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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT06488469
Eligibility Criteria:
Inclusion Criteria:
* Children should be between 6-16 years of age.
* Children must be having Hypoglycemia Unawareness as documented by Continuous Glucose Monitoring. (Blood sugar \<70 mg/dl without symptoms)
* Children must be on treatment with Insulin for a minimum period of 6 months
* The care giver/parent must give written informed consent for the child and himself/herself and the child should give assent.
Exclusion Criteria:
* Children with known psychiatric disorders.
* Children who are on steroids and
* Children with documented Learning Disability from a certified psychologist.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT06488469
Study Brief:
Protocol Section:
NCT06488469