| 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
|
|
|
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. |