About this trial
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 bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Children with known psychiatric disorders.
Children who are on steroids and
Children with documented Learning Disability from a certified psychologist.
Trial design
Treatments tested in this trial
- Psychological Interventions for children and adolescents
Treatment groups
Sponsors and collaborators
University of Pittsburgh
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Believers Church Medical College, Thiruvalla, Kerala, India.
Collaborator