NerveCheck Master, a new screening tool for cardiac autonomic neuropathy?

Aims: This study aimed to evaluate the accuracy of NerveCheck Master (NCKM) against Michigan Neuropathy Screening Instrument (MNSI) examination to detect cardiac autonomic neuropathy (CAN) in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM).  NCKM is a portable device designed to assess vibration, warm, cold and heat pain perception thresholds. Given the need for accessible and efficient tools for early diabetic neuropathy detection, the study explores whether NCKM can serve as a reliable point-of-care diagnostic device.

Methods: This bi-centre observational study enrolled 76 patients with T1DM (median age of 35 years and duration of 13.5 years) and 65 with T2DM (median age of 59 years and duration of 10 years) attending the Jean Verdier Hospital (Bondy, France) or the Policlinico of Naples (Italy). Inclusion criteria were age >18 years, T1D and T2D diagnosis, and ability to complete diagnostic procedures. Exclusion criteria included pregnancy, neuropathies of any other aetiology and history of stroke. Each patient underwent MNSI examination (including foot inspection for deformities and ulcers, 10 g monofilament, vibration sensitivity at great toe, and ankle reflex, diagnostic cut-off for diabetic polyneuropathy [DPN] ≥2.5), NCKM testing for vibration (VPT), warm (WPT), cold (CPT) and heat pain (HPT) perception thresholds (diagnosticdefinition for DPN ≥2 abnormal thresholds), and CAN by 4 cardiovascular tests (diagnostic definition for CAN ≥2 abnormal tests).

Results: According to MNSI the prevalence of DPN was 26.3% in T1DM and 35.4% in T2DM. According to NCKM tests, the DPN prevalence was 61.8 % and 70.8 %, respectively. The prevalence of CAN was 22.4% and 41.4% among patients with T1DM and T2DM, respectively. Considering DPN as defined by NCKM, the association with CAN was significant in the whole population (p=0.013) and in T1D, not in T2D. Among T1DM patients the prevalence of CAN was markedly higher in those with DPN than in those without (31.9% vs 6.9%, p=0.011). A ROC curve analysis was performed to evaluate the performance of the total NCKM score (defined upon the 4 tests) for the detection of patients with CAN. The ROC-AUC was 0.62 for the total population, 0.67 for T1DM patients and 0.55 for T2DM subjects. An NCKM score of 2 abnormal tests was identified as the best cut-off level, which offered rather good sensitivity and negative predictive value, particularly among patients with T1DM (88.2% and 93.1%, respectively), while the performance was lesser in patients with T2DM (75% and 66.7%, respectively).

Conclusions: NCKM positivity identifies a higher likelihood of CAN and is an attractive approach to detect patients to screen for CAN.

Comments: This multicentre study compared, for the first time, NCKM testing with MNSI, in patients with diabetes. The main results were that NCKM detects far more patients with DPN than the physical component of MNSI and that DPN as diagnosed using NCKM is associated with co-existing CAN, in particular in T1DM. This data supports that the presence of damage of small fibres at lower limbs, detected using NCKM, is associated with a cardiovascular autonomic dysfunction. The Authors proposed the potential role of NCKM, an easy and very quick tool, in a screening step to identify patients with diabetes who should be further assessed for CAN. Larger studies will be useful to test this tool as a concrete screening approach capable of reducing the number of patients tested for CAN and therefore improving the diagnosis of CAN. 

Fabiana Picconi

Reference: Galiero R, Rezki A, Simeon V, Beccia D, Alfano M, Caturano A, Sasso FC, Valensi P. NerveCheck master to screen patients with type 1 or type 2 diabetes for peripheral and cardiac autonomic neuropathy. J Diabetes Complications. 2025 Sep;39(9):109107. doi: 10.1016/j.jdiacomp.2025.109107. Epub 2025 Jun 7. PMID: 40505203.

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