DPNCheck Clinical Evidence

30+ Peer-Reviewed
Studies. One Device.

The accuracy, reliability, and clinical utility of DPNCheck has been established across more than three decades of independent research published in leading medical journals.

30+
Peer-reviewed publications in indexed journals
87%
Sensitivity for detecting diabetic peripheral neuropathy
92%
Specificity vs. traditional nerve conduction studies
95%
Specificity when referenced against healthy controls
Clinical Validation

What the evidence shows.

DPNCheck measures sural nerve conduction velocity and sensory nerve action potential amplitude at the point of care. These are widely accepted biomarkers of peripheral nerve function. The device's validity and reliability against conventional electromyography-lab nerve conduction studies has been confirmed across multiple independent research groups, patient populations, and clinical settings.


Normal reference limits are clearly defined: amplitude above 4 microvolts and conduction velocity above 40 m/s. Results outside these thresholds indicate peripheral neuropathy and can be used to stage severity.

87%

Summary sensitivity for diabetic peripheral neuropathy detection, determined by bivariate meta-analysis across multiple independent validation studies.

*Specificity vs. healthy controls is 95%. Sensitivity and specificity figures are against traditional nerve conduction study as reference standard.

ICC 0.97
Inter-rater reliability for conduction velocity (ICC 2,1)
ICC 0.94
Inter-rater reliability across independent operators
30s
Typical test time per foot, no specialist required
50%
Of diabetic peripheral neuropathies are asymptomatic and missed by standard screening
Publications

Clinical publications.

Independent peer-reviewed research using DPNCheck published across endocrinology, neurology, diabetes care, and primary care journals from 2006 to present.

Showing all publications
2024
Hayashi et al.
Simplified electrophysiological approach combining a point-of-care nerve conduction device and an electrocardiogram produces an accurate diagnosis of diabetic polyneuropathy
Journal of Diabetes Investigation, 2024
Validation
Marion et al. (ADA)
Peripheral Neuropathy: Evaluation of DPNCheck vs. mTCNS in Type 1 Diabetes
American Diabetes Association Scientific Sessions, 2024
Validation
2023
Grabowska et al.
Reliability of a novel point of care device for monitoring diabetic peripheral neuropathy
Scientific Reports, 2023
Reliability
Hoerder S et al.
Acupuncture in diabetic peripheral neuropathy: neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial
World Journal of Diabetes, 2023
RCT
Hu X et al.
Structural changes in Schwann cells and nerve fibres in type 1 diabetes: relationship with diabetic polyneuropathy
Diabetologia, 2023
Outcomes
Lim JZM et al.
Corneal Confocal Microscopy Predicts Cardiovascular and Cerebrovascular Events and Demonstrates Greater Peripheral Neuropathy in Patients with Type 1 Diabetes and Foot Ulcers
Diagnostics (Basel), 2023
Outcomes
2021
Sloan et al.
Pathogenesis, diagnosis and clinical management of diabetic sensorimotor peripheral neuropathy
Nature Reviews Endocrinology, 2021
Review
Carmichael et al.
Advances in Screening, Early Diagnosis and Accurate Staging of Diabetic Neuropathy
Frontiers in Endocrinology, 2021
Review
Vilaca et al.
The Effects of Type 1 Diabetes and Diabetic Peripheral Neuropathy on the Musculoskeletal System: A Case-Control Study
Journal of Bone and Mineral Research, 2021
Outcomes
Abe et al.
Bilirubin is inversely related to diabetic peripheral neuropathy assessed by sural nerve conduction study
Journal of Diabetes Investigation, 2021
Outcomes
Didangelos et al.
Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial
Nutrients, 2021
RCT
2020
Didangelos et al.
Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy
Nutrients, 2020
Trial
Pafili et al.
Clinical Tools for Peripheral Neuropathy to Exclude Cardiovascular Autonomic Neuropathy in Type 2 Diabetes Mellitus
Diabetes Therapy, 2020
Validation
2019
Pafili et al.
Correlation of cardiac autonomic neuropathy with small and large peripheral nerve function in type 2 diabetes mellitus
Diabetes Research and Clinical Practice, 2019
Outcomes
Shibata et al.
Validity and reliability of a point-of-care nerve conduction device in diabetes patients
Journal of Diabetes Investigation, 2019
Validation
Hansen et al.
Efficacy of Long-Term Remote Ischemic Conditioning on Vascular and Neuronal Function in Type 2 Diabetes Patients With Peripheral Arterial Disease
Journal of the American Heart Association, 2019
Trial
Bjornsdottir et al.
A PRPH splice-donor variant associates with reduced sural nerve amplitude and risk of peripheral neuropathy
Nature Communications, 2019
Outcomes
2017
Pafili et al.
NC-stat (DPNCheck) for the Diagnosis of Diabetic Polyneuropathy
Expert Review of Medical Devices, 2017
Validation
Vogt et al.
Assessment of Diabetic Polyneuropathy in Zanzibar: Comparison Between Traditional Methods and an Automated Point-of-Care Nerve Conduction Device
Journal of Clinical and Translational Endocrinology, 2017
Validation
Brown et al.
A Comparison of Screening Tools for the Early Detection of Peripheral Neuropathy in Adults with and without Type 2 Diabetes
Journal of Diabetes Research, 2017
Validation
Kato et al.
Influence of Diabetes and Hemodialysis against Nerve Conduction Studies
Journal of General Practice, 2017
Outcomes
Hamasaki H, Hamasaki Y.
Diabetic Neuropathy Evaluated by a Novel Device: Sural Nerve Conduction is Associated with Glycemic Control and Ankle-Brachial Pressure Index
Journal of Diabetes Investigation, 2017
Outcomes
Darwesh et al.
Isokinetic Testing of Ankle Muscular Strength and Proprioception, Balance and Nerve Conduction in Patients with Polyneuropathy
International Journal of Physiotherapy, 2017
Outcomes
2014 and Earlier
Poulose et al.
Usefulness of the NC-stat DPNCheck Nerve Conduction Test in a Community Pharmacy as an Educational Tool for Patients with Diabetes
Canadian Pharmacists Journal, 2014
Outcomes
Sharma et al.
Assessment of Diabetic Neuropathy Using a Point-of-Care Nerve Conduction Device Shows Significant Associations With the LDIFLARE Method and Clinical Neuropathy Scoring
Journal of Diabetes Science and Technology, 2014
Validation
Lee et al.
Reliability and Validity of a Point-of-Care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy
PLOS ONE, 2014
Validation
Perkins et al.
Validation of a Novel Point-of-Care Nerve Conduction Device for the Detection of Diabetic Sensorimotor Polyneuropathy
Diabetes Care, 2006
Validation
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