Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Insulet Corporation
152 participants
Mar 16, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.
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Interventions
The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.
Locations(22)
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NCT07317102