Fokkert M J, van Dijk P R, Edens M A, Abbes S, de Jong D, Slingerland R J, Bilo H J G
Department of Clinical Chemistry , Isala , Zwolle , The Netherlands.
Isala, Diabetes Center, Zwolle, The Netherlands; Department of Internal Medicine, Isala, Zwolle, The Netherlands.
BMJ Open Diabetes Res Care. 2017 Feb 17;5(1):e000320. doi: 10.1136/bmjdrc-2016-000320. eCollection 2017.
To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.
20 subjects (8 type 1 diabetes mellitus, 12 type 2 diabetes mellitus) were analyzed. FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2).
FSL-CGM arm sensor readings showed 85.5% of paired readings falling within Clarke Error Grid (ISO 15197:2013) zone A when compared with StatStrip. For FSL-CGM abdomen and FSLC, these percentages were 64% and 98%, respectively. The overall correlation of FSL-CGM in the arm and the StatStrip indicates a performance with lower results with the FSL-CGM in the arm than expected based on the StatStrip in the lower glucose ranges, and higher results than expected in the higher ranges. Following a standardized glucose load, a slower rise in glucose level was observed for FSL-CGM arm as compared with PCA-HK, StatStrip, FSLC, and iPro2 during the first 45-60 min after glucose load ingestion.
Certain matters need attention while using the FSL-CGM in daily life including the observed lower values in the lower ranges, and the underestimation of the effect of a meal on glucose response. These effects of such deviations can partly be overcome by optimizing the available user instructions.
TC5348; results.
评估FreeStyle Libre Flash连续血糖监测（FSL-CGM）系统相对于既定的中心实验室方法的性能。
对20名受试者（8名1型糖尿病患者，12名2型糖尿病患者）进行分析。将FSL-CGM传感器测量值（插入手臂和腹部）与使用StatStrip作为半金标准分析的毛细血管血糖结果进行比较。通过FSL-CGM测量标准化口服葡萄糖负荷后的血糖反应，并通过高氯酸己糖激酶（PCA-HK）法、StatStrip和FSL测试条（FSLC）以及常用的CGM系统（iPro2）分析毛细血管样本。
与StatStrip相比，FSL-CGM手臂传感器读数显示85.5%的配对读数落在克拉克误差网格（ISO 15197:2013）A区。对于FSL-CGM腹部和FSLC，这些百分比分别为64%和98%。FSL-CGM手臂与StatStrip的总体相关性表明，在较低血糖范围内，FSL-CGM手臂的性能结果低于基于StatStrip预期的结果，而在较高范围内则高于预期结果。在标准化葡萄糖负荷后，与PCA-HK、StatStrip、FSLC和iPro2相比，在摄入葡萄糖负荷后的前45-60分钟内，FSL-CGM手臂观察到葡萄糖水平上升较慢。
在日常生活中使用FSL-CGM时需要注意某些事项，包括在较低范围内观察到的值较低，以及对餐食对血糖反应的影响估计不足。通过优化现有的用户说明，可以部分克服此类偏差的影响。
TC5348；结果。
