临床研究使用创新光学传输吸收系统的高精度绿色设计血糖仪。
Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.
机构信息
Terumo Corporation, Yamanashi, Japan.
Joint Department of Biomedical Engineering, The University of North Carolina at Chapel Hill and North Carolina State University, Chapel Hill, NC, USA.
出版信息
J Diabetes Sci Technol. 2022 Sep;16(5):1069-1075. doi: 10.1177/19322968211060865. Epub 2021 Dec 10.
BACKGROUND
Blood glucose monitoring (BGM) is essential for glycemic control in diabetic therapy. Followingly, accurate sensors are required for both daily personal and clinical use. The frequency of sensor use in patients with diabetes facilitates the use of disposable components. However, BGM systems are not exempt from green innovation sustainability initiatives.
METHODS
Clinical study of a high-accuracy green design blood glucose monitor using an innovative optical transmission absorbance system was carried out. Venous blood samples were collected from 104 patients with type II diabetes. The heat resistance of sensor strips was evaluated by storing sensor strips at 25℃ and 60℃ for approximately 3 months. Accuracy of the BGM system was evaluated via the ISO 15197:2013 protocol.
RESULTS
The BGM system achieved ±7.1% accuracy in glycemic level measurement, with 84% of all measurements within ±5% of the reference values. Furthermore, the sensor strip demonstrated heat resistance for more than 3 months when stored at 60℃.
CONCLUSIONS
A new, highly accurate BGM system was developed based on the latest optical measurement system, introducing a rare metal-free "green-strip." The developed BGM system achieved the highest reported accuracy in clinical research, using venous blood from patients with diabetes. The sensor strip also exhibited high heat resistance, reducing limitations on storage conditions.
背景
血糖监测（BGM）对于糖尿病治疗中的血糖控制至关重要。因此，无论是日常个人使用还是临床使用，都需要精确的传感器。糖尿病患者频繁使用传感器有助于使用一次性组件。然而，BGM 系统也不能免除绿色创新可持续性计划。
方法
对使用创新光学传输吸收系统的高精度绿色设计血糖仪进行了临床研究。从 104 名 2 型糖尿病患者中采集静脉血样本。通过将传感器条储存在 25℃和 60℃下约 3 个月来评估传感器条的耐热性。通过 ISO 15197:2013 协议评估 BGM 系统的准确性。
结果
BGM 系统在血糖水平测量方面的准确度达到±7.1%，所有测量值中有 84%在参考值的±5%以内。此外，当储存在 60℃时，传感器条的耐热性超过 3 个月。
结论
基于最新的光学测量系统，开发了一种新的、高度精确的 BGM 系统，引入了一种不含稀有金属的“绿色条”。所开发的 BGM 系统在使用糖尿病患者静脉血的临床研究中达到了最高的准确性报告。传感器条还表现出很高的耐热性，降低了对储存条件的限制。
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