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Background: Accurate and economic detection of nerve damage in diabetes is key to more widespread diagnosis of patients with diabetic peripheral neuropathy (DPN) and painful diabetic neuropathy. This study examined the diagnostic performance of NerveCheck, an inexpensive ($500) quantitative sensory testing (QST) device., Methods: One hundred forty-four subjects (74 with and 70 without diabetes) underwent assessment with NerveCheck, neuropathy disability score (NDS), nerve conduction studies (NCS), intraepidermal and corneal nerve fiber density (IENFD and CNFD), and McGill questionnaire for neuropathic pain., Results: Of the 74 subjects with diabetes, 41 were diagnosed with DPN based on the NDS. The NerveCheck scores for vibration perception threshold (VPT), cold perception threshold (CPT), and warm perception threshold (WPT) were significantly lower (P ≤ 0.0001) in diabetic patients with DPN compared to patients without DPN. The diagnostic accuracy of VPT was high with reference to NCS (area under the curve [AUC]: 82%-84%) and moderate for IENFD, CNFD, and neuropathic pain (AUC: 60%-76%). The diagnostic accuracy of CPT and WPT was moderate with reference to NCS, IENFD, and CNFD (AUC: 69%-78%) and low for neuropathic pain (AUC: 63%-65%)., Conclusions: NerveCheck is a low-cost QST device with good diagnostic utility for identifying sensory deficits, comparable to established tests of large and small fiber neuropathy and for the severity of neuropathic pain., Competing Interests: Author Disclosure Statement G.P. researched data and wrote the article. A.O., M.N.O., S.O., A.M., and M.B.O. designed and created the NerveCheck. I.N.P., S.A., M.F., H.F., U.A., A.M., A.K., M.T., A.A.-A., and M.J. researched data. R.A.M. reviewed and edited the article and is the guarantor of this work. Phi Med Europe S.L. provided the NerveCheck device and funded half of the study. M.N.O., S.O., M.B.O., and A.O. are the owners and inventors of the NerveCheck. The authors confirm that the article has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship and are not listed. They further confirm that the order of authors listed in the article has been approved by all of them.

Aims: Sensory neuropathy is central to the development of painful neuropathy, and foot ulceration in patients with diabetes. Currently, available QST devices take considerable time to perform and are expensive. NerveCheck is the first inexpensive ($500), portable QST device to perform both vibration and thermal testing and hence evaluate diabetic peripheral neuropathy (DPN). This study was undertaken to establish the reproducibility and diagnostic validity of NerveCheck for detecting neuropathy., Methods: 130 subjects (28 with DPN, 46 without DPN and 56 control subjects) underwent QST assessment with NerveCheck; vibration perception and thermal testing. DPN was defined according to the Toronto criteria., Results: NerveCheck's intra correlation coefficient for vibration, cold and warm sensation testing was 0.79 (95% LOA: -4.20 to 6.60), 0.86 (95% LOA: -1.38 to 2.72) and 0.71 (95% LOA: -2.36 to 3.83), respectively. The diagnostic accuracy (AUC) for vibration, cold and warm sensation testing was 86% (SE: 0.038, 95% CI 0.79-0.94), 79% (SE: 0.058, 95% CI 0.68-0.91) and 72% (SE: 0.058, 95% CI 0.60-0.83), respectively., Conclusions: This study shows that NerveCheck has good reproducibility and comparable diagnostic accuracy to established QST equipment for the diagnosis of DPN., Competing Interests: We wish to draw the attention of the Editor to the following facts which may be considered as potential conflicts of interest and to financial contributions to this work. Phi Med Europe S.L. provided the Nervecheck device, funded half of the study and covered some of the travel expenses and conference registration fees for presenting the results of this study. M.N. Odriozola, S. Odriozola, M.B. Odriozola and A. Odriozola are the owners and inventors of the NerveCheck. We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us., (Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)