介电光谱无创连续血糖监测

J. Burd
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引用次数: 2

摘要

Alertgy无创连续血糖监测仪(NICBGM)是一种新型腕带设备,可以在不需要任何皮肤穿刺的情况下报告血糖水平。这项研究评估了该设备与美国食品药品监督管理局批准的2型糖尿病患者血糖仪的性能。方法:Alertgy DeepGluco NICBGM设备每分钟三次测量其收集的特定于血糖水平的介电光谱的变化。该光谱数据通过使用神经网络分析、机器学习进行分析,然后通过校准过程生成算法,以在系统校准到个人后估计血糖(BG)值。使用Roche Accuchek Inform II血糖仪作为校准的参考技术,然后确定血糖测定的准确性。27名患者完成了三次或三次以上120分钟的疗程。根据收集的数据计算平均绝对相对差(MARD)。结果:MARD值是在第一天校准后的两天或两天以上的数据收集中汇编的。所有测量的MARD为15.3。结论:由此产生的MARD表明,当使用相同的参考技术时,该技术可以实现与美国食品药品监督管理局目前批准的现有CGM设备相同的性能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Noninvasive Continuous Blood Glucose Monitoring by Dielectric Spectroscopy
The Alertgy noninvasive continuous blood glucose monitor (NICBGM) is a novel wristband device that reports glucose levels without any entailing skin puncture. This study evaluated the performance of this device compared with an FDA-approved glucose meter in patients with type 2 diabetes. Methods: The Alertgy DeepGluco NICBGM device measures changes in the dielectric spectrum it collects specific to blood glucose levels three times a minute. This spectral data is analyzed by using neural network analysis, machine learning and then with a calibration process is used to generate algorithms to estimate blood glucose (BG) values once the system is calibrated to the individual. The Roche Accuchek Inform II glucometer was used as a reference technique for calibration and then to determine the accuracy of blood glucose determinations. 27 patients completed three or more 120-minute sessions. Mean absolute relative difference (MARD) was calculated on the data collected. Results: MARD values were compiled for two or more days of data collection following the first day of calibration. The MARD for all measurements was found to be 15.3. Conclusions: The resultant MARD suggest that this technique can achieve equivalent performance to that of existing CGM devices presently approved by the FDA when the same reference technique is utilized.
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