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

Study acronym: EVOLUTIONT1D
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 30, 2026 → Dec 31, 2026
Primary endpoints added 5 → 9 primary endpoints
See other at-risk trials from Insulet Corporation

Record History

  1. Secondary endpoints shortened, about 89 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Primary endpoint(s) modified Recruitment opened · Enrollment increased: 40 → 80 participants · Primary completion pushed from Aug 30, 2026 to Dec 31, 2026 · 3 morev4 Show 6 more changesShow less
    • Recruitment opened
    • Enrollment increased: 40 → 80 participants
    • Primary completion pushed from Aug 30, 2026 to Dec 31, 2026
    • Completion pushed from Aug 30, 2026 to Feb 1, 2027
    • Trial arms changed: 1 → 2
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 40 to 80 · Primary endpoints: 5 to 9 · Primary completion date: Aug 30, 2026 to Dec 31, 2026 · 6 morev3 Show 9 more changesShow less
    • Enrollment target: 40 to 80
    • Primary endpoints: 5 to 9
    • Primary completion date: Aug 30, 2026 to Dec 31, 2026
    • Completion date: Aug 30, 2026 to Feb 1, 2027
    • Interventions: Omnipod M System (Device) to Omnipod M System (Device), Omnipod S (Device)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 13 to 22
    • Site details revised
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints: details revised at 2 of 13 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 1 Diabetes
853 trials monitored
See 38 trials at risk
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.
Trial Details
NCT Number NCT07593625
Lead Sponsor Insulet Corporation
Conditions Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes (DM)
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov