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CTRI Number  CTRI/2024/02/063268 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Non-invasive measurement of blood glucose using an optical device 
Scientific Title of Study   Measurement precision, accuracy and user performance evaluation in subjects with and without diabetes, a non-invasive blood glucose measurement device 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angeline Kirubha S P 
Designation  Associate Professor 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Biomedical Engineering, College of Engineering and Technology, SRM Institute of Science and Technology, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9790848570  
Fax    
Email  angelins1@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Preethika A 
Designation  Assistant Professor 
Affiliation  SRM Institute of Science and Technology 
Address  Centre for Clinical Trials and Research (Centre of Excellence), E-Block Extension, 3rd Floor, SRM Medical College Hospital and Research Centre, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8310245190  
Fax    
Email  preethia2@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Sameera Fathimal M 
Designation  Research Scholar 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Biomedical Engineering, College of Engineering and Technology, SRM Institute of Science and Technology, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840709331  
Fax    
Email  sm5282@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology, Kattankulathur 
 
Primary Sponsor  
Name  Angeline Kirubha S P 
Address  Department of Biomedical Engineering, College of Engineering and Technology, SRM Institute of Science and Technology, Kattankulathur - 603203 
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 Preethika A  SRM Medical College Hospital and Research Centre  Centre for clinical Trials and Research, E-Block Extension, 3rd Floor, SRM Medical College Hospital and Research Centre, Kattankulathur
Chennai
TAMIL NADU 		 8310245190

preethia2@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies) - SRM   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants above 21 years  
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Optical Device (Near Infrared -NIR based)  The subject will place his or her finger on a 3D enclosure consisting of the NIR LEDs and detector. The Intervention time will be 1 minute 10 seconds. 
Comparator Agent  Random Blood Glucose and HbA1c  • The 2mL of venous blood sample will also be extracted to perform biochemistry tests (HbA1c and random blood glucose). • The fingerstick glucose testing will be performed by collecting 1µL capillary blood  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Aged 21 years and above
2. Are able to walk to, take public transport to or drive to the testing site independently
3. Able to understand, read and write in English or Tamil.
4. All patients who are diagnosed with diabetes and healthy volunteers.
 
 
ExclusionCriteria 
Details  Pregnant women and patients who are not interested in this research and who are not giving consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The optical device developed will be useful in the non-invasive glucose monitoring.
2. The detector output correlated with the blood glucose, could provide instantaneous blood glucose level at the time of assessment.


 		 Total time frame - 6 months
Calibration of optical device - 4 months
Validation of the optical Device - 2 months

 
 
Secondary Outcome  
Outcome  TimePoints 
Random Blood glucose and HbA1c estimation  Total time frame - 6 months
Calibration of optical device - 4 months
Validation of the optical Device - 2 months



 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/03/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [angelins1@srmist.edu.in].

  6. For how long will this data be available start date provided 22-01-2025 and end date provided 17-10-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Diabetes is the body’s inability to produce insulin. If undiagnosed or untreated it may lead to several health complications. Monitoring an individual’s glucose level is essential to managing it effectively. Present clinical methods are invasive. The optical approach is the most promising technology for non-invasive glucose monitoring. We have developed such an optical system with dual near-infrared wavelengths that have affinity for the glucose molecule. A clinical trial is required to validate the developed device against the gold standard.

At present, invasive blood glucose detection technology is mainstream, convenient, and practical, so both hospitals and household glucometers adopt the method of blood sampling first and then analyzing it in vitro for blood glucose measurement.

 The non-invasive diagnosis of diabetes mellitus can be achieved by the optical system. The optical system consists of dual LEDs and a photodetector in a 3D enclosure. With the measurement site as the index finger, the change in the intensity of the reflected light from the finger is measured. The data is acquired from the patient with the finger placed on the optical system through a personal computer.

The device’s easy-to-use design and painless measurement method are intended to enhance the patient’s quality of life and increase compliance, which will improve diabetes management.

 
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