| CTRI Number |
CTRI/2017/10/009984 [Registered on: 03/10/2017] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Modifying diet and insulin regimes in children with diabetes to improve blood sugar control |
|
Scientific Title of Study
|
Optimizing diet and insulin regimes in children with Type 1 Diabetes in low-resource settings: An RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Jain |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 3063, 3rd floor, Teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9810167265 |
| Fax |
|
| Email |
drvandanajain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Jain |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 3063, 3rd floor, Teaching block, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
9810167265 |
| Fax |
|
| Email |
drvandanajain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Jain |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 3063, 3rd floor, Teaching block, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
9810167265 |
| Fax |
|
| Email |
drvandanajain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, Ministry of Health and Family Welfare |
|
|
Primary Sponsor
|
| Name |
DHR |
| Address |
Ministry of health and family welfare |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Delhi |
All India Institute of Medical Sciences Ansari Nagar New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Jain |
AIIMS |
Division of pediatric Endocrinology, Department of Pediatrics
South
DELHI |
9810167265
drvandanajain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 1 diabetes, (1) ICD-10 Condition: E10||Type 1 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Healthy balanced low GI snacks and carbohydrate counting |
a. Substituting unhealthy with easy to prepare balanced mid-meal snacks with low glycemic load
b.Teaching the skill of counting the carbohydrates in major meals and adjusting the dose of bolus insulin accordingly
Duration of the intervention: 6 months
Intervention arm: Healthy balanced low GI snacks and carbohydrate counting
At enrolment
• One to one intensive dietary counseling using videos, pamphlets, and posters on knowledge about disease, relationship between insulin and diet, concept of balanced healthy diet, macronutrients and micronutrients, concepts of glycemic index and load (GI and GL).
• Individualized diet chart based on age, height, weight, activity and insulin dose, will be given.
• Home based 7 days healthy cyclic menu with six-meal pattern in accordance with the family’s dietary preferences and affordability will be provided.
• A recipe book (as mentioned in preparatory phase) containing detailed recipes (with amounts of ingredients in terms of household measures, method of preparation, portion size
• and amount of carbohydrate, fat, protein and energy per serving) for healthy balanced low GI snacks for breakfast, school tiffin and mid-meal snacks will be given.
• Most of the recipes will be simple and easy to prepare as they will be based on modification of the traditional home-cooked snacks (reducing their glycemic load by substitution addition of whole grains, millets, pulses and vegetables). The amount/ ratio of raw ingredients to be taken using household measures, and cooking techniques will be explained by the dietician.
• A CD/ USB drive containing the demonstration video for the recipes will be given.
• Carbohydrate counting of home cooked, restaurant and packaged Indian food items will be taught using interactive pictorial modules, quizzes and games.
• Parents and children will be taught to fill the dietary diary and record the carbohydrate count of meals and snacks
In follow-up
• Bi-weekly telephonic reminders by the dietician, review of methods of preparation of the low GI recipes at home, remedial action and problem solving
• Practice and assessment sessions for carbohydrate counting every 4 weeks in small groups of up to 6 children and their parents, reinforcement of compliance with the dietary prescription, including following the recipes strictly
• Six weekly clinic visits: Review and counseling by pediatric endocrinologist, diabetes nurse and clinical psychologist, checking compliance to diet using a short questionnaire and taking remedial action, hbA1c at 3 mo
|
| Comparator Agent |
Standard Diabetes Management Group |
Routine clinical care including diabetes education and diet counseling
At enrolment
• Routine clinical care including diabetes education
• One to one and group dietary counseling with explanation of concept of food exchanges (1 exchange of carbohydrate, protein and fat equals 15g, 7g, and 5g, respectively) to parents
• Dietary prescription according to the child’s recommended dietary allowance with list of food exchanges
In follow-up
• Six weekly clinic visits: Review and counseling by pediatric endocrinologist, diabetes nurse and clinical psychologist, hbA1c at 3 mo
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
a. Children aged 8 - 16 years with Type 1 Diabetes
b. Diagnosed at least 1 year ago
c. Enrolled in and under regular follow-up at Pediatric Endocrinology Clinic, AIIMS
d. Resident of Delhi, NCR
e. On minimum of 4 daily injections of insulin (long-acting: NPH or glargine or detemir and short acting: regular, lispro, aspart or glulisine)
f. Measuring blood glucose at home regularly
|
|
| ExclusionCriteria |
| Details |
a. Celiac disease
b. Both parents illiterate
c. Inability to communicate well in both Hindi and English
d. Those on insulin pump (continuous subcutaneous insulin infusion)
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absolute reduction in hbA1c percentage from baseline |
At 6 months after enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Three day continuous glucose monitoring, analysis of proportion of time spent in euglycemia, hyper and hypoglycemia
|
6 months |
Assessment of compliance with prescribed diet, total caloric intake and proportion from carbohydrates, fats and proteins by 3 day dietary recall, food frequency questionnaire and dietary diary
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
28/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In children aged 8-16 years with type 1 diabetes, we propose to study the efficacy of two interventions in improving their glycemic control. 1. Standardized, healthy and easy to prepare balanced low glycemic load snacks as mid-meals 2. Teaching the skill of counting the carbohydrates in major meals and adjusting the dose of insulin accordingly.
India has 18% of the world’s diabetic children. Although significant advances have been made in the technology for diabetes care including use of continuous subcutaneous insulin infusion by pump and continuous glucose monitoring, our children remain untouched by these due to the high cost. However, detailed patient education and intensive dietary counseling can be effective strategies in low-cost settings that can help in improving diabetes control.
Our hypothesis is that together these two interventions can help in achieving a reduction in HbA1c and reducing episodes of hypo and hyper-glycemia. The recruitment of children with type 1 diabetes has begun from January 2018. The site is Department of Pediatrics, AIIMS, Delhi. We have modified the age to 6-18 years, and children staying in the neighbouring cities who are willing for regular follow-up are also eligible for enrollment. |