Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Nov 15, 2020; 11(11): 489-500
Published online Nov 15, 2020. doi: 10.4239/wjd.v11.i11.489
Continuous glucose monitoring defined time-in-range is associated with sudomotor dysfunction in type 2 diabetes
Qing-Yu Guo, Bin Lu, Zhan-Hong Guo, Zhou-Qin Feng, Yan-Yu Yuan, Xu-Guang Jin, Pu Zang, Ping Gu, Jia-Qing Shao
Qing-Yu Guo, Bin Lu, Xu-Guang Jin, Pu Zang, Ping Gu, Jia-Qing Shao, Department of Endocrinology, Jinling Hospital, School of Medicine, Nanjing University, Nanjing 210002, Jiangsu Province, China
Zhan-Hong Guo, Yan-Yu Yuan, Department of Endocrinology, Jinling Hospital, Nanjing Medical University, Nanjing 210002, Jiangsu Province, China
Zhou-Qin Feng, Department of Endocrinology, Jinling Hospital, Southern Medical University, Nanjing 210002, Jiangsu Province, China
Author contributions: Guo QY, Lu B, and Gu P conceived and designed the research; Guo QY and Guo ZH analyzed and interpreted the data; Guo QY, Feng ZQ, Yuan YY, and Jin XG performed the statistical analysis; Guo QY wrote the manuscript; Zang P and Shao JQ critically revised the manuscript for key intellectual content; Guo QY was responsible for the integrity of the work; all authors read and approved the final manuscript.
Supported by National Natural Science Foundation of China, No. 81774134 and No. 81873174; Natural Science Foundation of Jiangsu Province of China, No. BK20150558 and No. BK20171331; Postdoctoral Foundation of Jiangsu Province of China, No. 1501120C; Jiangsu Province 333 Talent Funding Project, No. BRA2017595; and Young Medical Key Talents Project of Jiangsu Province, No. QNRC2016902.
Institutional review board statement: The study was approved by the Institutional Review Board (IRB) of Jinling Hospital, Nanjing University and was performed according to the Declaration of Helsinki.
Informed consent statement: This study is a cross-sectional study, so it is not applicable.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest to disclose.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding authors and the senior author on reasonable request.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Jia-Qing Shao, MD, PhD, Chief Doctor, Professor, Department of Endocrinology, Jinling Hospital, School of Medicine, Nanjing University, No. 305 East Zhongshan Road, Nanjing 210002, Jiangsu Province, China. shaojiaqing@nju.edu.cn
Received: July 27, 2020
Peer-review started: July 27, 2020
First decision: August 9, 2020
Revised: August 21, 2020
Accepted: September 18, 2020
Article in press: September 18, 2020
Published online: November 15, 2020
Processing time: 108 Days and 20.1 Hours
ARTICLE HIGHLIGHTS
Research background

Previous research showed that up to 50% of diabetic individuals were affected by diabetic peripheral neuropathy (DPN). SUDOSCAN (Impeto Medical, Paris, France) is an emerging technique for the detection of DPN through detecting sudomotor function of the sweat gland. Sudomotor dysfunction, derived by SUDOSCAN, could detect DPN in the inchoate stage. The measurement of SUDOSCAN includes electrochemical skin conductance in hands (HESC, measured in μS) and feet (FESC). The exact pathogenesis of DPN is not fully clarified. The researchers identified glycemic variability as an independent contributor to DPN. Time in range (TIR), as a CGM-derived pivotal metric, has been proved to assess short-lived glycemic control. A lower level of TIR had an adverse effect in patients who were diagnosed with diabetes mellitus with diabetic microvascular complications, including microalbuminuria and retinopathy. But the association between TIR and sudomotor dysfunction has not explored clearly yet.

Research motivation

In this study, we aimed to explore the correlation between TIR calculated by continuous glucose monitoring (CGM) and sudomotor dysfunction detected by SUDOSCAN in Chinese subjects with type 2 diabetes mellitus (T2DM).

Research objectives

Our aim was to provide a novel and objective metric to monitor glycemic control in patients with T2DM, especially those who have combined complications.

Research methods

This study enrolled 466 inpatients with type 2 diabetes. All subjects underwent 3-d CGM and SUDOSCAN. SUDOSCAN was assessed with electrochemical skin conductance in hands (HESC) and feet (FESC). Average feet ESC < 60 µS was defined as sudomotor dysfunction (+), otherwise it was sudomotor dysfunction (-). TIR refers to the percentage of time when blood glucose is between 3.9-10 mmol/L during a 1-d period. First, we compared clinical variables between the sudomotor dysfunction (-) and sudomotor dysfunction (+) groups. Next, in order to perform more in-depth analyses of the association between TIR and sudomotor dysfunction, we further stratified all participants based on tertiles of TIR. And the prevalence of sudomotor dysfunction in different tertiles of TIR was compared. Next, Spearman’s rank correlation was carried out to evaluate the association of TBR, TIR, or TAR and SUDOSCAN metrics. And binary logistic regression analysis was applied to explore the link between TIR (as a continuous or categorical variable) and sudomotor dysfunction after adjusting for clinical factors including age, diabetes duration, sex, BMI, SBP, DBP, smoking, TG, TC, HbA1c, as well as glycemic variability metrics. A P value < 0.01 was considered statistically significant.

Research results

Among 466 T2DM subjects, 135 (28.97%) presented with sudomotor dysfunction. Patients who had combined sudomotor dysfunction had a lower value of TIR (P < 0.001). Compared with the lowest tertile of TIR (T1 group), the middle tertile of TIR (T2 group) and the highest tertile of TIR (T3 group) were associated with an obviously lower prevalence of sudomotor dysfunction (20.51%, 21.94% vs 44.52%, P < 0.001). In addition, TIR was linked with SUDOSCAN indicators like FESC and HESC. With the increase of TIR, HESC and FESC increased (P < 0.001). The regression analysis demonstrated that TIR was inversely and independently linked with the prevalence of sudomotor dysfunction after adjusting for confounding factors (odds ratio = 0.979, 95%CI: 0.971-0.987, P < 0.001).

Research conclusions

Patients who have combined sudomotor dysfunction have a lower value of TIR. TIR is linked with SUDOSCAN indicators like FESC, HESC, HASYM, and FASYM robustly. TIR is inversely associated with the prevalence of sudomotor dysfunction independent of HbA1c.

Research perspectives

This is the first study to investigate the association between TIR and sudomotor dysfunction assessed by SUDOSCAN. These results will interest researchers in the prevalence and management of DPN. The preliminary data from our study may provide a basis for future large-sample, multi-center research.