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:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT02287532
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or type 2 diabetic patients
* Performing auto-glycaemic control (at least 2 glycemias a day)
* Treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump)
* Who have an Apple® or Androïde® Smartphone compatible, or intend to acquire one before their participation in the study
* Whose HbA1c dating of less 1 month and more than 3 months is ≥ 8%
* Who are able to understand and follow the study protocol
* Who have given their signed consent to take part in the study
* Subject affiliated to the French National Health Insurance funds or benefiting from such insurance
Exclusion Criteria:
* Age \< 18 years old
* Patients who have used the DIABEO system within 6 months before inclusion
* Participation in a clinical study within 6 months, except for the Meos (or télédiab 3) study after a participation period of 6 months
* Patients who are pregnant or who wish to become pregnant during the study.
* Patients treated with human insulin A patient pre-screening register will be set up in each centre to establish the reasons for DM1/DM2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02287532
Study Brief:
Protocol Section:
NCT02287532