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NCT07521475 · ClinicalTrials.gov registry record · NA
Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
A NA study, sponsored by Insulet Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
NCT07521475: Recruiting NA study, sponsored by Insulet Corporation.
NCT07521475 is a NA study that is actively recruiting participants, run by Insulet Corporation. The registered enrollment target is 350 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07521475, a NA study, is actively recruiting participants, sponsored by Insulet Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
Study 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
Primary Outcome
Change in HbA1c (%) from baseline between the intervention and control groups
Interventions
- DEVICE Device: Omnipod M System with study CGM
- DEVICE Standard Therapy plus study CGM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2027-09-23 |
| Phase | NA |
What NCT07521475 shows while recruiting
NCT07521475 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Device: Omnipod M System with study CGM is the first listed.
NCT07521475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07521475 about?
NCT07521475 is a clinical study titled "Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes". 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 2...
What is the current status of trial NCT07521475?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2026-04-30. Estimated completion is 2027-09-23.
What interventions are being tested in trial NCT07521475?
The interventions under investigation include: Device: Omnipod M System with study CGM (DEVICE), Standard Therapy plus study CGM (DEVICE).
Who is sponsoring clinical trial NCT07521475?
This trial is sponsored by Insulet Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07521475's enrollment target sits among peer trials
350 292nd of 2000 higher than 1,699 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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