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 @ 1:01 PM
Ignite Modification Date:
2025-12-24 @ 1:01 PM
NCT ID:
NCT01279161
Eligibility Criteria:
Inclusion Criteria:
* children of Polish origin
* diagnosed with type 1 diabetes (defined according to the ADA 2010)
* treated with insulin therapy for at least 1 year
* aged ≥ 6 \< 18 years
* receiving the same treatment regimen for at least one year
* insulin requirement of \> 0.5 U/kg/daily
Exclusion Criteria:
* no consent given by parents/guardians
* chromosome disorders
* autoimmune diseases
* coeliac disease (biopsy-proven)
* thyroid hormone disorders (but not the presence of antithyroid antibodies)
* treatment that might influence body weight
* newly diagnosed diabetes (either type 1, 2, 3 or other types of diabetes)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01279161
Study Brief:
Protocol Section:
NCT01279161