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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT05899166
Eligibility Criteria:
Inclusion Criteria:
* Children aged 5 to 12 years.
* Within 3 month of diabetes diagnosis.
* Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis.
* Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker \[glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin \[prior to first insulin dose\]; age under 10 years, BMI \<95th percentile.
* Family committed and able to participate in study education and implement dietary intervention.
Exclusion Criteria:
* Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic).
* Eating disorders as assessed by Chede-Q8.
* Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables.
* Major psychiatric illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT05899166
Study Brief:
Protocol Section:
NCT05899166