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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  
Name  Address 
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 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  
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  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.

 
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