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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT04211220
Eligibility Criteria:
Inclusion Criteria:
* Men and women ≥ 18 years of age
* Patients with type 1 diabetes mellitus for more than 2 years
* Treated by either insulin pump for more than 6 months or multiple daily insulin injections.
* Using Freestyle Libre® for more than 3 months
* Accepting IRTA use
* Patient able to provide free and informed consent
* Patient able to provide written non-disclosure agreement
Exclusion Criteria:
* Pregnancy, breastfeeding or pregnancy project in the future 6 months
* Patients with no smart phone or internet access
* Patients legally protected (under judicial protection, guardianship or supervision)
* Patients with acute illness (psychiatric, infection, cancer,…)
* Patients using another CGM system (Enlite® or Dexcom G4®)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04211220
Study Brief:
Protocol Section:
NCT04211220