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CTRI Number  CTRI/2024/03/063628 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Behavior and Cognition in children with Type-1 Diabetes 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sangeetha Merrin Varghese 
Designation  Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala 
Affiliation  Believers Church Medical College Hospital, Kerala 
Address  Associate Professor, Dept. of Community Medicine Division of Biomedical Research Believers Church Medical College Hospital, Thiruvalla, Kerala

Pathanamthitta
KERALA
689103
India 
Phone  9447777012  
Fax    
Email  sangjithin2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeetha Merrin Varghese 
Designation  Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala 
Affiliation  Believers Church Medical College Hospital, Kerala 
Address  Associate Professor, Dept. of Community Medicine ,Division of Biomedical Research, Room no. 4, Believers Church Medical College, Kerala

Pathanamthitta
KERALA
689103
India 
Phone  9447777012  
Fax    
Email  sangjithin2011@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeetha Merrin Varghese 
Designation  Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala 
Affiliation  Believers Church Medical College Hospital, Kerala 
Address  Associate Professor, Dept. of Community Medicine ,Division of Biomedical Research, Room no. 4, Believers Church Medical College, Kerala

Pathanamthitta
KERALA
689103
India 
Phone  9447777012  
Fax    
Email  sangjithin2011@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India Ph: 91-11-26588895 / 91-11-26588980 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research. V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sangeetha Merrin Varghese  Believers Church Medical College  Research Lab, Department of Community Medicine Believers Church Medical College Kuttapuzha,Pathanamthitta, Kerala
Pathanamthitta
KERALA 
9447777012

sangjithin2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Believers Church Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi-Domain Intervention  Psychological Counselling Dietary Management Disease self Management Training Parental Attitude counselling- For a total Duration of 18 months, with Intermittent Follow-up at 3 monthly-intervals 
Comparator Agent  Standard Treatment or Treatment as Usual  Dietary management Disease self management training For a period of 18 months 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children must be on treatment with Insulin for a minimum period of 6 months.
Should be willing to have Continuous Glucose Monitoring for another 2 weeks, at the time of completion of the study.
 
 
ExclusionCriteria 
Details  Children with known psychiatric disorders. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Behavior and cognition in children with TYpe-1 DM before and after Multi-domain interventions  Behavior and cognition in children with TYpe-1 DM before and after Multi-domain interventions
At baseline
At 6m
At 12 m
and final assessment at 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Parental Attitude before and after Intervention  after 18 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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