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

NCT07521475 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-06-01

No results posted yet for this 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

Conditions

Interventions

DEVICE

Device: Omnipod M System with study CGM

The Omnipod M system with the study CGM

DEVICE

Standard Therapy plus study CGM

Standard therapy is continuation of pre-study insulin regimen and study CGM.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Insulet Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-12-24
Completion
2027-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521475 on ClinicalTrials.gov