Abstract

The early diagnosis of diabetic peripheral neuropathy (DPN) is challenging. Sudomotor dysfunction is one of the earliest detectable abnormalities in DPN. The present study aimed to determine the diagnostic performance of the electrochemical skin conductance (ESC) test in detecting early DPN, compared with the vibration perception threshold (VPT) test and diabetic neuropathy symptom (DNS) score, using the modified neuropathy disability score (NDS) as the reference standard. Five hundred and twenty-three patients with type 2 diabetes underwent an NDS-based clinical assessment for neuropathy. Participants were classified into the DPN and non-DPN groups based on the NDS (≥ 6). Both groups were evaluated further using the DNS, and VPT and ESC testing. A receiver-operator characteristic (ROC) curve analysis was performed to compare the efficacy of ESC measurements with those of DNS and VPT testing in detecting DPN. The DPN group (n = 110, 21%) had significantly higher HbA1c levels and longer diabetes durations compared with the non-DPN group (n = 413). The sensitivity of feet ESC < 60 μS, VPT testing, and DNS in detecting DPN were 85%, 72%, and 52%, respectively. The specificity of feet ESC, VPT, and DNS in detecting DPN were 85%, 90% and 60% respectively. The areas under the curves of the ROC plots for feet ESC, VPT testing, and DNS were 0.88, 0.84, and 0.6, respectively. A significant inverse linear relationship was noted between VPT and feet ESC (r = -0.45, p = <0.0001). The odds ratios for having DPN, based on the mean feet ESC testing < 60 μS, VPT testing > 15 V, and DNS ≥ 1, were 16.4, 10.9 and 1.8, respectively. ESC measurement is an objective and sensitive technique for the early detection of DPN. Feet ESC measurement was superior to VPT testing for identifying patients with early DPN.

Highlights

  • neuropathy disability score (NDS) was considered a reference standard when evaluating the efficacy of diabetic neuropathy symptom (DNS), vibration perception threshold (VPT) testing, and feet electrochemical skin conductance (ESC) measurements for detecting Diabetic peripheral neuropathy (DPN)

  • Based on the status of the NDS, patients were divided into 2 groups–DPN group (n = 110) and nonDPN group (n = 413) [Table 1]

  • This is the largest study from the Indian sub-continent to evaluate the performance of the ESC test against other well-established methods for the detection of DPN

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Summary

Introduction

Diabetic peripheral neuropathy (DPN) is a frequent complication of type 2 diabetes (T2DM), with a reported prevalence of more than 50% in long-standing cases [1]. Electrochemical skin conductance (ESC) measurement using Sudoscan is an automated and objective tool for the assessment of sweat gland function. It is non-invasive, rapid and easy to perform [12]. The DNS score has not been compared with objective diagnostic techniques such as VPT and ESC testing. The objective of the present study, conducted in a large cohort of Indian patients with T2DM, was to evaluate the sensitivity and specificity of ESC measurements, compared with VPT testing and the DNS, for the detection of early DPN, using a modified neuropathy disability score (NDS) as a reference standard

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