Original Article
Research on the accuracy and safety of a new remote continuous glucose monitoring system
Lin Jinxiang, Chen Xiaoyan, Yan Jianhua, Chen Wanling, Huang Lianyi, Deng Shunyou, Li Shuhua
Published 2021-03-20
Cite as Int J Endocrinol Metab, 2021, 41(2): 105-109,132. DOI: 10.3760/cma.j.cn121383-20200611-06032
Abstract
ObjectiveTo explore the accuracy and safety of a new remote continuous glucose monitoring system(CGMS)iWel NR in diabetes mellitus and high-risk population.
MethodsA total of 60 patients were randomly divided into two groups. The first group, 48 patients wore iWel NR to the arms for 7 days. The second group, 12 patients wore iWel NR and Guardian RT at the same time for 3 days. The matching CGMS-self-monitoring of blood glucose(SMBG) values were collected. Pearson correlation analysis, Mean absolute relative difference(MARD), Median absolute relative difference(MedARD), Deviation consistency rate were used to analyze the data accuracy of iWel NR, and the clinical accuracy was tested by Clarke error grid analysis(Clarke-EGA). At the end of the trial, all patients completed a questionnaire to evaluate the safety of iWel NR.
ResultsA total of 833 matching data points were identified from 60 patients, r=0.88, P<0.01. The MARD was 13.06%, and the MedARD was 10.84%. Compared with SMBG, the deviation of 20%, 30% and 40% were 78.0%, 93.2% and 97.4%, respectively. Clarke error grid analysis showed that 98.9% of the data pairs from iWel NR fell into zone A+ B. In the head-to-head study of iWel NR and Guardian RT, 115 matching data points were collected from 12 patients. The MARD and MedARD of Guardian RT were 12.59%, 9.54%, and MARD and MedARD of iWel NR were 10.35%, 8.01%, respectively.Further, the SMBG value was divided into three groups. It suggested that when SMBG value was 3.9-10 mmol/L, MARD and MedARD of iWel NR were the lowest, and zone A+ B accounted for the highest proportion in Clarke EGA. No adverse safety events were found in 60 patients.
ConclusionsiWel NR has significant accuracy and safety. Compared with the Guardian RT of Medtroni Company, the accuracy of iWel NR is slightly higher. Its accuracy is affected by the level of blood glucose. The closer to the normal range of blood glucose, the higher the accuracy.
Key words:
Remote monitoring; Continuous glucose monitoring system; Diabetes mellitus; Accuracy
Contributor Information
Lin Jinxiang
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
Zhongshan City People′s Hospital, Zhongshan Hospital of Sun Yat-sen University, Zhong Shan 528403, China
Chen Xiaoyan
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
Yan Jianhua
Shanghai University of Medicine &
Health Sciences, Shanghai, 200120, China
Chen Wanling
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
Huang Lianyi
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
Deng Shunyou
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
Li Shuhua
The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China
