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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01747967
Eligibility Criteria:
Inclusion Criteria:
Pre-inclusion criteria :
* children 6-18 years old;
* adults 19-60 years old;
* patients with a likely diagnosis of T1D, defined by an hyperglycaemia with ketonuria and/or weight loss ≥5% in the last 6 months, requiring insulin therapy.
Inclusion criteria:
* presence of serum anti-GAD antibodies; and/or
* presence of serum anti-IA-2 antibodies; and/or
* for children, presence of serum IAA antibodies; and/or
* presence of T-cell autoimmune responses;
* meal test feasible within 10 weeks of diagnosis.
Exclusion Criteria:
* recipients of solid organ or hematopoietic tissue transplantations ;
* immunosuppressive therapies (anti-histamine agents are not included);
* thyroid disease treated by methimazole;
* known HIV, HBV or HCV infection;
* known progressive cancer disease;
* known primary immune deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
60 Years
Study:
NCT01747967
Study Brief:
Protocol Section:
NCT01747967