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

NCT06488469 | Not Yet Recruiting

• 2 other identifiers: STUDY231200015D43TW009114-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.

Conditions

Type 1 Diabetes

Keywords

Hypoglycemia; Type 1 Diabetes; Parent management techniques

Outcome Measures

Primary Outcomes (8)

• Cognitive Functioning (Neuropsychological domain level)

  Change in cognitive functioning as assessed by as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery

  Baseline and after six months' intervention

• Cognitive Functioning (Index level, )

  Change in cognitive functioning Index level, visuo comprehension index() as assessed by Neuropsychological domain level, as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery

  Baseline and after six months' intervention

• Cognitive Functioning (Index level,perceptual reasoning index )

  Change in cognitive functioning Index level, percepual reasoning index() as assessed by Neuropsychological domain level, as compared to treatment as usual group measured by NIMHANS Neuropsychological Battery

  Baseline and after six months' intervention

• Cognitive Functioning (auditory and verbal learning)

  Change in cognitive functioning (auditory and verbal learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group

  Baseline and after six months' intervention

• Cognitive Functioning (memory and learning)

  Change in cognitive functioning (memory and learning) as assessed by Neuropsychological domain level, .as compared to treatment as usual group

  Baseline and after six months' intervention

• Cognitive Functioning (language)

  Change in cognitive functioning (language) as assessed by Neuropsychological domain level, .as compared to treatment as usual group

  Baseline and after six months' intervention

• Behavioural Assessment

  Change in behavioural dimensions such as 1. anxious / depressed, 1. withdrawn/ depressed, 2. somatic complaints, 3. social problems, 4. thought problems, 5. attention problems, 6. rule-breaking problems 7. aggressive behavior problems as measured by Child Behaviour checklist

  Baseline and after intervention

• Parental Attitude

  Change in parental Attitude in the domain scores on 8 domains- 1. Overprotection 2. Acceptance 3. Rejection 4. Permissiveness 5. Communication 6. Attitude towards education 7. Home management 8. Hostility

  Baseline and after six months' intervention

Study Arms (2)

intervention

EXPERIMENTAL

The interventions will be provided at regular intervals of 2 months and adherence to the interventions will be monitored. The children along with the caregivers will attend the Endocrinology OPD where they will be educated as per prepared modules by the diabetic educators and will be monitored for adherence to diet and insulin. They will also be directed to the Child Psychologist to give module- based interventions. The interventions will be provided for a period of 6 months. Follow up of patients for reinforcement of interventions will happen on 2-monthly basis.

Behavioral: Psychological Interventions for children and adolescents

Usual Care

ACTIVE COMPARATOR

Routine standard of care is given to all patients with Hypoglycemia unawareness, irrespective of the randomized group to which they belong. This include treatment of hypoglycaemia, mandatory avoidance of hypoglycaemia for 2 weeks, Review of drugs and diet every 3 months (which is routinely done at our centre) and exploring the causes of hypoglycaemia. The control group will receive education on Dietary modification, advise on individualized targets and warning signs of hypoglycemia.

Behavioral: Psychological Interventions for children and adolescents

Interventions

Psychological Interventions for children and adolescents BEHAVIORAL

Psychological Interventions for children and adolescents: * Behavioral modifications using Functional Analysis and Parent Management Techniques * Illness Management behavior - Motivational Interviewing, Cognitive Therapy to identify thinking errors posing challenges to self-management, Behavioral Modification to enhance self-management of illness, Solution focused therapy to manage identified barriers in illness -management * Managing emotional problems- Cognitive Behavioral Therapy techniques Psychological Interventions for Parents/ Caregivers: * Parent management techniques- Identification of problem behaviors/deficit * Education on Dysfunctional attitude and their effects Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications. * Individualized Treatment targets and Resetting targets

Also known as: Psychological Interventions for Parents/ Caregivers, Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications

Usual Care; intervention

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with known psychiatric disorders.
• Children who are on steroids and
• Children with documented Learning Disability from a certified psychologist.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Believers Church Medical College, Thiruvalla, Kerala, India.: collaborator

Study Sites (1)

Believers Church Medical College

Tiruvalla, Kerala, 689 103, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Psychosocial Intervention; Caregivers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Bhatia, PhD

CONTACT

+919910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot Randomized controlled trial:A cohort of 200 children with Type-1 Diabetes will be screened for Hypoglycemia Unawareness (HU) for a maximum period of 2 weeks. The prevalence of Hypoglycemia unawareness is 25% among children and adolescents with Type-1 Diabetes patients. (5) So, we expect a minimum of 50 children with HU who will be eligible for the study.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 5, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of study
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)