Effect of a Multi-Domain Intervention On the Behaviour Problems and Cognition in Children With Hypoglycemia Unawareness In Type-1 Diabetes Mellitus -A Randomized Controlled Trial

Rationale - Behavior and Cognition in children with Hypoglycemia Unawareness (HU) in Type-1 Diabetes Mellitus (T1DM) have not been explored so far. Also, if interventions in the form of Illness Management Psychotherapy, Behavioural modifications using Functional Analysis, Education on Dysfunctional Attitudes to the children and their parents, Dietary interventions and Self-Management Techniques of Type-1 Diabetes; could be used to reverse the behavioral problems and Cognitive Impairment in children with Hypoglycemia Unawareness in T1DM, is yet to be explored.

 Objectives- We aim to assess the prevalence of Hypoglycemia Unawareness in children with Type-1 Diabetes, to evaluate the efficacy of a multi-domain intervention on the internalizing and externalizing behavior problems and cognition in children with Hypoglycemia Unawareness in Type-1 Diabetes Mellitus and to assess the Parental attitude towards children with Young-onset Diabetes Mellitus before and after interventions.

 Methods- First a cross-sectional survey will be done to assess the prevalence of Hypoglycemia unawareness in children with Type-1 DM (600 children), who are registered with the “Mittayi” program in two districts- Pathanamthitta and Kottayam, by a Continuous Glucose Monitoring for 2 weeks. Then, a baseline assessment of Behaviour and Cognition will be done on all the children found to have HU. Thereafter, an RCT will be done by dividing the children (150) with HU into two groups- Intervention (75) and Standard Treatment group (75). These children will be given interventions and followed up serially for 18 months to assess the effectiveness of interventions.

 Expected Outcome- We expect that children who will be given interventions will show improvements in their Behaviour and Cognition over a period of 1.5 years. In that case, this will serve as the best model to adopt into the Standard Treatment and Care for children with T1DM to prevent damaging consequences of Hypoglcemia on the brain.