College of Physiotherapy, Dayananda Sagar University, Shavige Malleshwara Hills, 1st Stage, Kumaraswamy Layout, Bangalore, Karnataka, India, 560111.
Department of Medicine, Dr Chandramma Dayananda Sagar Institute of Medical Education and Research (CDSIMER), Kanakapura, Karnataka, India.
J Foot Ankle Res. 2023 Sep 28;16(1):65. doi: 10.1186/s13047-023-00667-3.
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.
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.
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.
Vibrasense demonstrated good diagnostic accuracy for detecting peripheral neuropathy in type 2 diabetes and can be an effective screening device in routine clinical settings.
Clinical trials registry of India (CTRI/2022/11/047002). Registered 3 November 2022. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=76167 .
周围神经病变是糖尿病常见的微血管并发症，也是糖尿病足溃疡和截肢的危险因素。Vibrasense（Ayati Devices）是一种手持式、电池供电的快速糖尿病周围神经病变（DPN）筛查设备，通过量化振动感觉阈值（VPT）来工作。在这项研究中，我们比较了 Vibrasense 与生物感觉计和神经传导研究在 DPN 筛查中的表现。
共有 562 名 2 型糖尿病患者接受了神经病学评估，包括临床检查、10 克单丝测试、VPT 评估（使用 Vibrasense 和标准生物感觉计）。Vibrasense 平均 VPT≥15V 的患者被认为患有 DPN。这些患者中有一部分（N=61）接受了神经传导研究（NCS）。Vibrasense 的诊断准确性与标准生物感觉计和异常 NCS 进行了比较。
Vibrasense 测量的平均 VPT 与标准生物感觉计值呈强正相关（Spearman 相关系数 0.891，P<0.001）。与生物感觉计相比，Vibrasense 的敏感性和特异性分别为 87.89%和 86.81%，与 NCS 相比分别为 82.14%和 78.79%。
Vibrasense 对 2 型糖尿病患者周围神经病变的检测具有良好的诊断准确性，可作为常规临床环境中的有效筛查设备。
印度临床试验注册中心（CTRI/2022/11/047002）。于 2022 年 11 月 3 日注册。https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=76167。
