Noninvasive Spectroscopic Sensors for Glucose and Urea

描述(由申请人提供)：提出了一项研究计划，以促进无创传感技术的发展，用于在人体内测量血糖和尿素。建议的方法是将特定的近红外线光带穿过身体上选定的测量位置，然后从产生的非侵入性光谱中提取所需的分析信息。我们以前的工作结果表明，1)组合光谱区在区分复杂生物基质中的葡萄糖方面优于所有其他近红外光谱区，2)光谱质量是关键的，几个微吸收单位(PAU)的均方根噪声水平是必要的，3)足够的样品厚度才能为分析提供可区分的吸收信号。所有这些要求都在拟议的研究计划中得到了满足。将使用定制的傅里叶变换近红外光谱仪，通过噪声级别为2PAU的人体组织提供高质量的组合光谱。提出了一种光纤接口，用于通过手背或鼻中隔软骨上的一小撮皮肤收集非侵入性光谱。每个假定的测量位置都具有成功测量葡萄糖和尿素所需的适当厚度和化学成分。第一次，我们同时拥有了仪器和推定的测量地点，与组合光谱的非侵入性测量兼容。对该系统进行了一系列的体外实验，以确定该系统对葡萄糖和尿素的检测能力，检测限分别为2 mm和1.5 mm。这两个测量点的动物模型也已经确定，并将被用于严格建立这种方法的分析效用。最后，建议进行人体受试性实验，以获得有关人体体内环境的关键信息，并评估葡萄糖和尿素的实际体内测量。成功将从糖尿病和终末期肾脏疾病的治疗和管理的改善中带来巨大的医疗保健好处。

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.