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

Study acronym: EVOLVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 19 → 27 locationsv5
  2. Trial sites expanded: 15 → 19 locationsv4
  3. Recruitment opened Trial sites expanded: 0 → 15 locations · Start date changed from estimate of Apr 20, 2026 to Apr 30, 2026v3 Show 2 more changesShow less
    • Trial sites expanded: 0 → 15 locations
    • Start date changed from estimate of Apr 20, 2026 to Apr 30, 2026
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Insulet Corporation
11 trials monitored
See 1 trial at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Type 2 Diabetes
2,100 trials monitored
See 102 trials at risk
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
Trial Details
NCT Number NCT07521475
Lead Sponsor Insulet Corporation
Collaborators: Jaeb Center for Health Research
Conditions Type 2 Diabetes Mellitus
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov