French Prospective Multicentric Study in Real World

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

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.

Conditions3

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