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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT00129259
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 1 diabetes (according to American Diabetes Association \[ADA\] criteria) within the 8 weeks prior to study entry
* Weigh at least 25 kg (55 lbs)
* Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies
* Subjects or guardian(s) willing to provide informed consent
Exclusion Criteria:
* Prior participation in a clinical trial that could potentially affect diabetes condition or immunologic status
* Participation in another investigational clinical trial within the 6 weeks prior to study entry
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
30 Years
Study:
NCT00129259
Study Brief:
Protocol Section:
NCT00129259