Development of a Noninvasive Glucose Monitor

DESCRIPTION (provided by applicant): VivaScan has developed and successfully tested a prototype of a handheld blood glucose monitor. It uses noninvasive optical means to measure the glucose level in the earlobe's blood plasma. The instrument's operation is based on measurements of near-infrared (NIR) light absorption/scattering in tissue using the VivaScan's patented Optical Bridge(tm) (OB) method. The OB uniquely nulls out the background absorption of the tissue, overcoming the major problem of optical blood glucose measurements. The long-term goal of this project is to develop, test, and market a personal device that measures blood glucose noninvasively from the finger. The ultimate measurement accuracy goal is that of current invasive devices, its use should be simple for lay persons, and its cost should make it accessible for personal use. Its operation should be made unobtrusive and automatic, enabling its use on children, sleeping or unconscious patients. We will modify our prototype of a handheld blood glucose monitor for finger transflectance (reflectance from deeper tissue structures, not skin surface), instead of earlobe transmission measurements. The main reasons for proposing finger measurements are: 1) a finger is typically used for medical optical measurements (like pulse oximetry); 2) it provides a more stable ergonomic measurement platform than the earlobe, resulting in less motion artifacts; 3) finger measurements do not require active participation of the user; and 4) finger measurements are easier to perform, allowing for measurements during daytime and sleep periods. We conclude that the finger is a better noninvasive measurement site than the earlobe. The goal of the proposed Phase I work is to evolve our pilot laboratory prototype instrument into a more automated device, reduce it to a handheld size, enhance it, test it, and achieve ease of operation. The specific aims of the Phase I proposal are to: 1) Design and build a noninvasive transflectance finger blood glucose monitoring device based upon the existing handheld instrument built for earlobe measurements; 2) Perform bench tests to determine its operational characteristics; and 3) Evaluate its performance in initial patient pilot studies. Results will be compared with our current ear transmission instrument and a reference finger prick device.