Noninvasive Spectroscopic Sensors for Glucose and Urea

项目描述（由申请人提供）：提出一项研究计划，旨在推进人体受试者体内葡萄糖和尿素测量的无创传感技术的发展。提出的方法是将特定波段的近红外光通过选定的身体测量部位，然后从产生的非侵入性光谱中提取所需的分析信息。我们之前的工作结果表明：1)组合光谱区优于所有其他近红外光谱区，用于区分复杂生物基质中的葡萄糖；2)光谱质量至关重要，几个微吸光度单元（pAU）的rms噪声水平是必要的；3)需要足够的样品厚度来提供可区分的吸光度信号。这些要求都在拟议的研究计划中得到满足。定制的傅里叶变换近红外光谱仪将用于提供高质量的组合光谱，通过人体组织，噪声水平约为2pau。提出了一种光纤接口，通过捏捏手背上的皮肤或鼻子的鼻中隔软骨来收集无创光谱。每个假定的测量位点都具有适当的厚度和化学成分，可以成功地测量葡萄糖和尿素。这是第一次，我们有仪器和假定的测量点，是兼容的无创测量与组合光谱。提出了一系列的体外实验来表征该系统测量葡萄糖和尿素的能力，检测限分别为2和1.5 mM。动物模型也已被确定为两个测量地点，并将用于严格建立这种方法的分析效用。最后，提出了人体实验，以获得有关人体体内环境的关键信息，并评估实际体内葡萄糖和尿素的测量值。成功将提供巨大的医疗效益，从改善治疗和管理糖尿病和终末期肾脏疾病。

DESCRIPTION (provided by applicant): A research plan is proposed to advance the development of noninvasive sensing technology for the in vivo measurement of glucose and urea in human subjects. The proposed approach is to pass a specific band of near-infrared light through a selected measurement site on the body and then extract the desired analytical information from the resulting noninvasive spectrum. Results from our previous work demonstrate that 1) the combination spectral region is superior to all other near-infrared spectral regions for distinguishing glucose in complex biological matrices, 2) spectral quality is critical and RMS-noise levels of several micro-absorbance units (pAU) are necessary, and 3) sufficient sample thickness is required to provide distinguishable absorbance signals for analysis. Each of these requirements is satisfied in the proposed research plan. A customized Fourier transform near infrared spectrometer will be used to provide high quality combination spectra through human tissue with noise levels on the order of 2 pAU. A fiber-optic interface is proposed for collecting noninvasive spectra through a pinch of skin on the back of the hand or the septal cartilage of the nose. Each of these putative measurement sites possesses the appropriate thickness and chemical composition for successful glucose and urea measurements. For the first time, we have both the instrumentation and putative measurement sites that are compatible with noninvasive measurements with combination spectra. A series of in vitro experiments are proposed to characterize this system for the ability to measure glucose and urea with limits of detection of 2 and 1.5 mM, respectively. Animal models have also been identified for both measurement sites and will be used to rigorously establish the analytical utility of this approach. Finally, human subject experiments are proposed to obtain critical information about the human in vivo environment and to evaluate actual in vivo measurements of glucose and urea. Success will provide tremendous healthcare benefits arising from an improvement in the treatment and management of diabetes and end stage renal disease.