French Prospective Multicentric Study in Real World
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-wor
| Condition(s) | Diabetes, Diabetes Mellitus, Type 1 Diabetes |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 materia |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | Insulet Corporation |
| Locations | Angers, France; Besançon, France; Bobigny, France; Bordeaux, France; Bordeaux, France; Brest, France (+18 more sites) |
| Start date | 2025-07-23 |
| NCT ID | NCT07039942 |
| Official listing | https://clinicaltrials.gov/study/NCT07039942 |