DOI: 10.2337/dc08-0500 © 2006 by the American Diabetes Association
Validation of a Novel Point-of-Care Nerve Conduction Device for the Detection of Diabetic Sensorimotor Polyneuropathy
1 University Health Network, Division of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada Address correspondence and reprint requests to Bruce A. Perkins, MD, MPH, Toronto General Hospital, 200 Elizabeth St., Room EN-12-217, Toronto, Ontario, Canada M5G 2C4. E-mail: bruce.perkins{at}uhn.on.ca OBJECTIVEThe diagnosis of diabetic sensorimotor polyneuropathy using objective electrophysiological tests is hindered by limited access to the specialized laboratories and technicians that perform and interpret them. We evaluated the performance characteristics of a novel portable and automated point-of-care nerve conduction study device, which can be operated by nontechnical personnel, and compared it with conventional nerve conduction studies performed in a specialist setting. RESEARCH DESIGN AND METHODSSeventy-two consecutive patients with diabetes (8 type 1, 64 type 2) from a diabetes and a neuropathy outpatient clinic were evaluated concurrently with conventional nerve conduction studies (the reference standard) and the point-of-care device for sural nerve function (sural nerve amplitude potentials in microvolts [µV]). RESULTSSural nerve amplitude potentials measured by the point-of-care device shared very strong correlation with the reference standard (Spearmans correlation coefficient 0.95, P < 0.001). The Bland and Altman method yielded agreement despite a small systematic underestimation by the point-of-care device of 1.2 ± 3.4 µV. Despite this small systematic bias, the sensitivity and specificity of normal and abnormal sural nerve amplitude potentials measured by the point-of-care device for the detection of diabetic sensorimotor polyneuropathy defined by standard clinical and electrophysiological criteria were 92 and 82%, respectively. CONCLUSIONSA novel point-of-care device has excellent diagnostic accuracy for detecting electrophysiological abnormality in the sural nerve of patients who have diabetes. This automated device represents an alternative to conventional nerve conduction studies for the diagnosis of diabetic sensorimotor polyneuropathy.
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