Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT06460558
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
* For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
* Having a Health Care insurance."" "
Exclusion Criteria:
* Patient already involved in another experimental study
* Patient in a particular situation deemed incompatible with the study by the investigator
* Patient living in a department other than Alpes-Maritimes or Var
* Pregnant women
* Presence of a contraindication to physical activity
* Patient with linguistic or psychological incapacity to understand written information
* Patient refusing to give consent
* Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06460558
Study Brief:
Protocol Section:
NCT06460558