Chien Ming-Nan, Chen Yu-Jen, Bai Chin-Han, Huang Jung-Tung
Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital and Mackay Medical College, National Taipei University of Technology, No. 1, Sec. 3, Zhongxiao E. Rd. Da'an Dist., Taipei City 106, Taiwan.
National Taipei University of Technology, No. 1, Sec. 3, Zhongxiao E. Rd. Da'an Dist., Taipei City 106, Taiwan.
Micromachines (Basel). 2022 Mar 20;13(3):478. doi: 10.3390/mi13030478.
A continuous blood glucose monitoring system (CGMS) which include a microneedle-array blood glucose sensor, a circuit module, and a transmission module placed in a wearable device is developed in this research. When in use, the wearable device is attached to the human body with the microneedle array inserted under the skin for continuous blood glucose sensing, and the measured signals are transmitted wirelessly to a mobile phone or computer for analysis. The purpose of this study is to replace the conventionally used method of puncture for blood collection and test strips are used to measure the blood glucose signals. The microneedle sensor of this CGMS uses a 1 mm length needle in a 3 mm × 3 mm microneedle array for percutaneous minimally invasive blood glucose measurement. This size of microneedle does not cause bleeding damage to the body when used. The microneedle sensor is placed under the skin and their solutions are discussed. The blood glucose sensor measured the in vitro simulant fluid with a glucose concentration range of 50~400 mg/dL. In addition, a micro-transfer method is developed to accurately deposit the enzyme onto the tip of the microneedle, after which cyclic voltammetry (CV) is used to measure the glucose simulation solution to verify whether the difference in the amount of enzyme on each microneedle is less than 10%. Finally, various experiments and analyses are carried out to reduce the size of the device, test effective durability (approximately 7 days), and the feasibility of minimally invasive CGMS is evaluated by tests on two persons.
本研究开发了一种连续血糖监测系统（CGMS），该系统包括置于可穿戴设备中的微针阵列血糖传感器、电路模块和传输模块。使用时，可穿戴设备附着于人体，微针阵列插入皮下进行连续血糖传感，测量信号无线传输至手机或计算机进行分析。本研究的目的是取代传统的采血穿刺方法，使用测试条来测量血糖信号。该CGMS的微针传感器在3mm×3mm的微针阵列中使用1mm长的针进行经皮微创血糖测量。这种尺寸的微针在使用时不会对身体造成出血损伤。讨论了微针传感器置于皮下的情况及其解决方案。血糖传感器测量了葡萄糖浓度范围为50~400mg/dL的体外模拟液。此外，还开发了一种微转移方法，将酶精确地沉积在微针尖端，然后使用循环伏安法（CV）测量葡萄糖模拟溶液，以验证每根微针上酶量的差异是否小于10%。最后，进行了各种实验和分析以减小设备尺寸、测试有效耐用性（约7天），并通过对两人的测试评估微创CGMS的可行性。
