ProCVT Smart-Sheet

The global prevalence of diabetes is increasing at an alarming rate – and with it, cardiac autonomic neuropathy (CAN). CAN is a severe and possibly fatal manifestation of dysfunction of the autonomic nervous system (dysautonomia). It’s the most severe diabetic complication, contributing to arrhythmias, myocardial infarctions and sudden death – hence its nickname, ‘the silent killer’. This incurable condition also affects patients with other disorders, such as multiple sclerosis and Parkinson’s disease. Early recognition is crucial to preventing or slowing its progression.

The Inspiration Behind the Innovation

The clinical manifestation of CAN is pleomorphic, appearing only in the late stages of diabetes when nerve damage is irreversible. Current clinical guidelines for annual checkups do not include specific diagnostic tests – and clinicians working with diabetic patients often request a tool that's capable of detecting CAN and quantifying the severity of dysautonomia.

The current gold-standard diagnostic method is the cardiac autonomic reflex test, which is time-consuming and only gives a ‘positive’ result when the denervation of the controlling nerves is permanent, leaving limited treatment options. The other option is the analysis of long-term heart rate variability (HRV) obtained with a Holter ECG monitor, which is influenced by external factors such as stress and inconsistent electrode adherence that can interfere with data quality, and complicate interpretation.

The Innovation 

The ProCVT Smart-Sheet is a wireless ECG monitor that samples with a rate of 1 kHz and 24-bit resolution. It's intended for nocturnal sleep recordings, which reduces the influence of external factors. The wifi-enabled device consists of a sensor sheet with six capacitive ECG electrodes and three temperature sensors connected to a control box. It automatically transfers metadata to a cloud-based system that uses state-of-the-art algorithms to calculate cardiac vagal tone (CVT). CVT is a proxy for the efferent parasympathetic function mediated through the vagal nerve, meaning it can be used to instantly assess autonomic function without further processing.

The device's creators believe that it could represent an important first step towards home monitoring of the autonomic nervous system, leading to more timely detection of CAN.  

The Team

Maria Bitsch Poulsen: MSc, PhD-fellow; Aalborg University Hospital & Aalborg University

Christina Brock: DVM, PhD, Professor; Aalborg University