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Using Omnipod 5 in France: one-year real-world follow-up (Optimal-B)

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

Observational Insulet Corporation · NCT07317102

This study will see if the Omnipod 5 automated insulin delivery system helps children and adults with type 1 diabetes in France improve glucose control, quality of life, and reduce acute diabetes complications over 12 months.

Quick facts

Study typeObservational
Enrollment152 (estimated)
Ages2 Years and up
SexAll
SponsorInsulet Corporation Industry-sponsored
Locations22 sites (Angers and 21 other locations)
Trial IDNCT07317102 on ClinicalTrials.gov

What this trial studies

Optimal-B is a 12-month, prospective, non-interventional follow-up of patients aged over 2 years who were newly prescribed the commercial Omnipod 5 system configured with the FreeStyle Libre 2 Plus sensor. Participants are enrolled at multiple French university hospitals and provide device data and questionnaire responses on glycemic metrics, device use, satisfaction, and quality of life. The protocol captures real-world safety signals and acute complication rates while patients use Omnipod 5 in automated mode. No experimental changes to standard care are imposed beyond collection of routine and device-derived data.

Who should consider this trial

Good fit: People with type 1 diabetes aged 2 years or older in France who were prescribed the commercial Omnipod 5 with FreeStyle Libre 2 Plus within the past year and who have never used Omnipod 5 before are ideal candidates.

Not a fit: Patients who are currently pregnant, allergic to device materials, unable or unwilling to complete follow-up, or who cannot use the FreeStyle Libre 2 Plus configuration are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could support that Omnipod 5 improves time-in-range, patient satisfaction, and reduces acute diabetes events in routine use.

How similar studies have performed: Prior clinical trials and real-world registries of Omnipod 5 and other automated insulin delivery systems have generally shown improved time-in-range and patient satisfaction, so this study builds on existing evidence.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Angers and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DiabetesType 1 DiabetesDiabetes MellitusOmnipodAutomated Insulin DeliveryPost-market Registry
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.