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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT00564395
Eligibility Criteria:
Inclusion Criteria:
* Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
* On insulin glargine for at least 3 months
* Age 10-25 years
* Not on medications that may affect glucose concentrations
* Hemoglobin A1C (HbA1C) of less than 9 %
* Body Mass Index (BMI) less than 95th % and more than 10th%
* Supportive family
Exclusion Criteria:
* Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
* Unable to adhere to insulin regimen
* Positive urine pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
25 Years
Study:
NCT00564395
Study Brief:
Protocol Section:
NCT00564395