Accuracy and Reliability of Continuous Glucose Monitoring Systems: A Head-to-Head Comparison
Accuracy and Reliability of Continuous Glucose Monitoring Systems: A Head-to-Head Comparison
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DOI：
10.1089/dia.2013.0049
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发表时间：
2013-08-01
影响因子：
5.4
通讯作者：
DeVries, J. Hans
中科院分区：
文献类型：
--
作者：
Luijf, Yoeri M.;Mader, Julia K.;DeVries, J. Hans
目的：评价三种连续血糖监测（CGM）系统的准确性和可靠性。研究设计和方法：我们对20例1型糖尿病患者进行了Animas (R) (West Chester， PA) Vibe （TM）与Dexcom (R) (San Diego， CA) G4 （TM）版本A传感器（G4A）、Abbott Diabetes Care (Alameda， CA) Freestyle (R) Navigator I （NAV）和Medtronic (Northridge， CA) Paradigm (R)与Enlite （TM）传感器（ENL）的研究。所有系统都在临床研究中心（CRC）和家中进行了调查。在结直肠癌中，患者接受延迟和增加胰岛素剂量的膳食，以诱导餐后血糖峰值和最低点。此后，随机决定三个系统中的哪两个将在家中佩戴，直到功能结束，尝试使用超过制造商规定的使用寿命。患者每天至少进行5次参考指扎。对间隔15分钟的所有数据点进行方差分析。结果：CRC测量的总体平均绝对相对差（MARD） （SD） NAV为16.5% (14.3%)，ENL为16.4%(15.6%)，优于G4A的20.5% (18.2%)（P < 0.001）。在家中评估时，NAV的总体MARD为14.5% (16.7%)，G4A为16.5%(18.8%)，优于ENL的18.9% (23.6%)（P = 0.006）。到功能结束的中位时间相似：G4A组10.0（1.0）天，NAV组8.0（3.5）天，ENL组8.0（1.5）天（P = 0.119）。结论：在CRC中，G4A的准确性低于NAV和ENL传感器，两者似乎具有可比性。然而，在国内，ENL不如NAV和G4A准确。此外，CGM系统通常显示出足够的精度，可以在制造商规定的使用寿命之外使用。
Objective: This study assessed the accuracy and reliability of three continuous glucose monitoring (CGM) systems.Research Design and Methods: We studied the Animas (R) (West Chester, PA) Vibe (TM) with Dexcom (R) (San Diego, CA) G4 (TM) version A sensor (G4A), the Abbott Diabetes Care (Alameda, CA) Freestyle (R) Navigator I (NAV), and the Medtronic (Northridge, CA) Paradigm (R) with Enlite (TM) sensor (ENL) in 20 patients with type 1 diabetes mellitus. All systems were investigated both in a clinical research center (CRC) and at home. In the CRC, patients received a meal with a delayed and increased insulin dose to induce a postprandial glucose peak and nadir. Hereafter, randomization determined which two of the three systems would be worn at home until the end of functioning, attempting use beyond manufacturer-specified lifetime. Patients performed at least five reference finger sticks per day. An analysis of variance was performed on all data points 15min apart.Results: Overall average mean absolute relative difference (MARD) (SD) measured at the CRC was 16.5% (14.3%) for NAV and 16.4% (15.6%) for ENL, outperforming G4A at 20.5% (18.2%) (P < 0.001). Overall MARD when assessed at home was 14.5% (16.7%) for NAV and 16.5 (18.8%) for G4A, outperforming ENL at 18.9% (23.6%) (P = 0.006). Median time until end of functioning was similar: 10.0 (1.0) days for G4A, 8.0 (3.5) days for NAV, and 8.0 (1.5) days for ENL (P = 0.119).Conclusions: In the CRC, G4A was less accurate than NAV and ENL sensors, which seemed comparable. However, at home, ENL was less accurate than NAV and G4A. Moreover, CGM systems often show sufficient accuracy to be used beyond manufacturer-specified lifetime.