Understanding our ESC and DPN
Understanding our ESC Technology for Detecting and Monitoring DPN
了解我們用於檢測和監控 DPN 的 ESC 技術April 16, 2024 2024 年 4 月 16 日4 min readElectrochemical 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.
電化學皮膚電導 (ESC) 是一種生理參數，用於測量汗腺和皮膚小神經纖維對電刺激的反應。血糖水平升高會損害血管，抑制血管向這些小神經供應氧氣和必需營養的能力，導致其惡化。這種效應被放大，因為供應汗腺的神經纖維又長又細且無髓鞘，很容易受損。當汗腺和小神經纖維失去功能時，這是周邊神經病變開始的跡象。
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).
糖尿病週邊神經病變 (DPN) 影響大多數糖尿病患者，但在早期階段很難診斷，因為多達一半的患者沒有症狀（無疼痛且足部感覺良好）。這些未被發現的症狀和缺乏護理可能會導致糖尿病足潰瘍 (DFU)，最糟的情況會導致截肢(1)。雖然晚期 DPN 無法逆轉，但早期發現可以透過運動、控制 HbA1c、解決某些維生素缺乏症和其他生活方式改變來幫助減緩進展。據美國家庭醫師學會稱，早期發現並治療 DPN 及其引起的足部潰瘍有可能預防高達 85% 的截肢 (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.
許多研究已證明促汗功能與 DPN 風險之間的聯繫，為在 DPN 表徵中使用 Sudoscan 鋪平了道路 (4,5,6,7)。 ESC 目前擁有 15 年以上的研發記錄，並在 200 多份科學出版物中發表了一系列經過同行評審的研究。由於大量的臨床證據，Withings 決定將 ESC 測量整合到其體重計中，從而開發出 Body Pro 2 設備。要測量 ESC，患者只需踩在 Body Pro 2 秤上 (8)。體重計中的電極會向腳部發射微小的無痛電流，該設備測量汗腺中產生的氯化物電導。 60 秒內，患者及其提供者就會收到他們的 ESC 評分（和其他生物標記）。電導率低，ESC 評分低，表示排汗功能障礙，具有已知的閾值來對患者進行分層。
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.
由於持續存在的 DFU 和截肢問題影響著數百萬名糖尿病患者，顯然目前的臨床方法和患者依從性不足以顯著降低發病率。即使是每年進行足部檢查的患者，傳統的單絲測試也會導致近一半的誤診 (9)。皮膚切片是決定性的，但具有侵入性、痛苦，對於感染風險高且傷口癒合緩慢的患者來說尤其成問題。相較之下，我們的 ESC 技術提供了一種快速、獨立於操作員且可重複的方法，可以取代單絲並平衡侵入性活檢的缺點。
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.
雖然預防DFU 是一個複雜的問題，需要多方面的解決方案，但我們已經與美國、歐洲和亞洲的領先供應商合作，使用Body Pro 2 中的ESC 技術更輕鬆、更可靠地診斷和監測DPN。重要的是，我們相信可量化、可重複、快速和非侵入性的方法具有更大的潛力，可以根據 DFU 問題的規模進行擴展，並且可以更好地滿足高度多樣化的患者群體的需求。 References 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.html Esquenazi, 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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