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Diabetes Res Clin Pract. 2016 Mar;113:101-7. doi: 10.1016/j.diabres.2015.12.023. Epub 2016 Jan 14.

NerveCheck: An inexpensive quantitative sensory testing device for patients with diabetic neuropathy.

Diabetes research and clinical practice

G Ponirakis, M N Odriozola, S Odriozola, I N Petropoulos, S Azmi, H Fadavi, U Alam, O Asghar, A Marshall, A Miro, A Kheyami, A Al-Ahmar, M B Odriozola, A Odriozola, R A Malik

Affiliations

  1. Weill Cornell Medical College in Qatar, Research Division, Qatar Foundation, Education City, PO. Box 24144, Doha, Qatar; Institute of Human Development, Centre for Endocrinology & Diabetes, Faculty of Medical and Human Sciences, University of Manchester and NIHR/Wellcome Trust Clinical Research Facility, Manchester M13 9NT, UK.
  2. Phi Med Europe Barcelona, Department of Electronics Engineering, Barcelona, Spain.
  3. Institute of Human Development, Centre for Endocrinology & Diabetes, Faculty of Medical and Human Sciences, University of Manchester and NIHR/Wellcome Trust Clinical Research Facility, Manchester M13 9NT, UK.
  4. ICEN, Catalonian Institute of Endocrinology and Nutrition, Medical Centre, Barcelona, Spain; Endocrinology Department, Hospital Clinic Universitario de Barcelona, Spain.
  5. Weill Cornell Medical College in Qatar, Research Division, Qatar Foundation, Education City, PO. Box 24144, Doha, Qatar; Institute of Human Development, Centre for Endocrinology & Diabetes, Faculty of Medical and Human Sciences, University of Manchester and NIHR/Wellcome Trust Clinical Research Facility, Manchester M13 9NT, UK. Electronic address: [email protected]

PMID: 26830855 PMCID: PMC5303576 DOI: 10.1016/j.diabres.2015.12.023

Abstract

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.

Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Keywords: Diabetes; Diagnostic device; NerveCheck; Neuropathy; Quantitative sensory testing

Conflict of interest statement

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

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