SBIR Phase I: An Optically-Efficient Miniaturized Raman Optical System for Trending Glucose Levels

该小型企业创新研究计划第一阶段项目提出开发一种手持式拉曼光学系统，用于无创、连续和实时监测血糖水平。 拉曼光谱学使用被化学物质散射的激光来基于在它们的光学指纹中发现的移位光谱来区分、识别和量化它们。 葡萄糖的指纹可用于键入和记录其在生物组织中（例如在间质液和血液中）随时间的浓度变化。 该项目的目标是将现有的拉曼台式系统升级为可穿戴、低成本且针对糖尿病患者的血糖测量进行优化的系统。 因为这种方法是无创的，所以它有可能限制为血糖测量而抽血所需的每日多次手指穿刺测量，并避免与需要导管插入物的现有商业连续血糖监测仪相关的生物污染问题。 因为它可以连续测量，测量可以提供曲线数据，而不是从每个手指刺静态单次测量。 从这些数据中获得的葡萄糖动力学可以用来建立一个更好的血糖控制方案，结合更好的饮食和改善胰岛素剂量。该项目的更广泛的影响/商业潜力是帮助改善2600万美国糖尿病患者的生活，血糖控制是他们健康的核心。 疾病控制中心（CDC）预测，到2050年，三分之一的美国人（近1.5亿人）将患有糖尿病。 美国糖尿病协会（ADA）和CDC也估计，美国糖尿病的直接和间接成本每年为1080亿至1740亿美元。 这些成本可以通过更好的护理管理来显著降低，其中可获得性和采用更新的，具有成本效益的，易于集成和易于使用的技术可以减少直接成本，预防性警告可以减少间接成本。 如果该项目的小型化推进成功，手持平台可以处理多种血液分析物，包括酮、乳酸盐、尿素、胆固醇、血细胞比容和酒精。 例如，执法部门可以在现场使用它来检测血液中的非法物质。 小型化还使移动的自我诊断和患者依从性成为可能，这是两个巨大的新兴市场。 将诊断数据远程和实时传递给临床医生进行分析以预示医疗紧急情况的能力将是革命性的。

This Small Business Innovation Research Program Phase I project proposes to develop a handheld Raman optical system for monitoring blood glucose levels noninvasively, continuously, and in real-time. Raman spectroscopy uses laser light scattered by chemical species to distinguish, identify, and quantify them based on the shifted spectrum found in their optical fingerprint. The fingerprint of glucose can be used to key in and register its changes in concentration over time in biological tissues, such as in the interstitial fluid and in the blood. The objectives of this project are to miniaturize an existing Raman bench-top system to one that is wearable, low-cost, and optimized for blood glucose measurement in diabetic patients. Because this approach is noninvasive, it has the potential to limit the multiple-daily finger prick measurements required to draw blood for glucose measurement, and obviates biofouling issues associated with existing commercial continuous glucose monitors that require catheter inserts. Because it can measure continuously, measurements can provide curve data instead of static single-shot measurements from each finger prick. Glucose dynamics obtained from this data can then be used to establish a better regimen for glucose control with a combination of better diets and improved insulin dosage.The broader impact/commercial potential of this project is to help improve the lives of 26 million American diabetics where blood glucose control is central to their health. The Center for Disease Control (CDC) predicts one out three Americans (almost 150 million) will be diabetic by 2050. The American Diabetes Association (ADA) and CDC also estimate the existing cost in the United States of diabetes, direct and indirect, to be $108B ~ $174B annually. These costs can be significantly mitigated with better management of care, where accessibility and adoption of newer, cost-effective, easy-to-integrate, and easy-to-use technologies can reduce direct costs, and where preventative warnings could reduce indirect costs. If this program's miniaturization thrust succeeds, there are multiple blood analytes that a handheld platform could address, including ketones, lactates, urea, cholesterol, hematocrit, and alcohol. As an example, law enforcement could use it in the field to detect illegal substances in the bloodstream. Miniaturization also enables mobile self-diagnostics and patient compliance, two enormous emerging markets. The ability to relay diagnostic data to clinicians remotely and in real-time for analysis to portend medical emergencies would be revolutionary.