Introduction and Objective: Bedside clinical methods to screen diabetic peripheral neuropathy (DPN) are not reproducible and detect DPN late. In a recent study of diabetes patients, DPN was detected in 14.4% using the 10 g monofilament (10gMF), increasing to 51.5% with DPN-Check, a point-of-care device measuring sural nerve conduction velocity and amplitude. We evaluated whether DPN-Check-positive subjects have “confirmed” clinical DPN according to gold-standard Toronto Consensus criteria.Methods: 133 participants with type 2 diabetes (mean duration 10±6.7 years; age 55.1±8.4 years; 55% females) with abnormal DPN-Check sural amplitude and/or conduction velocity underwent assessment with the Modified Toronto Clinical Neuropathy Score (mTCNS), conventional nerve conduction studies (sural, peroneal, tibial) and intraepidermal nerve fibre density (IENFD) from ankle skin biopsies. Confirmed DPN was defined as abnormal mTCNS with abnormal nerve conduction studies and/or reduced IENFD. Receiver-operating characteristic (ROC) curves evaluated the diagnostic utility of DPN-Check for confirmed DPN.Results: The AUROC for abnormal DPN-Check amplitude and velocity was 0.74 (95% CI 0.64: 0.83) and 0.75 (0.66: 0.84), respectively. Correlations between DPN-Check sural amplitude and velocity and mTCNS symptom scores were r=0.12 (p=0.3) and r=0.24 (p=0.04); correlations with mTCNS examination scores were r=-0.40 (p<0.001) and r=-0.40 (p<0.001). DPN-Check amplitude and velocity correlated with conventional sural nerve NCS [amplitude r=0.66 (p<0.001); velocity r=0.41 (p=0.01)]. IENFD correlated with DPN-Check amplitude (r=0.45; p<0.001) and velocity (r=0.39; p<0.001).Conclusion: Screen detected subjects with DPN-Check, a quick and objective measure of DPN, have a high probability of having confirmed DPN and an abnormal IENFD, supporting the routine use of this device in clinical practice.
M. Goonoo: None. D. Selvarajah: Speaker’s Bureau; Current; Grünenthal Group. Research Support; Current; Abbott Diabetes, Tandem Diabetes Care, Inc., Dexcom, Inc. T. Fanous: None. K. Low: None. M.A. Abera: None. G. Sloan: None. S. Caunt: None. D.G. Rao: None. P. Karlsson: Consultant; Current; AstraZeneca, Vertex Pharmaceuticals Incorporated. S. Tesfaye: Advisory Panel; Current; AstraZeneca, Nevro Corp. Speaker’s Bureau; Current; Novo Nordisk, Viatris Inc., Medtronic. Advisory Panel; Current; Bayer AG, Wörwag Pharma GmbH & Co. KG. Advisory Panel; Ended; Procter & Gamble, Grünenthal Group.
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