| CTRI Number |
CTRI/2025/12/098640 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to test the accuracy of a new device for detecting peripheral nerve damage in people with type 2 diabetes in a community near Thiruvallur. |
|
Scientific Title of Study
|
Diagnostic accuracy of newly developed multicomponent peripheral Diabetic Neuropathy screening device among type 2 diabetes in the field practice
area of a tertiary care hospital in Thiruvallur- A randomized control trial. |
| 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 Joseline Sofia Sharon |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital, Chennai. |
| Address |
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
6379465181 |
| Fax |
044 6672 6611 |
| Email |
joselinesofia994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseline Sofia Sharon |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College And Hospital, Chennai |
| Address |
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
6379465181 |
| Fax |
044 6672 6611 |
| Email |
joselinesofia994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joseline Sofia Sharon |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital, Chennai. |
| Address |
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
6379465181 |
| Fax |
044 6672 6611 |
| Email |
joselinesofia994@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Medical college and Hospital |
| Address |
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105 |
| Type of Sponsor |
Private medical college |
|
|
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 Joseline Sofia Sharon |
Saveetha Medical college and Hospital |
Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Chennai
TAMIL NADU |
6379465181
joselinesofia994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of diabetes.
2. Individuals who provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Individuals with type 1 diabetes.
2. Individuals with peripheral arterial disease.
3. Pregnant women and Individuals with other pre-existing conditions affecting peripheral
nerves.
4. Individuals on any medication that may adversely influence peripheral nerve function
5. Participants who are unable or unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome of the study is to validate the newly developed device to detect
diabetic neuropathy and enable early detection even in its initial stage, improving access to affordable
and convenient screening particularly in underserved or resource limited areas. It is expected to prove a user friendly, practical and feasible point of care use in community and field settings providing alternate to traditional diagnosis. |
one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study seeks to contribute to the development of scalable screening programs &
healthcare policies targeting the low resource setting to reduce the burden on healthcare system &
improve community health. |
one time assessment |
|
|
Target Sample Size
|
Total Sample Size="281"
Sample Size from India="281"
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)
|
01/01/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 research study to validate a newly developed portable non invasive
multicomponent peripheral diabetic neuropathy point of care screening device among prediabetic and
type 2 diabetes in the field practice area of a tertiary care hospital in Kanchipuram. The study participants will be the individuals residing in the field
practice area of the tertiary care hospital in Kanchipuram with prediabetic and type 2 diabetes.
individuals will be selected based on their inclusion criteria and after getting informed consent they
will be enrolled in the study. The participant can also be excluded from the study based on the
exclusion criteria. The information provided by the participant will be documented by
the investigators in a proforma. This information will be recorded and compared with the results from
other participating patients. No names will ever be used and data will be kept confidential.
Furthermore, you may not receive any compensation, royalty, or other financial benefit that may
result from any procedure. There will be minimum or no risk to the participants while
investigating into the study research. |