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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Angers
  Angers, France Recruiting
• CHU Besançon - Hôpital de Jean Minjoz
  Besançon, France Recruiting
• APHP Hopital Avicenne
  Bobigny, France Recruiting
• CHU Bordeaux - Hôpital Pellegrin
  Bordeaux, France Recruiting
• CHU Bordeaux - Hôpital St-André
  Bordeaux, France Recruiting
• CHU Brest - Hôpital de la Cavale Blanche
  Brest, France Recruiting

Study contacts

• Principal investigator: Jean-Pierre Riveline, MD, PhD — Centre Universitaire du Diabète et ses complications Hôpital Lariboisière
• Study coordinator: Trang Ly, MBBS, PhD
• Email: APClinical@insulet.com
• Phone: 978-600-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.