Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D

Sponsor
Insulet Corporation
Study ID
NCT07593625
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Omnipod M System — DEVICE
    Participants will use the Omnipod M System
  • Omnipod S — DEVICE
    Participants will use the Omnipod S System

Study Details

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Key Dates

First listed
May 18, 2026
Start date
May 25, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adults with T1D using Omnipod M
  • Experimental: Adults and pediatrics with T1D using Omnipod S

Primary Outcome Measure

Percentage of time <54 mg/dL [ Time Frame: 72-hour Omnipod M Hotel Period ]

Central Contacts

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