Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) (NCT07317102) | Clinical Trial Compass
RecruitingNot Applicable
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
France152 participantsStarted 2026-03-16
Plain-language summary
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.
Who can participate
Age range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with T1D aged ≥ 2 years.
* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
* Patient has never used the Omnipod 5 System prior to inclusion.
* Patient has not objected to the use of their personal data for this study.
* Patient or legal guardian has an email address and mobile phone number.
* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.
* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.
* Patient is covered by the local social security system
Exclusion Criteria:
* Patient is currently pregnant.
* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
* Adult under guardianship, curatorship or tutorship.
* Adult otherwise deprived of liberty.
What they're measuring
1
Change in the percentage of time in the 70 - 180 mg/dL range
Timeframe: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode