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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT04612257
Eligibility Criteria:
Inclusion Criteria:
1. Male or female children between 2 and 13 years of age.
2. Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
3. Using insulin pump therapy for at least 3 months
4. For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose \[8, 40\] units and 0.3 ≥ units/kg/day.
5. Most recent (in the last 6 months) HbA1c ≤ 12%.
Exclusion Criteria:
1. Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
2. Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
3. Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
13 Years
Study:
NCT04612257
Study Brief:
Protocol Section:
NCT04612257