NCT07317102 Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
| NCT ID | NCT07317102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insulet Corporation |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 152 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 152 participants in total. It began in 2026-03-16 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Jean-Pierre Riveline, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
Frequently Asked Questions
Who can join the NCT07317102 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07317102 currently recruiting?
Yes, NCT07317102 is actively recruiting participants. Contact the research team at APClinical@insulet.com for enrollment information.
Where is the NCT07317102 trial being conducted?
This trial is being conducted at Angers, France, Besançon, France, Bobigny, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT07317102 clinical trial?
NCT07317102 is sponsored by Insulet Corporation. The principal investigator is Jean-Pierre Riveline, MD, PhD at Centre Universitaire du Diabète et ses complications Hôpital Lariboisière. The trial plans to enroll 152 participants.
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