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.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Saveetha Medical college and Hospital
- Enrollment
- 281
- Locations
- 1
- Primary Endpoint
- 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.
Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases of diabetes.
- •Individuals who provide informed consent to participate in the study.
Exclusion Criteria
- •1.Individuals with type 1 diabetes.
- •Individuals with peripheral arterial disease.
- •Pregnant women and Individuals with other pre-existing conditions affecting peripheral nerves.
- •Individuals on any medication that may adversely influence peripheral nerve function
- •Participants who are unable or unwilling to provide informed consent.
Outcomes
Primary Outcomes
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.
Time Frame: one time assessment
The expected outcome of the study is to validate the newly developed device to detect
Time Frame: one time assessment
diabetic neuropathy and enable early detection even in its initial stage, improving access to affordable
Time Frame: one time assessment
Secondary Outcomes
- 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 &)
Investigators
Dr Joseline Sofia Sharon
Saveetha Medical College and Hospital, Chennai.