SBIR Phase II: A Miniaturized Raman Optical System for Trending Glucose Levels

SBIR 第二阶段：用于监测血糖水平趋势的小型化拉曼光学系统

• 批准号: 1431032
• 负责人: Raj Gupta
• 金额: $ 75万
• 依托单位: eLutions Integrated Systems, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1431032&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Miniaturized; Raman

This Small Business Innovation Research (SBIR) Phase II project shall prototype a wearable Raman optical system to monitor trending blood glucose levels noninvasively, continuously, and in real-time. A solution that is unobtrusive, long-running, and provides absolute glucose readings with minimal calibration is considered a "holy grail" for patients with diabetes mellitus. In the vast divide between this aspiration and the default regimen of multiple daily fingerstick measurements for single-shot glucose readings lie incredible opportunities for improvement in self-regulation and patient-specific care. Our goal is to miniaturize a Raman system into less than 10 cubic centimeters to enable transcutaneous glucose detection. Sufficient accuracy is sought so that analysis of collected data allows clinicians to provide better individualized care than is possible with either isolated fingerstick data or two-month-averaged glucose levels inferred from glycated hemoglobin (HbA1c) readings. Using a novel optical configuration developed in Phase I, further miniaturization in Phase II will reduce our laboratory bench-top system to a handheld platform that is an order of magnitude smaller and maintains the necessary throughput and sensitivity to detect glucose ex vivo.This Phase II effort will also investigate the core problem of repeatability plaguing almost all optical approaches for noninvasive glucose detection. Specifically, it will be addressed for the Raman-based spectroscopic configuration explored in Phase I. Optical as well as mechanical techniques will be employed to introduce stability into the system to mitigate contributions from ambient mechanical and physiological perturbations and disturbances that cause errant readings, throw off calibrations, and frustrate end users. Testing and validation of these techniques will be performed ex vivo, using disposed skin, tissue and blood samples to create model analogues in place of animal or human transcutaneous testing. This minimizes initial regulatory overhead while providing essential test data to ascertain detection limits, capacities for overcoming repeatability, and practicalities for usage in real-world scenarios. The end Phase II milestone is to deliver a prototype for demonstration that is capable of sufficient sensitivity, and stabilized detection and quantification of physiological levels of blood glucose that can be readied for wearable and ambulatory settings. Overcoming this key hurdle is a necessary step to advance all such optical technologies for transcutaneous detection, and one which will engage potential customers and investors for continued support toward commercialization.

该小企业创新研究 (SBIR) 第二阶段项目将构建可穿戴拉曼光学系统原型，以无创、连续、实时监测趋势血糖水平。 对于糖尿病患者来说，一种不显眼的、长期运行的、以最少的校准提供绝对血糖读数的解决方案被认为是“圣杯”。 这种愿望与每日多次指尖采血测量单次血糖读数的默认方案之间存在巨大差距，这为改善自我调节和针对患者的护理提供了令人难以置信的机会。 我们的目标是将拉曼系统小型化至不到 10 立方厘米，以实现经皮葡萄糖检测。 寻求足够的准确性，以便对收集的数据进行分析，使临床医生能够提供比孤立的指尖采血数据或从糖化血红蛋白 (HbA1c) 读数推断的两个月平均血糖水平更好的个性化护理。 使用第一阶段开发的新型光学配置，第二阶段的进一步小型化将把我们的实验室台式系统缩小到一个数量级的手持平台，并保持离体检测葡萄糖所需的通量和灵敏度。第二阶段的工作还将研究困扰几乎所有无创葡萄糖检测光学方法的可重复性的核心问题。 具体来说，它将针对第一阶段探索的基于拉曼的光谱配置进行解决。将采用光学和机械技术为系统引入稳定性，以减轻环境机械和生理扰动和干扰的影响，这些扰动和干扰会导致读数错误、偏离校准和让最终用户感到沮丧。 这些技术的测试和验证将在体外进行，使用处理过的皮肤、组织和血液样本来创建模型类似物来代替动物或人体经皮测试。 这最大限度地减少了初始监管开销，同时提供了必要的测试数据以确定检测极限、克服重复性的能力以及在现实场景中使用的实用性。 第二阶段的最终里程碑是提供一个用于演示的原型，该原型能够具有足够的灵敏度，以及稳定的血糖生理水平检测和量化，可以为可穿戴和流动设置做好准备。 克服这一关键障碍是推进所有此类经皮检测光学技术的必要步骤，并且将吸引潜在客户和投资者继续支持商业化。