[1]林金香,陈小燕,颜建华,等.新型远程动态血糖监测系统的准确性及安全性研究[J].国际内分泌代谢杂志,2021,41(02):105-109，132.[doi:10.3760/cma.j.cn121383-20200611-06032]
　Lin Jinxiang,Chen Xiaoyan,Yan Jianhua,et al.Research on the accuracy and safety of a new remote continuous glucose monitoring system[J].International Journal of Endocrinology and Metabolism,2021,41(02):105-109，132.[doi:10.3760/cma.j.cn121383-20200611-06032]
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新型远程动态血糖监测系统的准确性及安全性研究()
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《国际内分泌代谢杂志》[ISSN:1673-4157/CN:12-1383/R]

卷:
41
期数:
2021年02期
页码:
105-109，132
栏目:
论著
出版日期:
2021-03-20

文章信息/Info

Title:
Research on the accuracy and safety of a new remote continuous glucose monitoring system
作者:
林金香1; 3; 陈小燕1; 颜建华2; 陈婉玲1; 黄连意1; 邓顺有1; 李淑华1
1广州医科大学附属第一医院内分泌科 510120; 2上海健康医学院 200120; 3中山市人民医院,中山大学附属中山医院 528403
Author(s):
Lin Jinxiang1; 3;  Chen Xiaoyan1;  Yan Jianhua2;  Chen Wanling1;  Huang Lianyi1;  Deng Shunyou1;  Li Shuhua1.
1The First Affiliated Hospital of GuangZhou Medical University, Guangzhou 510120, China; 2Shanghai University of Medicine & Health Sciences, Shanghai, 200120, China; 3Zhongshan City People's Hospital, Zhongshan Hospita
关键词:
远程监测;  动态血糖监测系统;  糖尿病;  准确性
Keywords:
Remote monitoring;  Continuous glucose monitoring system;  Diabetes mellitus;  Accuracy
DOI:
10.3760/cma.j.cn121383-20200611-06032
摘要:
目的 探讨新型远程动态血糖监测系统(continuous glucose monitoring system,CGMS)iWel NR 在糖尿病及高危人群中使用的准确性及安全性。方法 纳入患者60例,分为2组,组1共48例单独佩戴iWel NR 7 d,组2共12例同时佩戴iWel NR、Guardian RT(实时动态血糖监测系统)3 d,收集同时刻配对的CGM-自我监测指尖血糖(SMBG)值,采用相关系数(r)、平均绝对差值的相对数(MARD)、绝对差值相对数的中位数(MedARD)、偏差一致率分析iWel NR数据的准确性,Clarke误差栅格分析(Clarke-EGA)分析临床准确性。所有患者完成调查问卷一份,用于评估iWel NR的安全性。结果 60例患者共收集到833对CGM-SMBG值,相关系数r=0.88,P<0.01; MARD 为13.06%,MedARD为10.84%; 与SMBG值相比,在20%、30%、40%的偏差一致率分别为78.0%、93.2%、97.4%; Clarke-EGA显示A+B区占98.9%。与Guardian RT的头对头研究中,12例患者共收集115对CGM-SMBG值,Guardian RT的MARD、MedARD分别为12.59%,9.54%,iWel NR的MARD、MedARD分别为10.35%、8.01%。进一步按SMBG值进行分层,提示SMBG值在3.9～10 mmol/L时,iWel-NR的MARD、MedARD最低,Clarke-EGA中A+B区占比最高。60份问卷结果提示未发生不良安全事件。结论 iWel NR具有较高的准确性及良好的安全性,其准确性稍高于Guardian RT; iWel NR的准确性受血糖水平的影响,血糖越接近理想范围时,准确性越高。
Abstract:
Objective To explore the accuracy and safety of a new remote continuous glucose monitoring system(CGMS)iWel NR in diabetes mellitus and high-risk population.Methods A 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.Results A 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.Conclusions iWel 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.

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备注/Memo

备注/Memo:
通信作者:陈小燕,Email:gzscxy@126.com
更新日期/Last Update: 2021-03-20