用于连续血糖读数的经皮询问式基于荧光寿命的微传感器的临床评估。
Clinical evaluation of a transcutaneous interrogated fluorescence lifetime-based microsensor for continuous glucose reading.
作者信息
Nielsen Jannik K, Christiansen Jens S, Kristensen Jesper S, Toft Hans O, Hansen Lars Lundby, Aasmul Søren, Gregorius Klaus
机构信息
Department of Diabetes and Endocrinology, Aarhus University Hospital, Aarhus C, Denmark.
出版信息
J Diabetes Sci Technol. 2009 Jan;3(1):98-109. doi: 10.1177/193229680900300111.
BACKGROUND
Continuous glucose monitoring is presently used worldwide. Accuracy, precision, durability, invasiveness, and lack of drift of sensors and lag time are key parameters essential to these systems. This article describes a new online minimally invasive biodegradable microsensor for optical, transcutaneous interrogation, which has at least 14 days of functionality.
METHOD
Studies were performed in vitro and in vivo on pigs, as well as on type 1 diabetic humans. Functionality has been ensured in laboratory settings, and precision and durability have been tested in vivo. During in vivo studies, venous blood samples were used as reference. Results were based on one single point calibration per experiment.
RESULTS
Excellent stability was found in 14-day in vitro trials as well as in vivo in up to 70-hour trials. The overall median relative absolute difference of type 1 diabetic patients was 11.4%. Error grid analysis showed 97.7% of all values in the A+B zone. Comparable results were found in animal studies. No sensor drift was observed in any trial.
CONCLUSION
Results point toward the possibility of developing a stable and precise minimally invasive glucose reader for at least 2 weeks of continuous use.
背景
目前，连续血糖监测在全球范围内得到应用。传感器的准确性、精密度、耐用性、侵入性、无漂移性以及滞后时间是这些系统的关键参数。本文介绍了一种新型的在线微创可生物降解微传感器，用于光学经皮检测，其功能至少持续14天。
方法
在猪以及1型糖尿病患者身上进行了体外和体内研究。在实验室环境中确保了功能，并在体内测试了精密度和耐用性。在体内研究期间，使用静脉血样本作为参考。结果基于每个实验的单点校准。
结果
在为期14天的体外试验以及长达70小时的体内试验中均发现了出色的稳定性。1型糖尿病患者的总体中位相对绝对差异为11.4%。误差网格分析显示，所有值中有97.7%位于A+B区。在动物研究中也发现了类似结果。在任何试验中均未观察到传感器漂移。
结论
结果表明，有可能开发出一种稳定且精确的微创血糖读取器，可连续使用至少2周。
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