| CTRI Number |
CTRI/2025/10/096037 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Accuracy of LINX Continuous Glucose Monitor |
|
Scientific Title of Study
|
A Prospective Open-Label Trial Comparing the Accuracy and Reliability of LINX Continuous Glucose Monitor (CGM) |
| Trial Acronym |
OPEN-LINX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chhavi Mehra |
| Designation |
Medical Director |
| Affiliation |
Ragus Healthcare Pvt Ltd |
| Address |
Department of Endocrinology
Ragus healthcare Pvt Ltd
17 and 17C BDA 18th cross road Sector 3
HSR Layout
Bengaluru Urban
Department of Endocrinology
Ragus healthcare Pvt Ltd
17 and 17C BDA 18th cross road Sector 3
HSR Layout
Bengaluru Urban
Bangalore
KARNATAKA
560102
India |
| Phone |
7483703145 |
| Fax |
|
| Email |
chhavi.mehra@sugarfit.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Annie R |
| Designation |
Lead Researcher |
| Affiliation |
Ragus Healthcare Pvt Ltd |
| Address |
Department of Research and Development
17 and 17C BDA Sector 3 HSR layout Bengaluru Bengaluru Urban Karnataka 560102
Department of Research and Development
17 and 17C BDA Sector 3 HSR layout Bengaluru Bengaluru Urban Karnataka 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
9742744560 |
| Fax |
|
| Email |
annie.mattilda@sugarfit.com |
|
Details of Contact Person
Public Query
|
| Name |
Annie R |
| Designation |
Lead Researcher |
| Affiliation |
Ragus Healthcare Pvt Ltd |
| Address |
Department of Research and development
17 and 17C BDA Sector 3
HSR layout
Bengaluru Urban Karnataka 560102
Department of Research and development
17 and 17C BDA Sector 3
HSR layout
Bengaluru Urban Karnataka 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
9742744560 |
| Fax |
|
| Email |
annie.mattilda@sugarfit.com |
|
|
Source of Monetary or Material Support
|
| POS Enterprises for Investment and Management LLC, 1905 The Exchange Tower, Business Bay, Dubai-50001. |
|
|
Primary Sponsor
|
| Name |
Khaled Salah |
| Address |
1905 The Exchange Tower Business Bay Dubai 50001 |
| Type of Sponsor |
Other [HEALTHCARE INDUSTRY] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| CHHAVI MEHRA |
RAGUS HEALTHCARE PVT LTD |
Department of endocrinology
Ragus healthcare Tvt Ltd
17 and 17C BDA Sector 3 HSR layout Bengaluru Bengaluru Urban Karnataka 560102
Bangalore
KARNATAKA |
9742744560
chhavi.mehra@sugarfit.com |
| SHALINI C |
RAGUS SITE 2 |
Department of endocrinology
Rudrappa Hospital
5 Rajaram Mohan Roy cross road Richmond circle
Bangalore 560025
Bangalore
KARNATAKA |
7411822126
c.shalini@sugarfit.com |
| AKSHAYA NAGRAJ |
RAGUS SITE 3 |
Department of Endocrinology
324 19th Cross
6th Block Jayanagar
Bangalore 560070
Bangalore
KARNATAKA |
9986740352
akshaya.nagaraj@sugarfit.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Without Diabetes Mellitus |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abbott freestyle Libre CGM |
Single transcutaneous sensor applied to the right upper arm. Continuous interstitial glucose monitoring. Scanned read per IFU. Worn continuously for 14 to 15 days. |
| Comparator Agent |
Glucometer |
Multiple checks at different time intervals in the span of 14 to 15 days of continuous glucose monitoring were done to assess the accuracy of 3 different CGM systems |
| Comparator Agent |
iCAN CGM |
Single transcutaneous sensor applied to the abdomen. Continuous interstitial glucose monitoring paired with app or receiver per ifu. Worn continuously for 14 to 15 days. |
| Intervention |
Linx continuous glucose monitor device |
Single transcutaneous sensor applied to the left upper arm. Continuous interstitial glucose monitoring paired with companion app or reader as per manufacturers instructions. Worn continuously for 14 to 15 days |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to wear all three CGM sensors (Linx, Abbott, and i-Can) simultaneously for 14-15 days. 2. Willing to perform structured capillary blood glucose testing as per protocol. 3. Capable of understanding the study requirements and providing written informed consent. 4. No participation in any other clinical study within the past 30 days.
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed with type 1 diabetes or a recent episode of diabetic ketoacidosis (within the past 3 months). 2. Pregnant or lactating individuals. 3. Presence of chronic skin conditions or dermatological issues that may interfere with sensor placement. 4. Severe comorbidities or conditions that may impair study compliance (e.g. Cognitive impairment, psychiatric illness). 5. End-stage renal disease or significant renal impairment (e-GFR less than 30 ml/min/1.73 meter square). 6. Use of medications or medical devices that may interfere with CGM function or study outcomes, including substances affecting CGM performance (e.g. Hydroxyurea, acetaminophen, high dose Vitamin C), anticoagulants (except acetylsalicylic acid less than or equal to 100 mg), cardiac pacemakers or similar medical devices. 7. Planned medical procedures during the study that may impact CGM performance (e.g. MRI, CT scan, radio frequency ablation, high frequency electrical heat or high intensity focused ultrasound). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy-Mean absolute relative difference (MARD), error grid analysis, correlation metrics, glycemic range metrics. |
baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| User experience & satisfaction, sensor usability, sensor data reliability, adherence to SMBG protocol, safety & tolerability. |
Baseline & after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2025 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 prospective, open-label, multicentric, parallel-use interventional trial will evaluate the accuracy, reliability, and user experience of three CGM systems-LINX (MicroTech Medical), Abbott FreeStyle Libre, and iCAN (Sinocare Inc.) against capillary blood glucose (CBG) as the reference standard. A total of 150 adults (75 with T2DM and 75 without diabetes) will be enrolled across three clinical sites in Bangalore, India, where all participants will simultaneously wear the three CGMs for 14 to 15 days (LINX on the left arm, Abbott on the right arm, and iCAN on the abdomen), with greater than or equal to 32 paired CBG readings collected. Primary endpoints include mean absolute relative difference (MARD) (less than 15 percent), error grid analysis (greater than 95 percent values in Zones A and B), correlation with CBG, and glycemic range metrics (time in range (TIR), time above range (TAR), time below range (TBR), in percentage). Secondary endpoints assess usability, satisfaction, adherence to SMBG, data reliability, and safety (skin or device-related events). |