Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInsulet Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Omnipod 5
Treatment groups
152 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov