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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT06453434
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 85 years.
2. Diagnosed with T1D over one year ago.
3. Actively using FreeStyle Libre 2 (\>80% sensor activity).
4. Used FreeStyle Libre 2 for over three months.
5. Uses multiple daily insulin injections.
6. Capable of providing written informed consent.
7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.
Exclusion Criteria:
1. History of allergic reactions to materials or adhesives used in CGM devices.
2. Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
3. Current use of steroids unless part of a chronic therapy plan.
4. Daily consumption of vitamin C ≥ 500 mg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06453434
Study Brief:
Protocol Section:
NCT06453434