Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorUniversity of Pittsburgh

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

50 Participants
are divided into 2 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