The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.
The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.
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DOI：
10.1089/dia.2014.0378
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发表时间：
2015-11
影响因子：
5.4
通讯作者：
Alva S
中科院分区：
文献类型：
--
作者：
Bailey T;Bode BW;Christiansen MP;Klaff LJ;Alva S
简介：本研究旨在评价FreeStyle® Libre™ Flash血糖监测系统（Abbott Diabetes Care，阿拉米达，CA）用于间质血糖结果与毛细血管血糖结果的性能和可用性。材料和方法：72名1型或2型糖尿病患者参加了美国四个临床研究中心的研究。将传感器插入每个上臂的背部长达14天。研究中使用了三个仅在工厂校准的传感器批次。在3次临床访视（每次访视32份样本）时，将探头葡萄糖测量值与使用读取器内置血糖仪（BG参考）和YSI分析仪（Yellow Springs Instrument，Yellow Springs，OH）参考测试获得的毛细血管血糖（BG）结果（每天约8份）进行比较。传感器读数对参与者设盲。结果如下：根据毛细血管BG参考值证明了结果的准确性，86.7%的探头结果在共识误差网格区A内。第2、7和14天共识误差网格A区内的读数百分比分别为88.4%、89.2%和85.2%。总体平均绝对相对差异为11.4%。探头和YSI参考值之间的平均滞后时间为4.5±4.8 min。探头准确度不受体重指数、年龄、糖尿病类型、临床部位、胰岛素给药或血红蛋白A1 c等因素的影响。结论：与毛细血管BG参考值相比，FreeStyle Libre系统的间质葡萄糖测量结果准确，佩戴14天后准确度保持稳定，不受患者特征的影响。
Introduction: The purpose of the study was to evaluate the performance and usability of the FreeStyle® Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results. Materials and Methods: Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants. Results: The accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5±4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c. Conclusions: Interstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.