Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions.
Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions.
复制标题
自由生活条件下三项闭环家庭研究期间连续血糖监测的准确性。
DOI：
10.1089/dia.2015.0062
复制
发表时间：
2015
影响因子：
5.4
通讯作者：
Arnolds
中科院分区：
文献类型：
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作者：
Thabit,Hood;Leelarathna,Lalantha;Wilinska,MalgorzataE;Elleri,Daniella;Allen,JanetM;Lubina-Solomon,Alexandra;Walkinshaw,Emma;Stadler,Marietta;Choudhary,Pratik;Mader,JuliaK;Dellweg,Sibylle;Benesch,Carsten;Pieber,ThomasR;Arnolds
目的：闭环（CL）系统根据动态血糖监测仪（CGM）测量的血糖水平调节胰岛素输注。CGM的准确性影响CL性能和安全性。我们评估了Freestyle Navigator®II CGM的准确性（Abbott Diabetes Care，阿拉米达，CA）在三项无监督、随机、开放标签、交叉家庭CL研究期间进行。从57名1型糖尿病患者中收集了10，597对（在5个中心招募了41名成人[平均±SD年龄，39±12岁;平均±SD血红蛋白A1 c，7.9±0.8%]和16名青少年[平均±SD年龄，15.6±3.6岁;平均值±SD血红蛋白A1 c，8.1±0.8%]，在两个中心招募）。通过绝对相对差（ARD）和国际标准化组织（ISO）15197：2013 15/15%限值评估数值准确度，通过Clarke误差网格分析评估临床准确度。毛细血管葡萄糖范围（1.1-27.8 mmol/L）的总体探头准确度显示平均值±SD和中位数（四分位距）ARD分别为14.2±15.5%和10.0%（4.5%，18.4%）。在高血糖范围内观察到最低平均ARD（9.8±8.8%）。超过95%的对位于组合Clarke误差网格区域A和B中（A，80.1%，B，16.2%）。总体而言，70.0%的传感器读数符合ISO标准。平均ARD是一致的（12.3%; 95%的值落在±3.7%），并没有不同的参与者（P=0.06）之间的血糖正常和高血糖范围内，CL是积极调节insulin delivery.Conclusions：一致的准确性CGM血糖正常-高血糖范围内使用自由式Navigator II观察，并支持其使用在家庭CL研究。我们的研究结果可能有助于建立规范的CGM性能标准，无监督的家庭使用CL。
Objectives:Closed-loop (CL) systems modulate insulin delivery based on glucose levels measured by a continuous glucose monitor (CGM). Accuracy of the CGM affects CL performance and safety. We evaluated the accuracy of the Freestyle Navigator®II CGM (Abbott Diabetes Care, Alameda, CA) during three unsupervised, randomized, open-label, crossover home CL studies.Materials and Methods:Paired CGM and capillary glucose values (10,597 pairs) were collected from 57 participants with type 1 diabetes (41 adults [mean±SD age, 39±12 years; mean±SD hemoglobin A1c, 7.9±0.8%] recruited at five centers and 16 adolescents [mean±SD age, 15.6±3.6 years; mean±SD hemoglobin A1c, 8.1±0.8%] recruited at two centers). Numerical accuracy was assessed by absolute relative difference (ARD) and International Organization for Standardization (ISO) 15197:2013 15/15% limits, and clinical accuracy was assessed by Clarke error grid analysis.Results:Total duration of sensor use was 2,002 days (48,052 h). Overall sensor accuracy for the capillary glucose range (1.1–27.8 mmol/L) showed mean±SD and median (interquartile range) ARD of 14.2±15.5% and 10.0% (4.5%, 18.4%), respectively. Lowest mean ARD was observed in the hyperglycemic range (9.8±8.8%). Over 95% of pairs were in combined Clarke error grid Zones A and B (A, 80.1%, B, 16.2%). Overall, 70.0% of the sensor readings satisfied ISO criteria. Mean ARD was consistent (12.3%; 95% of the values fall within ±3.7%) and not different between participants (P=0.06) within the euglycemic and hyperglycemic range, when CL is actively modulating insulin delivery.Conclusions:Consistent accuracy of the CGM within the euglycemic–hyperglycemic range using the Freestyle Navigator II was observed and supports its use in home CL studies. Our results may contribute toward establishing normative CGM performance criteria for unsupervised home use of CL.