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

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 .