新型远程动态血糖监测系统的准确性及安全性研究

Research on the accuracy and safety of a new remote continuous glucose monitoring system

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(SMBC)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Wel 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。

Objective To explore the accuracy and safety of a new remote continuous glucose moni-toring system(CCMS)iWel NR in diabetes mellitus and high-risk population.Methods A total of 60 pa-tients were randomly divided into two groups.The first group,48 patients wore iWel NR to the arms for 7days.The second group,12 patients wore iWel NR and Guardian RT at the same time for 3 days.The matc-hing CGMS-self-monitoring of blood glucose(SMBG)values were collected.Pearson correlation analysis,Mean absolute relative difference(MARD),Median absolute relative difference(MedARD),Deviation con-sistency rate were used to analyze the data accuracy of iWel NR,and the clinical accuracy was tested byClarke error grid analysis(Clarke-EGA).At the end of the trial,all patients completed a questionnaire toevaluate the safety of iWel NR.Results A total of 833 matching data points were identified from 60patients,r=0.88,P<0.01.The MARD was 13.06%,and the MedARD was 10.84%.Compared withSMBG,the deviation of 20%,30%and 40%were 78.0%,93.2%and 97.4%,respectively.Clarke errorgrid analysis showed that 98.9%of the data pairs from iWel NR fell into zone A+B.In the head-to-headstudy of iWel NR and Guardian RT,115 matching data points were collected from l2 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%e,respectively.Further,the SMBG value was divided into three groups.It suggested that when SMBGvalue was 3.9-10 mmoL/L,MARD and MedARD of iWel NR were the lowest,and zone A+B accounted forthe 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 ac-curacy of iWel NR is slightly higher.Its accuracy is affected by the level of blood glucose.The closer to thenormal range of blood glucose,the higher the accuracy.