| CTRI Number |
CTRI/2025/08/093514 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of continuous v/s conventional blood glucose monitoring in children with diabetic ketoacidosis- |
|
Scientific Title of Study
|
Comparison of continuous v/s conventional blood glucose monitoring in children with diabetic ketoacidosis-A Open label Randomized control Trial-(COCO Glu Trial) |
| Trial Acronym |
COCO Glu Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COCO Glu Trial |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothi Naik |
| Designation |
Associate Professor Department of paediatrics |
| Affiliation |
Aiims mangalagiri |
| Address |
Aiims Mangalagiri
Department of paediatrics, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
07022530440 |
| Fax |
|
| Email |
naikpuja8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi Naik |
| Designation |
Associate Professor Department of paediatrics |
| Affiliation |
Aiims mangalagiri |
| Address |
Aiims Mangalagiri
Department of paediatrics, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
07022530440 |
| Fax |
|
| Email |
naikpuja8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyothi Naik |
| Designation |
Associate Professor Department of paediatrics |
| Affiliation |
Aiims mangalagiri |
| Address |
Aiims Mangalagiri
Department of paediatrics, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
07022530440 |
| Fax |
|
| Email |
naikpuja8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR JYOTHI NAIK |
| Address |
Aiims mangalagiri |
| 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 Jyothi Naik |
All india institute of medical sciences |
AIIMS MANGALAGIRI, Guntur, Andhra Pradesh
Department of paediatrics room 3rd floor opd block room number 326
Guntur
ANDHRA PRADESH |
07022530440
naikpuja8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee aiims mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous glucose monitoring |
continuous glucose monitoring in children with diabetic ketoacidosis aged 5 to 14 years using CGM machine |
| Comparator Agent |
Conventional blood glucose monitoring |
standard method of capillary blood glucose testing using glucometer in children with diabetic ketoacidosis aged 5 to 14 years |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All children in age group 5-14 years with moderate to severe DKA admitted to PICU |
|
| ExclusionCriteria |
| Details |
1. known comorbid diseases(cardiac,,CKD,neurological disease)
2.Presence of haemodynamic instability or multi organ failure
3.known allery or contraindication to GCM sensor
4.subjects who have not given consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accuracy of glucose monitoring
Agreement between CGM values and standard lab venous values |
Time in range during DKA management0-6 hours after starting insulin 6-12 hours 12 hours to biochemical resolution target range of 150-200mg/dl |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
detection of hypoglycemia & hyperglycemia
number of blood glucose measurements required
time of resolution of dka
length of hospital stay
|
time in range during management
0 to6 hoursafter starting insulin
6 to 12 hours
12 hours biochemical resolution of diabetic ketoacidosis
first 24 hours after resolusion
|
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
01/10/2025 |
| 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 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
|
We aim to compare continuous verses conventional blood glucose monitoring in children with diabetetic ketoacidosis an open label randomized trial .There are few studies examining the use of CGM inchildren with DKA in this part of the country . We are evaluating feasibility and acceptabilityof CGM device in paediatric population with DKA While CGM shows promise for enhancingglucose monitoring during paediatric DKA it has not been validated. By futher research we would like to explore avenues in its accuracy,feasibility ,reliability and safety inthis critical setting compared to POCT glucose monitoring methods |