| CTRI Number |
CTRI/2025/03/083238 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Free style Libre for diabetes 2 management |
|
Scientific Title of Study
|
Glucose monitoring by Freestyle Libre in patients with Type 2 diabetes mellitus from India A pooled analysis |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ADC-01 Version: 01 Date: 24-10-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Bhandari |
| Designation |
Head of Publications |
| Affiliation |
Indegene Private Limited |
| Address |
Indegene Limited
(formerly known as
Indegene Private Limited)
Aspen Block G4, 3rd Floor
Manyata Embassy Business Park
Outer Ring Road, Nagawara
Bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8886484343 |
| Fax |
|
| Email |
rohit.bhandari@indegene.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roopa Subbaiah |
| Designation |
Associate Manager Scientific Writing |
| Affiliation |
Indegene Private Limited |
| Address |
Indegene Limited
(formerly known as
Indegene Private Limited)
Aspen Block G4, 3rd Floor
Manyata Embassy Business Park
Outer Ring Road, Nagawara
Bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8884759000 |
| Fax |
|
| Email |
roopa.subbaiah@indegene.com |
|
Details of Contact Person
Public Query
|
| Name |
Roopa Subbaiah |
| Designation |
Associate Manager Scientific Writing |
| Affiliation |
Indegene Private Limited |
| Address |
Indegene Limited
(formerly known as
Indegene Private Limited)
Aspen Block G4, 3rd Floor
Manyata Embassy Business Park
Outer Ring Road, Nagawara
Bengaluru - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8884759000 |
| Fax |
|
| Email |
roopa.subbaiah@indegene.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt.Ltd.
Floor 16, Godrej BKC,
Plot C- 68, G block, Bandra Kurla Complex, Near MCA Club, Bandra (E)
Mumbai- 400051 |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt.Ltd. |
| Address |
Floor 16, Godrej BKC,
Plot C- 68, G block, Bandra Kurla Complex, Near MCA Club, Bandra (E)
Mumbai- 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mudit Sabharwal |
Dharma Diabetes & Metabolic Clinics |
Department/Division- Diabetes and Endocrinology,
Room no.- 2,
Metro Station Greater Kailash, B-6, Greater Kailash Enclave II, Greater Kailash, New Delhi, Delhi 110048
New Delhi
DELHI |
9811255505
drmuditsabharwal@gmail.com |
| Dr Praveen Ramachandra |
DiaPlus Clinic |
Department/Division: Endocrinology,
Room no.- 4,
Yelahanka New Town, @ Arka Hospitls, Bengaluru, Karnataka 560064
Bangalore
KARNATAKA |
7795323949
praveenendocrine@gmail.com |
| Dr Sonali Patange |
Dr. Sonali Patangi’s Speciality Diabetic Centre |
Department/Division: Diabetology,
Room no.- 304, Flat no 304 , Nirmal sagar chs, L.J Road Shivaji park diagonally, opp. Shiv Sena Bhavan, Dadar West, Mumbai, Maharashtra 400028
Mumbai
MAHARASHTRA |
9820397876
meetdocsp@yahoo.com |
| Dr Anish Ahammed |
Endodiab Speciality Center |
Department of Endocrinology,
Division: Diabetology,
Room no.- 3, 3rd Sheikh Square, Mavoor Rd, Parayancheri, Kozhikode, Kerala 673016
Kozhikode
KERALA |
09447404212
anish004@hotmail.com |
| Dr Vipul Gupta |
Gupta Ultrasound & Heart Care Centre, |
Department of Medicine,
Division: Diabetology,
Room no.- 401/407,
A-4/22, A 4 Block, Paschim Vihar, New Delhi, Delhi, 110063
New Delhi
DELHI |
9811072661
guptasvipul@hotmail.com |
| Dr Rajiv Kovil |
Kovil Diabetes Care Centre |
Department/Division: Diabetology,
Room no.- 2,Lokhandwala Complex-Andheri West, Mumbai
Mumbai
MAHARASHTRA |
9820127777
drrajivkovil@hotmail.com |
| Dr Shalini Jaggi |
LIFECARE DIABETES CENTRE |
Department of Diabetology,
Division: Diabetes & NCDs,
First Floor,
Room no.- 01-02, A26 FIRST FLOOR TAGORE MARKET, Kirti Nagar, New Delhi, Delhi 11001
New Delhi
DELHI |
9871064269
dr.shalini.bj@gmail.com |
| Dr Manoj Chawla |
Lina Diabetes Care Centre |
Room no.- 4, Department/Division: Diabetology
704, Cosmos Plaza, Opp. Indian Oil Nagar, J P Road, Near D N Nagar Metro station, Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA |
9820002333
drmanojchawla@yahoo.com |
| Dr Ajay Kumar Gupta |
MadhuMeha Clini |
Department of Internal Medicine,
Division: Consultancy,
Room no.- 29/D, Mayur Vihar Phase 2,
Delhi 110091
New Delhi
DELHI |
9871134389
drajaykumargupta@gmail.com |
| Dr Pankaj Aneja |
Naveda Healthcare center |
Department of Diabetes and Metabolic Disorders,
Division: Diabetology,
Room no.- 3,
57 & 61, Pocket D-15, opp. Metro Pillar No 418, adjacent to Geetaratan Jindal Public School, Sector 7, Rohini, New Delhi, Delhi 110085
New Delhi
DELHI |
9811117266
drpankajaneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Indira IVF Hospital Ethics Committee - Mumbai |
Approved |
| Indira IVF Hospital Ethics Committee - Mumbai |
Approved |
| Indira IVF Hospital Ethics Committee - Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention name: FreeStyle Libre
|
The FreeStyle Libre system is a professional flash glucose monitoring system approved in
India. This system can monitor blood glucose for 14 consecutive days of wear per sensor. The
systematic analysis of the CGM data stored in the CGM systems not only allows visualization
of glucose changes over time, but also helps to identify the factors that cause such changes and
provides clues for optimizing diabetes therapy in CGM patients from India.
The total duration of intervention is 4 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years with a diagnosis of T2D using Libre for glucose
monitoring will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients below 18 years as well as patients using continuous glucose
monitoring instrument other than Libre will be excluded. Patients having difficulty in handling
device and are non-compliant will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimate the average TIR across 12-15 centres in patients with Diabetes in India with the help of cross sectional data available |
Baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Estimate % of patients with diabetes in India achieving recommended TIR targets (in line with customized targets based on comorbidities/ type of diabetes)
•Estimate average TIR among different patient profiles with T2DM based on 1) comorbidities 2) Age groups 3) Form of pharmacotherapy (Non Insulin, Basal Insulin, MDI) 4) Duration of diabetes
•Estimating % of patients with T2DM achieving TIR targets based on 1) comorbidities 2) Age groups 3) Form of pharmacotherapy (Non Insulin, Basal Insulin, MDI) 4) duration of diabetes |
Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
24/03/2025 |
| 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="0"
Months="0"
Days="14" |
|
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
|
This study aims to evaluate the average Time in Range (TIR) in Type 2 Diabetes Mellitus (T2DM) patients using the FreeStyle Libre system across 12 centres in India. The secondary objectives include assessing the percentage of patients achieving recommended TIR targets and exploring variations in TIR based on factors such as age, gender, BMI, medication type, and comorbidities. Data from approximately 1500 patients will be analyzed, focusing on key metrics like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and glucose variability. Statistical analysis will include Spearman’s coefficient and linear regression to determine relationships between various patient characteristics and glycaemic control. |