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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT04668612
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
2. Insulin pump and CGM initiated at least 3 months prior to the recruitment.
3. Estimated HbA1c based on the 14-days CGM report above 8.5%.
4. Daily insulin dose of more than 0.5 international units per kilogram.
Exclusion Criteria:
1. Subjects with known diabetes complications.
2. Elevated tissue transglutaminase IgA antibodies in the last two years.
3. Children who developed an acute viral infections during the week preceding the recruitment.
Exclusion criteria after the Run-in period
1. Basal insulin proportion \> 55% of daily insulin dose.
2. Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
3. Estimated HbA1c \> 8.5% based on the 14-days CGM report.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT04668612
Study Brief:
Protocol Section:
NCT04668612