第三代14天连续血糖监测系统的准确性
Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System.
作者信息
Alva Shridhara, Brazg Ronald, Castorino Kristin, Kipnes Mark, Liljenquist David R, Liu Hanqing
机构信息
Abbott Diabetes Care, Alameda, CA, USA.
Rainier Clinical Research Center, Renton, WA, USA.
出版信息
Diabetes Ther. 2023 Apr;14(4):767-776. doi: 10.1007/s13300-023-01385-6. Epub 2023 Mar 6.
INTRODUCTION
We have evaluated the performance of the FreeStyle Libre® 3 continuous glucose monitoring system (FSL3) compared to (1) the venous plasma reference for participants aged ≥ 6 years and (2) the fingerstick capillary blood glucose (BG) reference for pediatric participants aged 4 and 5 years. The analytical performance of the third-generation factory-calibrated FSL3 CGM system was compared to the plasma venous blood glucose reference using the YSI 2300 STAT PLUS Glucose and Lactate Analyzer (the YSI reference) and the self-monitoring blood glucose (SMBG) reference for participants aged ≥ 6 years and participants aged 4 and 5 years, respectively.
METHODS
A total of 108 participants aged ≥ 4 years with type 1 or type 2 diabetes from four sites in the USA were enrolled in the study. The data of 100 participants were ultimately evaluated. Adult participants (aged ≥ 18 years) participated in three in-clinic sessions, and pediatric participants (aged 4-17 years) participated in up to two in-clinic sessions, all stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13 or 14 of sensor wear. Performance evaluation included accuracy measures, such as proportion of CGM values that fell within ± 20% or ± 20 mg/dL (1.1 mmol/L) of the reference glucose values, and difference measures, such as the mean absolute relative difference (MARD) between the CGM and reference values.
RESULTS
Data from the 100 study participants were analyzed. The overall MARD was 7.8%, and 93.4% of the CGM values were within ± 20% or ± 20 mg/dL of the YSI reference for participants aged ≥ 6 years, with 6845 CGM-YSI matched pairs. The performance was stable over the 14-day wear period. For participants aged 4-5 years, MARD was 10.0%, and 88.9% of the CGM values were within 20%/20 mg/dL compared to a SMBG reference. No serious adverse events were reported.
CONCLUSIONS
The FSL3 CGM system demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period.
引言
我们评估了FreeStyle Libre® 3连续血糖监测系统（FSL3）与以下两者相比的性能：（1）年龄≥6岁参与者的静脉血浆参考值；（2）4岁和5岁儿科参与者的指尖毛细血管血糖（BG）参考值。使用YSI 2300 STAT PLUS葡萄糖和乳酸分析仪（YSI参考值）以及分别针对年龄≥6岁参与者和4岁及5岁参与者的自我监测血糖（SMBG）参考值，将第三代工厂校准的FSL3连续血糖监测系统的分析性能与血浆静脉血糖参考值进行比较。
方法
来自美国四个地点的108名年龄≥4岁的1型或2型糖尿病患者参与了该研究。最终对100名参与者的数据进行了评估。成年参与者（年龄≥18岁）参加了三次门诊检查，儿科参与者（年龄4 - 17岁）参加了最多两次门诊检查，所有检查均进行分层，以提供传感器佩戴第1、2、3、7、8、9、12、13或14天的数据。性能评估包括准确性指标，如连续血糖监测（CGM）值落在参考血糖值±20%或±20 mg/dL（1.1 mmol/L）范围内的比例，以及差异指标，如CGM值与参考值之间的平均绝对相对差异（MARD）。
结果
对100名研究参与者的数据进行了分析。总体MARD为7.8%，对于年龄≥6岁的参与者，93.4%的CGM值在YSI参考值的±20%或±20 mg/dL范围内，共有6845对CGM - YSI匹配数据对。在14天的佩戴期内性能稳定。对于4 - 5岁的参与者，与SMBG参考值相比，MARD为10.0%，88.9%的CGM值在20%/20 mg/dL范围内。未报告严重不良事件。
结论
FSL3连续血糖监测系统在14天的传感器佩戴期内，在动态血糖范围内表现出准确的性能。
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