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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT06382350
Eligibility Criteria:
Inclusion criteria
Study group:
* type 1 diabetes
* patients aged ≥18 year
* diabetes duration ≥3 years
* regularly driving (non-professional drivers only)
* treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment
* willing to fill in the study questionnaires
* signed patient's informed consent form
Control group:
* type 1 diabetes
* patients aged ≥18 years
* diabetes duration ≥3 years
* regularly driving (non-professional drivers only)
* treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months
* willing to fill in the study questionnaires
* signed patient's informed consent form
Exclusion Criteria (for study and control groups)
* professional drivers
* pregnancy
* inability to be present at the follow-up visit
* inability to complete the study questionnaires
* participation in another clinical study within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06382350
Study Brief:
Protocol Section:
NCT06382350