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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT04977635
Eligibility Criteria:
Inclusion Criteria:
1. Type 1 diabetes determined by either autoantibodies or based on clinical and historical data or both
2. At least 5 years (1825 days) of type 1 diabetes
3. Minimum age 16 years
4. Treated for type 1 diabetes at a diabetes center participating in this study
5. Subject understands study protocol and agrees to comply with it and has been able to read the patient information sheet, has had time to ask questions and get answers and gives signed informed consent.
Exclusion Criteria:
1. Non-type 1 diabetes
2. Patients with a duration of type 1 diabetes below 5 years
3. Patients under the age of 16 years
4. Pregnancy and breastfeeding, until 3 months (12 weeks) after childbirth or breastfeeding
5. On experimental medication or participating in other studies with conflicting goals and schedules
6. Diseases or conditions that the investigator/physician believes to be a contraindication to participate
7. Unwilling to be informed on incidental findings.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04977635
Study Brief:
Protocol Section:
NCT04977635