Status:
NOT_YET_RECRUITING
Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Fogarty International Center of the National Institute of Health
Believers Church Medical College, Thiruvalla, Kerala, India.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would ...
Detailed Description
As per American Diabetes Association on Standards of Medical Care in Diabetes-2020, Continuous glucose monitoring (CGM) should be considered in all children and adolescents with Type 1 Diabetes Mellit...
Eligibility Criteria
Inclusion
- 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
- Children with known psychiatric disorders.
- Children who are on steroids and
- Children with documented Learning Disability from a certified psychologist.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06488469
Start Date
July 1 2026
End Date
December 31 2026
Last Update
December 2 2025
Active Locations (1)
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1
Believers Church Medical College
Tiruvalla, Kerala, India, 689 103