Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taiwan; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Post-Baccalaureate Medicine, College of Medicine, National Chung University.
Department of Pathology and Laboratory Medicine, Taichung Veterans General Hospital, Taiwan.
Clin Ther. 2023 Jul;45(7):643-648. doi: 10.1016/j.clinthera.2023.05.005. Epub 2023 May 27.
Inpatient glycemic management has become a common issue because of the increasing number of hospitalized patients with hyperglycemia. Point-of-care devices can enable timely inpatient glucose monitoring, which may lead to better outcomes. The accuracy of point-of-care testing in various clinical scenarios has been questioned, particularly in neonates and critically ill patients. This study aimed to evaluate the accuracy of the CONTOUR PLUS and CONTOUR PLUS ONE glucometers (new wireless systems that link to a smart mobile device) when used as point-of-care devices for blood glucose monitoring in neonates and critically ill adults in inpatient settings.
This cross-sectional study was conducted at a medical center in central Taiwan and enrolled patients admitted to the neonatal intensive care unit, sick child room, or respiratory intensive care unit between November 2020 and April 2021. Neonates with suspected infection or abnormal blood coagulation and adults who had abnormal blood coagulation, were pregnant, had received organ transplants, or had undergone massive blood transfusions were excluded. The accuracy of the glucometers was determined based on the following criteria of the International Organization for Standardization (ISO) standard: 15197:2013.
Overall, 114 neonates (mean age, 4.2 days [range, 0-28 days]; 65 boys [57.0%]) and 106 hospitalized critically ill adults (mean age, 68.2 years [range, 27-94 years]; 72 men [67.9%]) were enrolled in this study. The glucose values obtained with each glucometer had good precision, and all findings met the reference criteria of the within-lot results. All measurements of the neonates' venous blood by each glucometer met the accuracy criteria specified by ISO standard 15197:2013. Furthermore, 98.1% and 97.2% of the arterial blood glucose measurements for critically ill adults obtained with CONTOUR PLUS and CONTOUR PLUS ONE met the accuracy criteria, respectively.
Both glucose management systems met the accuracy criteria for venous blood from neonates and arterial blood from critically ill adults. Thus, the use of these 2 point-of-care devices in inpatient settings, including for neonates and critically ill adults, can be recommended to minimize limitations associated with the clinical application of point-of-care testing in glucose management. The wireless connection may play a role in the subsequent development of institution-wide virtual glycemic management under the supervision of a team of endocrinologists.
由于住院高血糖患者数量的增加，住院患者的血糖管理已成为一个常见问题。即时检测设备可实现及时的住院血糖监测，从而可能改善治疗结局。即时检测在各种临床情况下的准确性受到质疑，尤其是在新生儿和重症患者中。本研究旨在评估 CONTOUR PLUS 和 CONTOUR PLUS ONE 血糖仪（新的无线系统，可与智能移动设备连接）在住院环境中作为新生儿和重症成人的即时检测设备进行血糖监测时的准确性。
本横断面研究在台湾中部的一家医疗中心进行，纳入 2020 年 11 月至 2021 年 4 月期间入住新生儿重症监护病房、小儿科病房或呼吸重症监护病房的患者。排除疑似感染或凝血异常的新生儿以及凝血异常、妊娠、接受器官移植或大量输血的成人。血糖仪的准确性根据国际标准化组织（ISO）标准 15197:2013 的以下标准确定：
精密度
准确性
本研究共纳入 114 例新生儿（平均年龄 4.2 天[范围 0-28 天]；65 名男性[57.0%]）和 106 例住院重症成人（平均年龄 68.2 岁[范围 27-94 岁]；72 名男性[67.9%]）。两种血糖仪获得的血糖值具有良好的精密度，所有结果均符合批内结果的参考标准。两种血糖仪对新生儿静脉血的所有测量值均符合 ISO 标准 15197:2013 规定的准确性标准。此外，CONTOUR PLUS 和 CONTOUR PLUS ONE 对重症成人的动脉血糖测量值中，分别有 98.1%和 97.2%符合准确性标准。
两种血糖管理系统均符合新生儿静脉血和重症成人动脉血的准确性标准。因此，建议在住院环境中使用这两种即时检测设备，包括用于新生儿和重症成人，以尽量减少即时检测在血糖管理中的临床应用所带来的局限性。无线连接可能在团队监管下的全院虚拟血糖管理的后续发展中发挥作用。
