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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT00730392
Eligibility Criteria:
Inclusion Criteria:
* Males and females subjects with T1DM aged 3-18 years
* Positive GAD 65 and/or islet cell antibody
* HbA1c at diagnosis above 6%
* Insulin regimen with 3 injection of insulin daily (as described below)
* White blood count between 3,000-10,000 and platelets \> 100,000
* Normal ALT and AST, creatinine \< 1.8 mg/dl
* T1DM duration equal or less than 4 weeks
Exclusion Criteria:
* Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
* BMI over 85th percentile for age and gender
* Unstable household
* Unable to provide compliance with study drug, insulin and study visits,
* Evidence of psychiatric disease in the potential study subject and/or primary care taker
* And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT00730392
Study Brief:
Protocol Section:
NCT00730392