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

这个小型企业创新研究计划第一阶段项目建议开发一种手持拉曼光学系统，用于非侵入性、连续和实时监测血糖水平。拉曼光谱使用由化学物种散射的激光，根据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。葡萄糖的指纹可以用来输入和记录其在生物组织中随时间的浓度变化，例如在间质液体和血液中。该项目的目标是将现有的拉曼台式系统小型化，使其成为可穿戴、低成本并优化的糖尿病患者血糖测量系统。由于这种方法是非侵入性的，它有可能限制每日多次抽血进行血糖测量所需的手指刺伤测量，并避免与现有的需要插入导管的商用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，所以测量可以提供曲线数据，而不是每个指尖的静态单次测量。从这些数据中获得的血糖动态可以用来建立一种更好的血糖控制方案，将更好的饮食和更好的胰岛素剂量结合起来。这个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，因为血糖控制对他们的健康至关重要。疾病控制中心(CDC)预测，到2050年，三分之一的美国人(近1.5亿)将患有糖尿病。美国糖尿病协会(ADA)和美国疾病控制与预防中心(CDC)也估计，美国现有的糖尿病直接和间接成本为每年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，在这种情况下，获取和采用更新、具有成本效益、易于整合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。如果这个项目的小型化推进成功，手持平台可以处理多种血液分析，包括酮、乳酸、尿素、胆固醇、红细胞压积和酒精。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。小型化还使移动自我诊断和患者合规成为可能，这是两个巨大的新兴市场。将诊断数据远程和实时地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.