DeSalvo Daniel J, Shanmugham Satya, Ly Trang T, Wilson Darrell M, Buckingham Bruce A
Stanford University School of Medicine, Stanford, CA, USA.
Stanford University School of Medicine, Stanford, CA, USA
J Diabetes Sci Technol. 2014 Sep;8(5):969-73. doi: 10.1177/1932296814532238. Epub 2014 May 21.
This pilot study evaluated the difference in accuracy between the Bayer Contour® Next (CN) and HemoCue® (HC) glucose monitoring systems in children with type 1 diabetes participating in overnight closed-loop studies. Subjects aged 10-18 years old were admitted to a clinical research center and glucose values were obtained every 30 minutes overnight. Glucose values were measured using whole blood samples for CN and HC readings and results were compared to Yellow Springs Instrument (YSI) reference values obtained with plasma from the same sample. System accuracy was compared using mean absolute relative difference (MARD) and International Organization for Standardization (ISO) accuracy standards. A total of 28 subjects were enrolled in the study. Glucose measurements were evaluated at 457 time points. CN performed better than HC with an average MARD of 3.13% compared to 10.73% for HC (P < .001). With a limited sample size, CN met ISO criteria (2003 and 2013) at all glucose ranges while HC did not. CN performed very well, and would make an excellent meter for future closed-loop studies outside of a research center.
这项初步研究评估了拜耳轮廓Next(CN)和海莫克(HC)血糖监测系统在参与夜间闭环研究的1型糖尿病儿童中准确性的差异。10至18岁的受试者被收治到临床研究中心,夜间每30分钟获取一次血糖值。使用全血样本测量CN和HC的读数血糖值,并将结果与从同一样本血浆中获得的黄泉仪器(YSI)参考值进行比较。使用平均绝对相对差异(MARD)和国际标准化组织(ISO)准确性标准比较系统准确性。共有28名受试者参与了该研究。在457个时间点评估血糖测量值。CN的表现优于HC,平均MARD为3.13%,而HC为10.73%(P <.001)。在样本量有限的情况下,CN在所有血糖范围内均符合ISO标准(2003年和2013年),而HC则不符合。CN表现非常出色,将成为未来研究中心以外闭环研究的优秀血糖仪。