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

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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.