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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.

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. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098640
Enrollment
281
Registered
2025-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Nil: Nil

Sponsors

Saveetha Medical college and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed cases of diabetes. 2. Individuals who provide informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: one time assessment

Secondary

MeasureTime frame
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.Timepoint: one time assessment

Countries

India

Contacts

Public ContactDr Joseline Sofia Sharon

Saveetha Medical College And Hospital, Chennai

joselinesofia994@gmail.com6379465181

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026