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CTRI Number  CTRI/2024/05/067951 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of psychological and dietary counseling on the behavior of children with Type-1 Diabetes Mellitus.  
Scientific Title of Study   Effect of a Multidomain Intervention on the Behaviour Problems and Cognition in children with Hypoglycemia Unawareness in Type-1 Diabetes Mellitus-A Pilot Study  
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  Believers Church Medical College Hospital St. Thomas Nagar, Kuttapuzha, 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  Believers Church Medical College Hospital St. Thomas Nagar, Kuttapuzha, Thiruvalla, 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  Believers Church Medical College Hospital St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala

Pathanamthitta
KERALA
689103
India 
Phone  9447777012  
Fax    
Email  sangjithin2011@gmail.com  
 
Source of Monetary or Material Support  
PRIIIA, St. Johns Hospital, Bangalore, India Pin: 560034 
 
Primary Sponsor  
Name  Psychiatric Research Infrastructure for Intervention and Implementation in India (PRIIIA) 
Address  St. Johns Medical College Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Fogarty International  University of Pittsburg, USA 
NIH   
 
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  Dept. of Community Medicine, Research Lab, Believers Church Medical College Hospital St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala 689103
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: E108||Type 1 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi-Domain Intervention  Psychological Counselling Dietary Management Disease self Management Training for 6 months with 2 monthly follow up 
Comparator Agent  Standard Treatment or Treatment as Usual  Dietary education by Diabetic Educator 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children must be on treatment with Insulin for a minimum period of 6
months 
 
ExclusionCriteria 
Details  Children with known psychiatric disorders.
Children with known intellectual disability 
 
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
Diabetes Mellitus at the start of the study and at the end of 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of Hypoglycemia Unawareness  at the end of the screening 2-3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The bigger study on the same topic with the WISC-4 Cognition assessment tool, more objectives, larger sample size and  2 year long study has been approved by CTRI (CTRI/2024/03/063628). This will be a pilot study on only 44 patients, using readily available cognition assessment tool (Modified Mini-Mental State Examination) and for a shorter duration of 6 months.



I would like to focus on Behavioral and Cognitive Functions in Children with Young Onset Diabetes Mellitus (predominantly Type-1 Diabetes Mellitus) with a special interest in those who have Hypoglycemia Unawareness or Impaired Awareness of Hypoglycemia. I would like to implement certain structured interventions which could be beneficial in preventing behavioral and cognitive decline in such children. If these interventions prove to be beneficial, we would implement screening for Hypoglycemia Unawareness, Behavioral Screening, and Cognitive Screening for all children with Young Onset Diabetes Mellitus and then provide them with tailored interventions in the form of Psychotherapy for Children and Parents, Diabetes Education and Dietary Interventions. All these interventions when given to children and their parents in a structured, regular, and balanced manner would reduce behavioral problems and cognitive decline. 

The Govt. of India and ICMR have initiated steps to curb Type-1 Diabetes. It also established a registry in 2006 named the Young Diabetes Registry. The Govt. of Kerala has started the ‘MITTAYI’ program for early identification, comprehensive treatment and all necessary support for children and Adolescents with Type-1 Diabetes Mellitus. So, if our work proves to be beneficial, we can incorporate our early intervention strategies to tackle behavioral and cognitive problems in all such children, at the State level.


 
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