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

• Published in: Journal of foot and ankle research Vol. 16; no. 1; pp. 1 - n/a
• Main Authors: Sharma K. N, Srihari, Kumar H, Anil
• Format: Journal Article
• Language: English
• Published: London BioMed Central 28.09.2023; BioMed Central Ltd; Wiley
• Subjects: Accuracy; Amputation; Biothesiometer; Clinical trials; Comparative analysis; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetic foot; Diabetic peripheral neuropathy; Diagnosis; Foot diseases; Leg ulcers; Medical diagnosis; Microvasculature; Nerve conduction; Patients; Peripheral neuropathy; Plantar ulcers; Quantitative sensory testing; Risk factors; Security systems; Skin; Type 2 diabetes; Type 2 diabetes mellitus; Vibration perception threshold; India
• ISSN: 1757-1146; 1757-1146
• DOI: 10.1186/s13047-023-00667-3

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.