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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01718093
Eligibility Criteria:
Inclusion Criteria:
* Age of 13 to 18 years
* HbA1c \>7.5% but \<10%
* Subjects must be on intensive insulin management
* Tanner stage greater than or equal to 4
* Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin
* C-peptide \> 0.6 ng/ml
Exclusion Criteria:
* Type 2 diabetes
* History of any other chronic condition (except hypothyroidism stable on medications)
* Actively taking medications that may affect glucose excursions (steroids or oral contraceptives)
* Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test
* An unsupportive family environment and pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT01718093
Study Brief:
Protocol Section:
NCT01718093