Noninvasive Spectroscopic Sensors for Glucose and Urea

描述（由申请人提供）：提出了一项研究计划，以推进用于人体葡萄糖和尿素体内测量的无创传感技术的开发。所提出的方法是将特定波段的近红外光通过身体上选定的测量部位，然后从所产生的非侵入性光谱中提取所需的分析信息。从我们以前的工作结果表明，1）组合光谱区是上级的所有其他近红外光谱区区分葡萄糖在复杂的生物基质，2）光谱质量是至关重要的，RMS噪声水平的几个微吸光度单位（pAU）是必要的，和3）足够的样品厚度，需要提供可区分的吸光度信号进行分析。这些要求中的每一个都在拟议的研究计划中得到满足。将使用定制的傅里叶变换近红外光谱仪提供通过人体组织的高质量组合光谱，噪声水平约为2 pAU。提出了一种光纤接口，用于通过手背上的皮肤或鼻子的中隔软骨的捏收集非侵入性光谱。这些假定的测量位点中的每一个都具有用于成功的葡萄糖和尿素测量的适当厚度和化学组成。这是第一次，我们既有仪器和假定的测量网站，是兼容的非侵入性测量与组合光谱。提出了一系列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。还确定了两个测量部位的动物模型，并将用于严格建立这种方法的分析实用性。最后，人类受试者的实验，提出了获得关键信息的人在体内环境，并评估实际的体内测量葡萄糖和尿素。成功将提供巨大的医疗保健效益，改善糖尿病和终末期肾病的治疗和管理。

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.