Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study with 453 Subjects
Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study with 453 Subjects
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DOI：
10.1089/dia.2011.0170
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发表时间：
2012-04-01
影响因子：
5.4
通讯作者：
Pfuetzner, Andreas
中科院分区：
文献类型：
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作者：
Tack, Cornelius;Pohlmeier, Harald;Pfuetzner, Andreas
背景：本多中心研究旨在评估最近推出的五种血糖监测设备在日常条件下的性能，并与YSI (Yellow Springs， OH) 2300 Stat Plus血糖分析仪进行比较。方法：501名有BG自我监测经验的糖尿病患者在日常环境中随机使用5种不同的BGM设备中的3种(FreeStyle Lite (R)[雅培糖尿病护理公司，加利福尼亚州阿拉米达]，FreeStyle Freedom Lite[雅培糖尿病护理公司]，OneTouch (R) UltraEasy (R) [LifeScan公司，加利福尼亚州Milpitas]， Accu-Chek （R) Aviva[罗氏诊断公司，曼海姆，德国]和Contour (R)[拜耳Vital GmbH，勒沃库森]）。所有装置和试纸都是从当地正规分销来源（药房，每个装置四批试纸）购买的。患者自行进行手指穿刺和血糖测量。同时，医疗保健专业人员使用参考方法（YSI 2300 Stat Plus）进行血糖评估。主要目的是比较平均绝对相对差异（MARD）。次要目标是在这些常规条件下符合国际标准化组织（ISO）的精度标准以及Clarke和Parkes误差网格分析。结果：MARD范围从4.9% （FreeStyle Lite）到9.7% （OneTouch UltraEasy）。FreeStyle Lite（98.8%）、FreeStyle Freedom Lite（97.5%）和Accu-Chek Aviva（97.0%）达到了ISO 15197: 2003的要求，但Contour（92.4%）和OneTouch UltraEasy（91.1%）没有达到要求。Clarke Error Grid分析A区值的数量在FreeStyle Lite中最高（98.8%），在OneTouch Ultra Easy中最低（90.4%）。结论：FreeStyle Lite、FreeStyle Freedom Lite和Accu-Chek Aviva在本研究中通过正规分销渠道购买的设备和试条表现非常好，其中FreeStyle Lite在本研究中获得了最低的MARD。
Background: This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) devices under daily routine conditions in comparison with the YSI (Yellow Springs, OH) 2300 Stat Plus glucose analyzer.Methods: Five hundred one diabetes patients with experience in self-monitoring of BG were randomized to use three of five different BGM devices (FreeStyle Lite (R) [Abbott Diabetes Care Inc., Alameda, CA], FreeStyle Freedom Lite [Abbott Diabetes Care], OneTouch (R) UltraEasy (R) [LifeScan Inc., Milpitas, CA], Accu-Chek (R) Aviva [Roche Diagnostics, Mannheim, Germany], and Contour (R) [Bayer Vital GmbH, Leverkusen, Germany]) in a daily routine setting. All devices and strips were purchased from local regular distribution sources (pharmacies, four strip lots per device). The patients performed the finger prick and the glucose measurement on their own. In parallel, a healthcare professional performed the glucose assessment with the reference method (YSI 2300 Stat Plus). The primary objective was the comparison of the mean absolute relative differences (MARD). Secondary objectives were compliance with the International Organization for Standardization (ISO) accuracy criteria under these routine conditions and Clarke and Parkes Error Grid analyses.Results: MARD ranged from 4.9% (FreeStyle Lite) to 9.7% (OneTouch UltraEasy). The ISO 15197: 2003 requirements were fulfilled by the FreeStyle Lite (98.8%), FreeStyle Freedom Lite (97.5%), and Accu-Chek Aviva (97.0%), but not by the Contour (92.4%) and OneTouch UltraEasy (91.1%). The number of values in Zone A of the Clarke Error Grid analysis was highest for the FreeStyle Lite (98.8%) and lowest for the OneTouch Ultra Easy (90.4%).Conclusions: FreeStyle Lite, FreeStyle Freedom Lite, and Accu-Chek Aviva performed very well in this study with devices and strips purchased through regular distribution channels, with the FreeStyle Lite achieving the lowest MARD in this investigation.