Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes
Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes
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DOI：
10.1111/dom.12907
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发表时间：
2017-07-01
影响因子：
5.8
通讯作者：
Mader, Julia K.
中科院分区：
文献类型：
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作者：
Aberer, Felix;Hajnsek, Martin;Mader, Julia K.
在糖尿病治疗中已经建立了连续和快速血糖监测(GM)系统。我们比较了3种商用转基因系统的传感器性能。共有12名1型糖尿病患者参加了一项单中心、开放标签的研究，比较雅培Freestyle libre(雅培)、Dexcom G4白金(Dexcom)和美敦力MiniMed 640G(美敦力)系统在模拟现实生活条件下(饮食、运动、低血糖和高血糖)12小时内的传感器性能。传感器的性能是通过满足国际标准化组织15197：2013年标准，计算平均绝对相对差来确定的，并使用帕克斯误差网格和布兰德-阿尔特曼曲线图进行了说明。传感器在代谢变量(乳酸、β-羟基丁酸盐、高血糖素、非酯化脂肪酸)变化时的性能通过Spearman等级相关系数检验来确定。这些系统符合ISO 15197：2013年标准的比例分别为73.2%(雅培)、56.1%(德克斯康)和52.0%(美敦力)。在整个血糖范围内，MARDS+/-标准偏差分别为13.2%+/-10.9%(雅培)、16.8%+/-12.3%(Dexcom)和21.4%+/-17.6%(美敦力)。所有传感器在低血糖时表现较差，而在高血糖时表现最佳。我们没有观察到代谢变量对传感器性能的影响。
Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo-and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197: 2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland-Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non-esterified-fatty-acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197: 2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs +/- standard deviation in the entire glycaemic range were 13.2% +/- 10.9% (Abbott), 16.8% +/- 12.3% (Dexcom) and 21.4% +/- 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.