Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults

Sponsor
Insulet Corporation
Study ID
NCT05923827
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Omnipod 5 System — DEVICE
    The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.

Study Details

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1 diabetes.

Key Dates

Start date
Sep 11, 2023
Status verified
Apr 2026
Primary completion
Aug 16, 2024
Completion
Feb 12, 2026

Study Design

Enrollment
189 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention Group
    Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor
  • No Intervention: Control Group
    Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Primary Outcome Measure

Change in HbA1c (%) [ Time Frame: Comparing intervention group with control group during the 13-week study phase ]

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