| CTRI Number |
CTRI/2024/07/071227 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Glucose monitoring by wearable watch |
|
Scientific Title of Study
|
Feasibility for the use of a non-invasive wearable device for glucose monitoring. |
| 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 V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology, Room No.:1
No.4, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968888 |
| Fax |
04428359038 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology, Room No.:1
No.4, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968888 |
| Fax |
04428359038 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist and HOD Clinical Trials |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4,Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luminosity
Luminosity Wearables
3401 Grays Ferry Avenue
Building 450, Suite 1088
|
|
|
Primary Sponsor
|
| Name |
Luminosity |
| Address |
3401 Grays Ferry Avenue
Building 450, Suite 1088 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 S Poongothai |
Madras Diabetes Research Foundation |
Department Of Clinical Trials
No.4, Conran Smith Road,
Gopalapuram
Chennai
TAMIL NADU |
9840134505
poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LUMOS wearable device |
A fingertip version of the LUMOS device uses non-invasive optical spectroscopy to determine physiological responses of the fingertip. The device will noninvasively collect spectroscopy data using optical sensors that emit light in the visible spectrum. The raw data is stored on the device and encrypted. Duration Of Intervention is 2 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of 18 years or older.
2. Ability to provide informed consent.
3. Reports having a secure place to store an
electronic device.
|
|
| ExclusionCriteria |
| Details |
1. Inability to consent.
2. Presence of hand tattoos or markings that could
interfere with the optical sensor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining whether it is feasible |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining whether it is acceptable. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
04/09/2024 |
| 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 - NO
|
|
Brief Summary
|
The study is designed to collect and evaluate the LUMOS biosensor data on subjects with varying blood sugar levels during fasting and post-prandial sessions. The LUMOS device’s optical data collected from the finger non-invasively. LUMOS is a non-invasive wearable spectroscopy device (25) with form factors that can be used for on-body sensing. The device could accurately detect wavelengths or a combination of wavelengths within 13 nm with similar ratios of intensity to the ground truth spectrometer. A fingertip version of the LUMOS device uses non-invasive optical spectroscopy to determine physiological responses of the fingertip. Each device is powered by a lithium-ion battery that will last up to 10 days based on lab experiments. Data on the LUMOS Device is stored on the device which is encrypted to be FIPS (Federal Information Processing Standard) 140-24 compliant using AES encryption. After the exit visit, physiological data will be downloaded off the device onto a password-protected and encrypted study computer via a USB connection. Then, it will be uploaded onto a HIPAA-compliant an encrypted web-platform. |