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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07377604
Eligibility Criteria:
Inclusion Criteria:
* Age between 1 and 18 years
* Diagnosis of diabetic ketoacidosis (DKA) according to ISPAD criteria
* First documented episode of DKA
* Availability of hemoglobin measurement obtained within 0-24 hours after biochemical resolution of DKA
* Availability of documented timestamps for initiation of DKA treatment and biochemical resolution
Exclusion Criteria:
* Hyperosmolar hyperglycemic state (HHS) or mixed DKA-HHS presentation
* Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease)
* Evidence of active hemolysis documented in medical records (e.g., elevated lactate dehydrogenase, indirect hyperbilirubinemia, or low haptoglobin)
* Red blood cell transfusion administered before or during the DKA treatment period
* Missing hemoglobin measurement within the predefined post-resolution window (0-24 hours)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT07377604
Study Brief:
Protocol Section:
NCT07377604