학술논문
Validation of the Body Scan ® , a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan ® .
Document Type
Academic Journal
Author
Riveline JP; Diabetology and Endocrinology Department, Lariboisière Hospital, Paris, France.; Mallone R; Diabetology Department, Cochin Hospital, Paris, France.; Tiercelin C; Diabetology Department, Cochin Hospital, Paris, France.; Yaker F; Diabetology Department, Cochin Hospital, Paris, France.; Alexandre-Heymann L; Diabetology Department, Cochin Hospital, Paris, France.; Khelifaoui L; Diabetology - Endocrinology and Nutrition Department, Bichat-Claude-Bernard Hospital, Paris, France.; Travert F; Diabetology - Endocrinology and Nutrition Department, Bichat-Claude-Bernard Hospital, Paris, France.; Fertichon C; Diabetology - Endocrinology and Nutrition Department, Bichat-Claude-Bernard Hospital, Paris, France.; Julla JB; Diabetology and Endocrinology Department, Lariboisière Hospital, Paris, France.; Vidal-Trecan T; Diabetology and Endocrinology Department, Lariboisière Hospital, Paris, France.; Potier L; Diabetology - Endocrinology and Nutrition Department, Bichat-Claude-Bernard Hospital, Paris, France.; Gautier JF; Diabetology and Endocrinology Department, Lariboisière Hospital, Paris, France.; Larger E; Diabetology Department, Cochin Hospital, Paris, France.; Lefaucheur JP; Unité de Neurophysiologie Clinique, Hôpital Henri Mondor, AP-HP, Créteil, France.; EA4391 (ENT), Faculté de Santé, Université Paris Est Créteil, Créteil, France.
Source
Publisher: Frontiers Research Foundation Country of Publication: Switzerland NLM ID: 101546899 Publication Model: eCollection Cited Medium: Print ISSN: 1664-2295 (Print) Linking ISSN: 16642295 NLM ISO Abbreviation: Front Neurol Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
1664-2295
Abstract
Background: Sudomotor dysfunction is one of the earliest manifestations of small fiber neuropathy (SFN), reflecting the alteration of sympathetic C fiber innervation of the sweat glands. Among other techniques, such innervation can be assessed by measuring electrochemical skin conductance (ESC) in microsiemens (μS). In this study, ESC was measured at the feet to detect distal SFN. For this objective, the performance of a new device, the Body Scan ® (Withings, France), intended for home use, was compared with that of a reference device, the Sudoscan ® (Impeto Medical, France), which requires a hospital setting.
Methods: In patients with diabetes with or without neuropathy or non-diabetic patients with lower-limb neuropathy, the diagnostic performance of the Body Scan® measurement was assessed by calculating its sensitivity (Se) and specificity (Sp) to detect at least moderate SFN (Se70 and Sp70), defined by a value of feet ESC ≤ 70 μS and > 50 μS on the Sudoscan ® measure, or severe SFN (Se50 and Sp50), defined by a value of feet ESC ≤ 50 μS on the Sudoscan ® measure. The agreement between the two devices was assessed with the analysis of Bland-Altman plots, mean absolute error (MAE), and root mean squared error (RMSE) calculations. The repeatability of the measurements was also compared between the two devices.
Results: A total of 147 patients (52% men, mean age 59 years old, 76% diabetic) were included in the analysis. The sensitivity and specificity to detect at least moderate or severe SFN were: Se70 = 0.91 ([0.83, 0.96]), Sp70 = 0.97 ([0.88, 0.99]), Se50 = 0.91 ([0.80, 0.98]), and Sp50 = 0.99 ([0.94, 1]), respectively. The bias and 95% limits of agreement were 1.5 [-5.4, 8.4]. The MAE was 2.9 and the RMSE 3.8. The intra-sample variability was 2.0 for the Body Scan® and 2.3 for the Sudoscan ® .
Conclusion: The ESC measurements provided by the Body Scan® were in almost perfect agreement with those provided by the reference device, the Sudoscan ® , which validates the accuracy of the Body Scan ® for the detection of SFN. By enabling simple, rapid, and autonomous use by the patient at home, this new technique will facilitate screening and monitoring of SFN in daily practice.
Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05178459.
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.
(Copyright © 2023 Riveline, Mallone, Tiercelin, Yaker, Alexandre-Heymann, Khelifaoui, Travert, Fertichon, Julla, Vidal-Trecan, Potier, Gautier, Larger and Lefaucheur.)
Methods: In patients with diabetes with or without neuropathy or non-diabetic patients with lower-limb neuropathy, the diagnostic performance of the Body Scan
Results: A total of 147 patients (52% men, mean age 59 years old, 76% diabetic) were included in the analysis. The sensitivity and specificity to detect at least moderate or severe SFN were: Se70 = 0.91 ([0.83, 0.96]), Sp70 = 0.97 ([0.88, 0.99]), Se50 = 0.91 ([0.80, 0.98]), and Sp50 = 0.99 ([0.94, 1]), respectively. The bias and 95% limits of agreement were 1.5 [-5.4, 8.4]. The MAE was 2.9 and the RMSE 3.8. The intra-sample variability was 2.0 for the Body Scan
Conclusion: The ESC measurements provided by the Body Scan
Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05178459.
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.
(Copyright © 2023 Riveline, Mallone, Tiercelin, Yaker, Alexandre-Heymann, Khelifaoui, Travert, Fertichon, Julla, Vidal-Trecan, Potier, Gautier, Larger and Lefaucheur.)