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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT05078658
Eligibility Criteria:
Inclusion Criteria:
* T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria
* T1D duration for at least 1 year prior to the intervention
* continuous glucose monitor (CGM) worn \> 70% time in the month prior to the intervention
Exclusion Criteria:
* last HbA1c \< 40 or \> 70 mmol/mol
* subject has celiac disease
* daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention
* any concomitant disease possibly affecting glucose control
* any chronic medication possibly affecting glucose control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
20 Years
Study:
NCT05078658
Study Brief:
Protocol Section:
NCT05078658