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French Prospective Multicentric Study in Real World

Study acronym: OPTIMAL-A
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion moved earlier from Oct 2027 to Jul 30, 2027v8
  2. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 24 of 24 sitesv7 Show 1 more changeShow less
    • Site details revised at 24 of 24 sites
  3. Primary and study completion pushed from May 2027 to Oct 2027v6
  4. Site details revised at 1 of 24 sitesv5
  5. Primary and study completion dates: Apr 2027 to May 2027 Site details revised at 2 of 24 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 24 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 22 to 24 · Start date changed from estimate of Jul 2025 to Jul 23, 2025v3 Show 2 more changesShow less
    • Study sites: 22 to 24
    • Start date changed from estimate of Jul 2025 to Jul 23, 2025
  2. Primary and study completion dates: Apr 2, 2027 to Apr 2027 Start date: Jul 1, 2025 to Jul 2025 · Site contacts updated at 22 of 22 sitesv2 Show 2 more changesShow less
    • Start date: Jul 1, 2025 to Jul 2025
    • Site contacts updated at 22 of 22 sites
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.
Trial Details
NCT Number NCT07039942
Lead Sponsor Insulet Corporation
Conditions Diabetes, Diabetes Mellitus, Type 1 Diabetes
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov