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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT02220257
Eligibility Criteria:
Inclusion Criteria:
1. Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
2. Age 18-35 years
3. Education with regard to intensive functional insulin therapy at the time of diagnosis
4. Patient consent to participation in the study
Exclusion Criteria:
1. Acute inflammation (serum C-reactive protein concentration (hsCRP) \>10mg/L, leukocytosis \>15x109/L, erythrocyte sedimentation rate (OB) \>30 mm/h)
2. Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
3. History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
4. Other autoimmunological diseases other than diabetes
5. Not confirming type 1 diabetes after obtaining results of autoantibodies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02220257
Study Brief:
Protocol Section:
NCT02220257