实时动态血糖监测系统性能的临床评价

Evaluation on the accuracy of real time continuous glucose monitoring system in clinic

目的评价实时动态血糖监测系统(GuardianRT CGMS)在血糖监测中的精确性。方法60例糖尿病患者佩戴GuardianRT CGMS 3d,应用相关系数、血糖误差分析表格(EGA)等指标评价其精确性。结果(1)在总体、高、中血糖水平,相匹配的GuardianRT CGMS血糖值与指血血糖值的相关系数分别为0.97、0.95、0.91(P均<0.001);在低血糖水平,两者相关性下降(r=0.61,P<0.01)。(2)相匹配的GuardianRT CGMS测定值与静脉血糖值相关系数为0.95(P<0.001)。(3)EGA显示,99.72%的结果在A区和B区。(4)GuardianRT CGMS高低血糖报警设置在13.2mmol/L和5.3mmol/L时,敏感性均为85%,特异性分别为99.4%和92%。结论GuardianRT CGMS在血糖监测方面有实时显示血糖值、精密度高、高低血糖的预警报警等优点,可在临床使用。

Objective To evaluate the accuracy of MiniMed Guardian RT CGMS in blood glucose measurement. Methods Totally 60 diabetic patients were used Guardian RT CGMS for 3 days. Using correlation coefficient and error grid analysis （EGA） assessed the accuracy of Guardian RT CGMS. Results （1）The correlation coefficient, between sensor glucose and capillary glucose values in general,higher and median glucose level were 0.97,0.95,0.91 respectively（P〈0.001）. The correlation was 0.61 in lower glucose level（P〈0.01 ）. （2）The correlation coefficient,between sensor glucose and plasma glucose values in general glucose level were 0.95 （P〈0.001）. （3）The analysis results of EGA showed that 99.72% of the data fell in the A and B zones. （4）Setting the low alert threshold to 5.3 mmol/L,results in 85% sensitivity,99.4% specificity. Setting the high alert threshold to 13.2 mmol/L,results in 85% sensitivity, 92% specificity. Conclusions Guardian RT CGMS has some advantages in blood glucose monitoring, such as offering blood glucose excursion in real time, setting low and high alerts. It can be used in clinic.