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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00312156
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes for at least 12 months
* Informed consent obtained
* BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
* HbA1c equal to or less than 12.0%
Exclusion Criteria:
* Proliferate retinopathy or maculopathy
* Total daily insulin dose greater than 2.00 IU/kg
* Any condition or disease that rule out trial participation according to the judgement of the investigator.
* Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
* A life-style incompatible with trial participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT00312156
Study Brief:
Protocol Section:
NCT00312156