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. 2023 Sep 28;16(1):65.
doi: 10.1186/s13047-023-00667-3.

Assessment of the diagnostic accuracy of Vibrasense compared to a biothesiometer and nerve conduction study for screening diabetic peripheral neuropathy

Srihari Sharma K N  1 , Anil Kumar H  2
Affiliations

Assessment of the diagnostic accuracy of Vibrasense compared to a biothesiometer and nerve conduction study for screening diabetic peripheral neuropathy

Srihari Sharma K N et al. J Foot Ankle Res. .

Abstract

Aims: Peripheral neuropathy is a common microvascular complication in diabetes and a risk factor for the development of diabetic foot ulcers and amputations. Vibrasense (Ayati Devices) is a handheld, battery-operated, rapid screening device for diabetic peripheral neuropathy (DPN) that works by quantifying vibration perception threshold (VPT). In this study, we compared Vibrasense against a biothesiometer and nerve conduction study for screening DPN.

Methods: A total of 562 subjects with type 2 diabetes mellitus underwent neuropathy assessments including clinical examination, 10-g monofilament test, VPT evaluation with Vibrasense and a standard biothesiometer. Those with an average VPT ≥ 15 V with Vibrasense were noted to have DPN. A subset of these patients (N = 61) underwent nerve conduction study (NCS). Diagnostic accuracy of Vibrasense was compared against a standard biothesiometer and abnormal NCS.

Results: Average VPTs measured with Vibrasense had a strong positive correlation with standard biothesiometer values (Spearman's correlation 0.891, P < 0.001). Vibrasense showed sensitivity and specificity of 87.89% and 86.81% compared to biothesiometer, and 82.14% and 78.79% compared to NCS, respectively.

Conclusions: Vibrasense demonstrated good diagnostic accuracy for detecting peripheral neuropathy in type 2 diabetes and can be an effective screening device in routine clinical settings.

Trial registration: Clinical trials registry of India (CTRI/2022/11/047002). Registered 3 November 2022. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=76167 .

Keywords: Biothesiometer; Diabetic peripheral neuropathy; Quantitative sensory testing; Type 2 diabetes mellitus; Vibration perception threshold.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Correlation of Vibrasense average VPTs vs biothesiometer average VPTs
See this image and copyright information in PMC

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