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Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 4 of 24 sitesv6
  2. Study sites: 22 to 24v5
  3. Site details revised at 3 of 22 sitesv4
  4. Secondary endpoints revised (37) Site details revised at 12 of 22 sitesv3 Show 1 more changeShow less
    • Site details revised at 12 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Recruitment opened Start date changed from estimate of Feb 2026 to Mar 16, 2026 · Secondary endpoints revised (37) · Site details revised at 22 of 22 sitesv2 Show 3 more changesShow less
    • Start date changed from estimate of Feb 2026 to Mar 16, 2026
    • Secondary endpoints revised (37)
    • Site details revised at 22 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT07317102
Lead Sponsor Insulet Corporation
Conditions Diabetes, Type 1 Diabetes, Diabetes Mellitus
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov