCT07579702: Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07521475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2026 · Synced Aug 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07521475 live on ClinicalTrials.gov.