Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors
Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors
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DOI：
10.2337/dc17-1960
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发表时间：
2018-08-01
期刊：
影响因子：
16.2
通讯作者：
Kohn, Michael A.
中科院分区：
文献类型：
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作者：
Klonoff, David C.;Parkes, Joan Lee;Kohn, Michael A.
个人使用的清洁血糖仪（BGM）可能并不总是能够达到国际和美国监管机构目前规定的准确度水平。本研究的目的是评估美国食品和药物管理局批准的18种此类系统的准确性，这些系统代表了2013年至2015年使用的约90%的市售系统。035名受试者被招募到具有毛细血管血糖（BG）在六个不同的系统上测量水平，并在参考实验室制备用于血浆检测的参考毛细管样品。产品从消费者商店获得，并在三项三盲研究中进行测试。三个参与的临床研究中心分别对三项研究中的每项研究的不同的六个系统进行了循环测试。在每项研究中，平均有115名受试者接受了BGM测试。合规BG结果定义为在参考血浆值的15%范围内（对于BG >= 100 mg/dL [5.55 mmol/L]）或在15 mg/dL范围内（0.83 mmol/L）（对于BG 20%;改良的Bland-Altman分析，包括平均偏倚、变异系数和95%一致性限度;和无临床风险的读数比例，由监督误差网格确定。不同的准确性指标产生几乎相同的BGM排名。在所有3项研究中，18个系统中有6个符合预定准确度标准，5个系统在2项研究中符合预定准确度标准，3个系统在1项研究中符合预定准确度标准。四个BGM不符合准确性标准的任何三个study.CONCLUSIONSCleared BGM并不总是符合目前所需的监管许可的分析准确性水平。这些信息可以帮助患者、专业人员和付款人选择产品，并帮助监管机构评估批准后的性能。
OBJECTIVECleared blood glucose monitors (BGMs) for personal use may not always deliver levels of accuracy currently specified by international and U.S. regulatory bodies. This study's objective was to assess the accuracy of 18 such systems cleared by the U.S. Food and Drug Administration representing approximately 90% of commercially available systems used from 2013 to 2015.RESEARCH DESIGN AND METHODSA total of 1,035 subjects were recruited to have a capillary blood glucose (BG) level measured on six different systems and a reference capillary sample prepared for plasma testing at a reference laboratory. Products were obtained from consumer outlets and tested in three triple-blinded studies. Each of the three participating clinical sites tested a different set of six systems for each of the three studies in a round-robin. In each study, on average, a BGM was tested on 115 subjects. A compliant BG result was defined as within 15% of a reference plasma value (for BG >= 100 mg/dL [5.55 mmol/L]) or within 15 mg/dL (0.83 mmol/L) (for BG 20%; modified Bland-Altman analysis including average bias, coefficient of variation, and 95% limits of agreement; and proportion of readings with no clinical risk as determined by the Surveillance Error Grid.RESULTSThe different accuracy metrics produced almost identical BGM rankings. Six of the 18 systems met the predetermined accuracy standard in all three studies, 5 systems met it in two studies, and 3 met it in one study. Four BGMs did not meet the accuracy standard in any of the three studies.CONCLUSIONSCleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance. This information could assist patients, professionals, and payers in choosing products and regulators in evaluating postclearance performance.