Wolde Mistire, Tarekegn Getahun, Kebede Tedla
1 Department of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
2 Department of Internal Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
J Diabetes Sci Technol. 2018 May;12(3):673-679. doi: 10.1177/1932296817751747. Epub 2018 Jan 17.
Point-of-care glucometer (PoCG) devices play a significant role in self-monitoring of the blood sugar level, particularly in the follow-up of high blood sugar therapeutic response. The aim of this study was to evaluate blood glucose test results performed with four randomly selected glucometers on diabetes and control subjects versus standard wet chemistry (hexokinase) methods in Addis Ababa, Ethiopia.
A prospective cross-sectional study was conducted on randomly selected 200 study participants (100 participants with diabetes and 100 healthy controls). Four randomly selected PoCG devices (CareSens N, DIAVUE Prudential, On Call Extra, i-QARE DS-W) were evaluated against hexokinase method and ISO 15197:2003 and ISO 15197:2013 standards.
The minimum and maximum blood sugar values were recorded by CareSens N (21 mg/dl) and hexokinase method (498.8 mg/dl), respectively. The mean sugar values of all PoCG devices except On Call Extra showed significant differences compared with the reference hexokinase method. Meanwhile, all four PoCG devices had strong positive relationship (>80%) with the reference method (hexokinase). On the other hand, none of the four PoCG devices fulfilled the minimum accuracy measurement set by ISO 15197:2003 and ISO 15197:2013 standards. In addition, the linear regression analysis revealed that all four selected PoCG overestimated the glucose concentrations.
The overall evaluation of the selected four PoCG measurements were poorly correlated with standard reference method. Therefore, before introducing PoCG devices to the market, there should be a standardized evaluation platform for validation. Further similar large-scale studies on other PoCG devices also need to be undertaken.
即时血糖仪（PoCG）在血糖水平的自我监测中发挥着重要作用，尤其是在高血糖治疗反应的随访中。本研究的目的是在埃塞俄比亚亚的斯亚贝巴，比较四种随机选择的血糖仪对糖尿病患者和对照受试者进行血糖检测的结果与标准湿化学（己糖激酶）方法的结果。
对随机选择的200名研究参与者（100名糖尿病患者和100名健康对照）进行了一项前瞻性横断面研究。将四种随机选择的PoCG设备（CareSens N、DIAVUE Prudential、On Call Extra、i-QARE DS-W）与己糖激酶法以及ISO 15197:2003和ISO 15197:2013标准进行评估。
CareSens N记录的血糖最小值为21mg/dl，己糖激酶法记录的血糖最大值为498.8mg/dl。除On Call Extra外，所有PoCG设备的平均血糖值与参考己糖激酶法相比均有显著差异。同时，所有四种PoCG设备与参考方法（己糖激酶法）均有很强的正相关关系（>80%）。另一方面，四种PoCG设备均未达到ISO 15197:2003和ISO 15197:2013标准设定的最低准确度测量要求。此外，线性回归分析显示，所有四种选定的PoCG设备都高估了葡萄糖浓度。
所选四种PoCG测量的总体评估与标准参考方法的相关性较差。因此，在将PoCG设备推向市场之前，应该有一个标准化的评估平台进行验证。还需要对其他PoCG设备开展进一步类似的大规模研究。
