Status:
RECRUITING
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Lead Sponsor:
Insulet Corporation
Conditions:
Diabetes
Type 1 Diabetes
Eligibility:
All Genders
2+ years
Brief 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 complicati...
Detailed Description
Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configurati...
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.
Key Trial Info
Start Date :
March 16 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT07317102
Start Date
March 16 2026
End Date
November 1 2027
Last Update
April 13 2026
Active Locations (22)
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1
CHU Angers
Angers, France, 49100
2
CHU Besançon - Hôpital de Jean Minjoz
Besançon, France, 25000
3
APHP Hopital Avicenne
Bobigny, France, 93000
4
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000