French Prospective Multicentric Study in Real World

Launched by INSULET CORPORATION · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical study is looking at how well the Omnipod 5 System, an automated insulin delivery device, helps people with Type 1 Diabetes manage their blood sugar levels in everyday life. The study will also explore how using this system affects quality of life, patient satisfaction, and the chances of having sudden diabetes-related health problems. This research is important because it gathers real-world information about how the Omnipod 5 works outside of a controlled lab setting.

People who may join this study are those with Type 1 Diabetes who are at least 2 years old and have been prescribed the Omnipod 5 System paired with a Dexcom continuous glucose monitor (either G6 or G7). Participants should not have used the Omnipod 5 before and must be able to read and understand French, as well as complete questionnaires about their experience. The study is not open to pregnant individuals or those who have allergies to the device materials. If selected, participants will use the Omnipod 5 System as part of their usual diabetes care and share information about their blood sugar control, overall well-being, and satisfaction through regular follow-ups and questionnaires. This study aims to provide helpful insights for people living with Type 1 Diabetes and their healthcare providers.

Gender

ALL

Eligibility 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.