DEVELOPMENT OF A NONINVASIVE GLUCOSE MONITOR

DESCRIPTION (provided by applicant): The goal of this project is to develop a portable, noninvasive, personal blood glucose monitor. VivaScan has developed and successfully tested a laboratory prototype instrument based on the Optical Bridge TM (OB) method. The OB uniquely nulls out the background absorption of the sample, overcoming the major problem of optical blood glucose measurements. Our successful Phase I diabetic patient study produced 96% of the measurement data in the clinically acceptable A and B zones of the Clarke error grid. The aims for Phase II include: 1) enhance electronics with microcontroller; 2) redesign and miniaturize the optics and device mechanics; 3) investigate the use of optical interference filters for acousto-optical tunable filters (AOTF) substitutes; 4) replace expensive AOTF, used for wavelength generation, with less expensive devices; 5) further enhance the glucose measurement algorithms; and 6) build four portable devices and test their performance with patients. Overall, the goal of the proposed work is to extend our laboratory prototype system to a patient oriented device, with improved accuracy, portability, ease of operation and affordability. Subsequent FDA approval of a practical portable in-home blood glucose monitor will be sought, allowing diabetic patients to noninvasively and painlessly monitor their glucose levels throughout the day. PROPOSED COMMERCIAL APPLICATIONS: Our market analysis suggests that from 500,000 to 4.4 million diabetic individuals could use a non-invasive glucose monitor. The global market would increase these projections by a factor of 2 or more.