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Recruiting NCT07317102

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

Conditions: Diabetes, Type 1 Diabetes, Diabetes Mellitus

Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Enrollment: 152
Sponsor: Insulet Corporation

Location: CHU Angers Angers

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07317102). StuddyBuddy aggregates publicly available trial information.