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Real-world follow-up of Omnipod 5 users in France

Omnipod 5 - A French Prospective Multicentric Study in Real World

Observational Insulet Corporation · NCT07039942

This project will follow people with type 1 diabetes in France who start using the Omnipod 5 automated insulin delivery system to see if it helps their blood glucose control, quality of life, and lowers acute diabetes complications over 12 months.

Quick facts

Study typeObservational
Enrollment304 (estimated)
Ages2 Years and up
SexAll
SponsorInsulet Corporation Industry-sponsored
Locations24 sites (Angers and 23 other locations)
Trial IDNCT07039942 on ClinicalTrials.gov

What this trial studies

This is a 12-month, prospective, non-interventional follow-up of children and adults (age ≥2 years) in France who are newly prescribed a commercially available Omnipod 5 system paired with a Dexcom G6 or G7 sensor. Data collection includes device-derived glycemic metrics, questionnaires on quality of life and satisfaction, reported acute diabetes complications, and device usage patterns. Patients continue routine care at participating centers and provide consent for use of their device and questionnaire data; there is no experimental intervention or randomization. The study is multicentric and sponsored by Insulet Corporation with enrollment at several French university hospitals.

Who should consider this trial

Good fit: Ideal candidates are people with type 1 diabetes aged 2 years or older in France who have never used Omnipod 5 before and have been newly prescribed a commercially available Omnipod 5 configuration paired with a Dexcom G6 or G7 sensor, are covered by local social security, and can complete French questionnaires and be contacted by email/phone.

Not a fit: Patients who are already using Omnipod 5, are currently pregnant, have allergies to device materials, cannot be followed by the same site, or cannot complete French questionnaires or provide contact information are not eligible and would not benefit from participation.

Why it matters

Potential benefit: If successful, the study could demonstrate whether Omnipod 5 use in routine practice is associated with better glucose control, improved quality of life, and fewer acute complications for people with type 1 diabetes.

How similar studies have performed: Randomized trials and real-world registries of automated insulin delivery systems, including prior Omnipod 5 reports, have shown improvements in time-in-range and patient satisfaction, so the approach builds on evidence already observed in other settings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient with T1D aged ≥ 2 years.
* Patient prescribed a commercially available configuration of the Omnipod 5 System using a Dexcom sensor (Dexcom G6 or Dexcom G7).
* 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.
* Patient or legal guardian (for minors) is not able to understand and complete electronic questionnaires.
* Adult under guardianship, curatorship or tutorship.
* Adult otherwise deprived of liberty.

Where this trial is running

Angers and 23 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 DiabetesDiabetes MellitusType 1 DiabetesOmnipodAutomated Insulin DeliveryRegistry
Last reviewed 2026-06-10 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.