High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-07-31

Brief Summary

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Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

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Detailed Description

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Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Conditions

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Diabetic Autonomic Neuropathy Diabetic Neuropathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group

patients with diabetes mellitus

Neuropad

Intervention Type DIAGNOSTIC_TEST

Neuropad examination was performed in all patients, after 10 minutes of rest without socks in a well-temperatured room. The result was considered normal if there was a complete color change and abnormal if there was no or incomplete color change.

Interventions

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Neuropad

Neuropad examination was performed in all patients, after 10 minutes of rest without socks in a well-temperatured room. The result was considered normal if there was a complete color change and abnormal if there was no or incomplete color change.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* diabetes mellitus

Exclusion Criteria

* age\>75 years,
* estimated creatinine clearance rate (using the Cockcroft-Gault formula) \<30 ml/ min,
* history of limp amputation,
* causes of neuropathy other than diabetes,
* drugs that can affect perspiration, and
* skin disorders that could affect the result.

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No