| CTRI Number |
CTRI/2026/01/102241 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing glucose sensor monitoring with routine finger-prick testing to understand blood sugar changes in children with type 1 diabetes |
|
Scientific Title of Study
|
Comparison of continuous glucose monitoring plus self-monitoring of blood glucose versus self-monitoring of blood glucose alone on glycemic variability in children with type 1 diabetes - 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 Jasleen Kaur Dhillon |
| Designation |
Post Graduate first year, Department of pediatrics |
| Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
| Address |
Room no 215 RMO-A girls hostel DIZ area Gole Market Bangla sahib road New Delhi 110001, INDIA
New Delhi DELHI 110001 India |
| Phone |
7999812231 |
| Fax |
|
| Email |
jasleenkaurdhillon21@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Preeti Singh |
| Designation |
Professor in Department of Paediatrics |
| Affiliation |
Kalawati Saran Childrens Hospital |
| Address |
Room number 337 third floor Kalawati saran childrens hospital Bangla sahib road, New Delhi
New Delhi DELHI 110001 India |
| Phone |
981052515 |
| Fax |
|
| Email |
drpreetisingh3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Preeti Singh |
| Designation |
Professor in Department of Paediatrics |
| Affiliation |
Kalawati Saran Childrens Hospital |
| Address |
Room number 337 third floor Kalawati saran childrens hospital Bangla sahib road, New Delhi
New Delhi DELHI 110001 India |
| Phone |
981052515 |
| Fax |
|
| Email |
drpreetisingh3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalawati saran childrens hospital ,C-604 Connaught Place, Bangla sahib road, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Preeti Singh |
| Address |
Kalawati saran childrens hospital,C-604 Connaught Place,bangla sahib road, New Delhi 110001 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasleen Kaur Dhillon |
Kalawati Saran Childrens Hospital |
Endocrine clinic OPD Room number 108 and 109 First floor Department of paediatrics , C-604 Cannaught place, Bangla sahib road, New Delhi, 110001 New Delhi DELHI |
7999812231
jasleenkaurdhillon21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LHMC |
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 |
Intermittent scanned continuous glucose monitoring for 15 days followed by self monitoring of blood glucose |
Participants randomized to the intervention group will use an intermittently scanned continuous glucose monitoring (isCGM) system for 15 days followed by routine self-monitoring of blood glucose (SMBG) using a glucometer as per standard of care for the rest of study duration of 3 months. |
| Comparator Agent |
Self-Monitoring of Blood Glucose (SMBG) |
Participants in the comparator arm will perform self monitoring of blood glucose (SMBG) using a glucometer as per the standard of care (minimum 4 times daily) for 3 months study. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with type 1 diabetes for more than one year
On MDI regimen (basal-bolus) for more than 6 months
HbA1c between 7.0% -10.0%
Willing to use CGM/SMBG and attend follow-up for the next 3 months |
|
| ExclusionCriteria |
| Details |
DKA in the last 3 months
Cognitive/psychiatric disorders impairing adherence
Any comorbid conditions significantly affecting glycemic control
Children with anemia, hemoglobinopathies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in glycemic variability, as measured by the coefficient of variation (%CV) of glucose levels, at the end of 3 months between children with Type 1 Diabetes using intermittent scanned continuous glucose monitoring (isCGM) for 15 days followed by SMBG, versus those using SMBG alone. |
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare additional glycemic variability metrics between the intermittent scanned CGM plus SMBG group and the SMBG-only group at 3 months using structured SMBG data. The metrics to be assessed include estimated blood glucose in range (IR), defined as the percentage of readings between 70–180 mg/dL; below range (BR), defined as the percentage of readings less than 70 mg/dL; and above range (AR), defined as the percentage of readings greater than 180 mg/dL and greater than 250 mg/dL. Additionally, the study will compare the proportion of children achieving a coefficient of variation (CV) of less than 36% at the end of 3 months between the two groups. |
Three months |
To compare the change in HbA1c levels from baseline to 3 months between children with Type 1 diabetes randomized to limited (15-day) use of intermittent scanned CGM followed
by SMBG versus those with SMBG alone. |
Three months |
| To evaluate the correlation of glycemic variability with HbA1c in both groups during the study period. |
Three months |
| To assess the number and nature of treatment modifications (such as changes in insulin dosing, dietary planning, ability to recognize and manage hypoglycemic and hyperglycemic events, and physical activity) prompted by the intermittent scanned CGM group compared to routine SMBG-based decision-making. |
Three months |
| To assess any adverse effects of the use of CGM and its acceptability among children with Type 1 diabetes. |
Three months |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
09/02/2026 |
| 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="1" Months="0" 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
|
This is a randomized controlled, open label, parallel group study designed to compare the change in glycemic variability, measured by the coefficient of variation (CV percent) of glucose levels, at the end of three months between children with type 1 diabetes using intermittent scanned continuous glucose monitoring (isCGM) for fifteen days followed by self monitoring of blood glucose (SMBG), and those using SMBG alone. Secondary objectives include estimating and comparing other glycemic variability metrics such as time in range (IR 70 to 180 mg per dL), time below range (BR less than 70 mg per dL), time above range (AR greater than 180 mg per dL and greater than 250 mg per dL), and the proportion of participants achieving CV less than 36 percent between the two groups. Additional secondary objectives are to compare the change in HbA1c from baseline to three months, evaluate the correlation between glycemic variability and HbA1c, assess treatment modifications including insulin dose adjustments, dietary changes, recognition and management of glycemic excursions, and physical activity prompted by CGM use, and to evaluate any adverse effects and overall acceptability of CGM among children and caregivers. |