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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT02938806
Eligibility Criteria:
Inclusion Criteria:
* Age 7 to 17 years
* Diagnosis of diabetes will be defined by current American Diabetes Association criteria ° (fasting glucose \> 126 mg/dl, 2 hour OGTT glucose \> 200 mg/dl; random glucose \> 200 with symptoms of hyperglycemia; or HbA1c \> 6.5%)
* Diabetes duration \< 3 years
* Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity)
* Adult caregiver willing to actively support study participation
* Signed parental informed consent form and minor child informed assent form
Exclusion Criteria:
* Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT02938806
Study Brief:
Protocol Section:
NCT02938806