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

The Effect of a Multi-domain Intervention on the Behaviour Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus- A Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Psychological Interventions for children and adolescents

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 Mellitus to look out for Hypoglycemia Unawareness. But unfortunately, it is not done as a routine practice in India due to financial constraints. So, the aim is to explore the behavior and cognition in children with Hypoglycemia Unawareness and to find out if a multipronged strategy consisting of Psychological Interventions, Dietary Modifications, Targeted therapy and Counseling on Parental Attitude to bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.

Those children with documented Hypoglycemia Unawareness will be subjected to Behavioral and Cognition Testing using Child Behavior Checklist , Modified Mini-MMSE and a part of the NIMHANS neuropsychological battery. Parents or caregivers (especially mother) of children with Hypoglycemia unawareness will be assessed for parental attitude towards their children.

All children with Hypoglycemia Unawareness and their parents will receive the multi-domain interventions by a certified Child Psychologist in the Psychiatric Department and Trained Diabetic Educators in the Endocrinology Dept. as per the prepared modules.

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 behaviors, identification of positive opposites, reinforcement techniques.
• Education on Dysfunctional attitude and their effects and communication techniques, conflict management and problem solving strategies.

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 by maintaining a structured log book and cutting down on insulin at night, etc.
• Warning signs of Hypoglycemia and its management.
• Self- Management techniques of Disease Condition (Behavioral strategies like goal setting, activity scheduling with respect to self-management behaviors)

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.

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.

At the end of 6 months, children in both the groups (Intervention and Control group) will be subjected to a detailed assessment of the Behavior and Cognition and Parental Attitude will be tested for the parents.

Eligibility Screening of the child to participate in the study will be based on the Inclusion and Exclusion criteria and willingness to give consent for participation in the study. Only screening by Continuous Glucose Monitoring will be done after assessing for eligibility.

The eligibility for entry into the RCT will be based on the results of the CGM monitoring for measuring Hypoglycemia Unawareness.The parents of children with Hypoglycemia Unawareness will be chosen for Psychological Counselling on Dysfunctional attitude.

Study procedure:

1. st contact - referral, screening, informed consent and Baseline assessments of age, diagnosis of type-1 DM (Time duration: 30 min)

   After regular follow-up visit with the treating doctor, if the patient fulfill all the inclusion criteria, the treating doctor will request the patient to meet the study team.

   Patient will meet the study team in a private room adjacent to the Hospital Building The junior research fellow (JRF), briefs the patient about the study and the study information sheet will be given for the detailed understanding of the process.

   If patient wishes to continue further, the JRF will screen the patient for the eligibility by using a Continuous Glucose Monitoring

   The screening will be by Continuous Glucose Monitoring, wherein a glucose monitor will be affixed to the child, for glucose readings for a maximum period of 2 weeks. There will also be a verbal process to check eligibility criteria for this study. If the patient is not eligible by not having documented Hypoglycemia Unawareness, then the participation in this study will end. (PS: Screening procedures for the study eligibility may involve the review and collection of information from patient's medical record.) If the patient has documented Hypoglycemia awareness as is assessed from the reader ( which is paired to the Glucose sensor)

   This will be followed by obtaining written informed consent from the patient's caregiver, if he considers his child's participation in theRandomized Control Trial.

   After successful entry into the study, the patient will be asked about the demographic details including medical, treatment history.

   Baseline assessments to assess Behavior, cognitive functions and parental attitude will be done by the Psychologist. Time duration : 140 minutes

   After this patient will be randomly allotted to either the Multi-domain Intervention Group or Treatment as-usual group.

   Contact details like phone number will be collected to monitor the practices and inform follow-up visits. The name and phone number of 1 to 3 people, related to patient whom the study team could contact in case of a missed appointment when researchers are unable to reach patient after several attempts or in case of an emergency. This person will know that the patient is participating in the study.

2. nd and 3rd contacts: Multi-domain Intervention after 2 months and 4 months (Time duration for re-inforcement of interventions : 30 minutes/ contact)

If the participant is in the Treatment as-usual group, he/she will be asked to continue coming for check-ups every 3 months.

Final assessment: After 6 months of intervention to assess Behavior, cognitive functions and parental attitude will be done by the Psychologist.

After the study period the participants will be appropriately directed towards the future care.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vishwajit L Nimgaonkar, MD, PhD; Phone Number: 4127265164; Email: vishwajitnl@upmc.edu
• Study Contact Backup: Name: Triptish Bhatia, PhD; Phone Number: +919910107210; Email: trb16@pitt.edu

Study Locations

• India
  • Kerala
    • Tiruvalla, Kerala, India, 689 103
      • Believers Church Medical College
      • Contact: Sangeetha M Varghese, MD; Phone Number: +919910107210; Email: sangjithin2011@gmail.com
      • Contact: Pradeep Johnson, MD; Phone Number: +917892673938; Email: johnson.pr@stjohns.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; 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; 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; Other Names: 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
Active Comparator: Usual Care; 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; 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; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Fogarty International Center of the National Institute of Health; Believers Church Medical College, Thiruvalla, Kerala, India.
• Investigators: Principal Investigator: Vishwajit L Nimgaonkar, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hypoglycemia; Type 1 Diabetes; Parent management techniques
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus, Type 1; Health Care Facilities Workforce and Services; Psychotherapy; Behavioral Disciplines and Activities; Health Personnel; Caregivers; Psychosocial Intervention
• Other Study ID Numbers: STUDY23120001; 5D43TW009114-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: One year after publication of study
• IPD Sharing Access Criteria: For individual participant data, meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No