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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00206258
Eligibility Criteria:
Inclusion Criteria:
1. Age \>12 years \< 19 years
2. Have diabetes for at least 2 years and in good control (HbA1C \< 8%).
3. Be on continuous subcutaneous insulin infusion using an insulin pump.
4. Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.
5. Menstruating women must have negative pregnancy test.
6. Hemoglobin equal to or \> than 12 g/dL before each study.
7. Weight more than 44 kg.
Exclusion Criteria:
1. Age \>18 or \< 12 y at the time of study
2. Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
3. Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies)
4. Lack of a supportive family environment
5. Positive pregnancy test in menstruating young women
6. Evidence or history of chemical abuse
7. Hgb A1c \>8.0 % in a diabetic subject
8. BMI \> 90 % tile for age or \< 10 % tile for age
9. Allergy to local anesthetics (ELAMAX Cream)
10. Weight less than 44 kg
11. Children of staff members
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT00206258
Study Brief:
Protocol Section:
NCT00206258