Understanding our ESC Technology for Detecting and Monitoring DPN

Electrochemical Skin Conductance (ESC) is a physiological parameter that measures the reactivity of sweat glands and small nerve fibers in the skin to electrical stimuli. Elevated blood sugar levels can harm blood vessels, inhibiting their ability to supply oxygen and essential nutrients to these small nerves, leading to their deterioration. This effect is amplified because the nerve fibers that supply sweat glands are long, thin and unmyelinated, they are easily damaged. When the sweat glands and small nerve fibers lose functionality, it is a sign of starting peripheral neuropathy.

Diabetic peripheral neuropathy (DPN) affects the majority of patients with diabetes, but it is difficult to diagnose in its early stages because up to half of those affected are asymptomatic (no pain and good feet sensation). These undetected signs and lack of care can lead to Diabetic Foot Ulcer (DFU) and in the worst case to amputation(1). Though late stage DPN cannot be reversed, early detection can help to slow the progression through exercise, HbA1c control, addressing certain vitamin deficiencies, and other lifestyle changes. According to the American Academy of Family Physicians, early detection and treatment of DPN and resulting foot ulcers has the potential to prevent up to 85% of amputations (2,3).

Many studies have demonstrated the link between sudomotor function and the risk for DPN paving the way for the use of the Sudoscan within DPN characterization (4,5,6,7). ESC has now a 15+ year track record of R&D and a body of peer-reviewed research in more than 200 scientific publications. Because of this vast array of clinical evidence,Withings decided to integrate the ESC measurement into its scales leading to the Body Pro 2 device. To measure ESC, patients simply step on the Body Pro 2 scale (8). Electrodes in the scale emit a small painless current to the feet, and the device measures the resulting chloride conductance in the sweat glands. Within 60 seconds, patients and their providers receive their ESC score (and other biomarkers). Low conductance, and thus a low ESC score, indicates sudomotor dysfunction with a known threshold to stratify patients.

With a persistent DFU and amputation problem impacting millions of people with diabetes, it is clear that current clinical methods and patient compliance are insufficient to markedly reduce incidences. Even for patients who have their annual foot exam, the conventional monofilament test results in a misdiagnosis nearly half the time (9). Skin biopsies are conclusive, but invasive, painful, and especially problematic for patients who have a high risk of infection and whose wounds heal slowly. By contrast, our ESC technology provides a rapid, operator-independent, and reproducible method that can replace monofilament and balance the drawbacks of invasive biopsy.

While preventing DFUs is a complex problem requiring multi-faceted solutions, we are already working with leading providers in the U.S., Europe and Asia to enable easier and more reliable diagnosis and monitoring of DPN using the ESC technology in Body Pro 2. Importantly, we believe that the quantifiable, reproducible, rapid and non-invasive methodology has far more potential for scaling in proportion to the size of the DFU problem, and can better serve the requirements of a highly diverse patient population.

Armstrong, D. G., Tan, T.-W., Boulton, A. J. M. & Bus, S. A. Diabetic Foot Ulcers: A Review. JAMA 330, 62–75 (2023).https://jamanetwork.com/journals/jama/article-abstract/2806655 Hunt, D. Diabetes: Foot Ulcers and Amputations. Am. Fam. Physician 80, 789–790 (2009).https://www.aafp.org/pubs/afp/issues/2009/1015/p789.htmlEsquenazi, A., Kwasniewski, M. Lower Limb Amputations: Epidemiology and Assessment. PM&R KnowledgeNow (2017). https://now.aapmr.org/lower-limb-amputations-epidemiology-and-assessment/ Galiero, R. et al. Peripheral Neuropathy in Diabetes Mellitus: Pathogenetic Mechanisms and Diagnostic Options. Int. J. Mol. Sci. 24, 3554 (2023). https://doi.org/10.3390/ijms24043554 Casellini, C. M., Parson, H. K., Richardson, M. S., Nevoret, M. L. & Vinik, A. I. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol. Ther. 15, 948–953 (2013). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3817891/ Vinik, A. I., Nevoret, M.-L. & Casellini, C. The New Age of Sudomotor Function Testing: A Sensitive and Specific Biomarker for Diagnosis, Estimation of Severity, Monitoring Progression, and Regression in Response to Intervention. Front. Endocrinol. 6, 94 (2015). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4463960/Novak, P. Electrochemical skin conductance: a systematic review. Clin. Auton. Res. Off. J. Clin. Auton. Res. Soc. 29, 17–29 (2019). https://doi.org/10.1007/s10286-017-0467-x Riveline, J.-P. et al. Validation of the Body Scan®, a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan®. Front. Neurol. 14, (2023). https://doi.org/10.3389/fneur.2023.1256984 Dube, S. et al. Effectiveness of Semmes Weinstein 10 gm monofilament in diabetic peripheral neuropathy taking nerve conduction and autonomic function study as reference tests. J. Fam. Med. Prim. Care 11, 6204–6208 (2022). https://doi.org/10.4103/jfmpc.jfmpc_195_22

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