Design, development, and evaluation of a novel microneedle array-based continuous glucose monitor.
Design, development, and evaluation of a novel microneedle array-based continuous glucose monitor.
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DOI：
10.1177/1932296814526191
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发表时间：
2014-05-01
影响因子：
5
通讯作者：
Christiansen, Mark
中科院分区：
文献类型：
--
作者：
Jina, Arvind;Tierney, Michael J;Christiansen, Mark
几个小组一直致力于开发准确、微创的连续血糖监测(CGM)设备，因为人们相信，侵入性更小、用户更友好的设备将导致胰岛素依赖型糖尿病患者更多地采用CGM。本文介绍了一种新型微针连续血糖监测仪在糖尿病患者中的初步临床研究结果。在该装置中，一组微小的中空微针被应用到表皮中，间质液中的葡萄糖通过被动扩散被输送到体外的电流型葡萄糖传感器。对10名糖尿病受试者长达72小时佩戴的1396对血糖测量设备和手指血糖读数进行了比较，结果表明该设备准确，受试者对该设备的耐受性良好。总体平均绝对相对差异(MARD)为15%，其中98.4%的配对点位于Clarke误差网格的A+B区域。该原型设备已经在72小时内展示了临床上准确的血糖读数，这是基于微针的设备首次实现这样的性能。
The development of accurate, minimally invasive continuous glucose monitoring (CGM) devices has been the subject of much work by several groups, as it is believed that a less invasive and more user-friendly device will result in greater adoption of CGM by persons with insulin-dependent diabetes. This article presents the results of preliminary clinical studies in subjects with diabetes of a novel prototype microneedle-based continuous glucose monitor. In this device, an array of tiny hollow microneedles is applied into the epidermis from where glucose in interstitial fluid (ISF) is transported via passive diffusion to an amperometric glucose sensor external to the body. Comparison of 1396 paired device glucose measurements and fingerstick blood glucose readings for up to 72-hour wear in 10 diabetic subjects shows the device to be accurate and well tolerated by the subjects. Overall mean absolute relative difference (MARD) is 15% with 98.4% of paired points in the A+B region of the Clarke error grid. The prototype device has demonstrated clinically accurate glucose readings over 72 hours, the first time a microneedle-based device has achieved such performance.