Department of Endocrinology, Metabolism and Diabetes, Faculty of Medicine, Kindai University, Osaka-sayama, Osaka, Japan.
J Diabetes Investig. 2020 Sep;11(5):1222-1229. doi: 10.1111/jdi.13229. Epub 2020 Mar 2.
AIMS/INTRODUCTION: A flash glucose monitoring (FGM) system has become available. To clarify the relationship between FGM and self-monitoring blood glucose (SMBG) values, we compared the two values after simultaneous measurement in Japanese patients with type 1 diabetes, under daily life settings.
A total of 20 outpatients with type 1 diabetes were analyzed. When FGM and SMBG were carried out simultaneously (within ±3 min), the values were adopted and each FGM value was matched and compared with the corresponding SMBG value. In addition, we analyzed other cases of simultaneity defined as "within ±2 min," "within ±1 min" and "at the exact same time."
The percentage of SMBG and FGM values in the clinically acceptable zone A + B in Clarke and consensus error grid analyses were 97.9 and 99.2%, respectively. Deming regression (x-axis: FGM values, y-axis: SMBG values) determined a slope of 0.9128 (95% confidence interval 0.9008-0.9247) and an intercept of +15.94 mg/dL (95% confidence interval 14.05-17.84). FGM values were lower than SMBG values in the lower glucose range, and higher in the higher glucose range. The shorter the time lag between measurements, the higher the rate of concordance between FGM and SMBG values.
The results of this study provided evidence on the reliability of FGM in Japanese patients with type 1 diabetes in home conditions. Based on the results, if an abnormal glucose value is detected by FGM, SBMG should then be used to confirm the result.
目的/引言:一种即时血糖监测(FGM)系统已经问世。为了阐明 FGM 与自我监测血糖(SMBG)值之间的关系,我们在日本 1 型糖尿病患者的日常生活环境中,同时测量这两种数值后进行了比较。
共分析了 20 名 1 型糖尿病门诊患者。当 FGM 和 SMBG 同时进行(在±3 分钟内)时,采用这两种数值,并将每个 FGM 值与相应的 SMBG 值相匹配和比较。此外,我们还分析了其他同时性案例,定义为“在±2 分钟内”、“在±1 分钟内”和“在同一时间”。
Clarke 和共识误差网格分析中 SMBG 和 FGM 值在临床可接受区 A+B 的百分比分别为 97.9%和 99.2%。Deming 回归(x 轴:FGM 值,y 轴:SMBG 值)确定斜率为 0.9128(95%置信区间 0.9008-0.9247),截距为+15.94mg/dL(95%置信区间 14.05-17.84)。FGM 值在较低的血糖范围内低于 SMBG 值,在较高的血糖范围内高于 SMBG 值。测量之间的时间滞后越短,FGM 和 SMBG 值之间的一致性率越高。
本研究结果为 1 型糖尿病日本患者在家中条件下使用 FGM 的可靠性提供了证据。基于这些结果,如果 FGM 检测到异常血糖值,则应使用 SMBG 来确认结果。