SBIR-STTR Award

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.

Thesaurus Terms:
biomedical equipment development, blood glucose, clinical biomedical equipment, diabetes mellitus, noninvasive diagnosis, portable biomedical equipment bioengineering /biomedical engineering, clinical research, human subject

The goal of this project is to develop a small handheld device that can be used for both near continuous and discrete noninvasive measurement of blood glucose from the finger. VivaScan has developed and successfully tested several noninvasive blood glucose monitor laboratory prototypes that use the earlobe as the measurement site. Their operations are based on measurements of near-infrared (NIR) light attenuation by glucose using the patented Optical BridgeTM (OB) method. The OB uniquely nulls out the background attenuation of the tissue, overcoming the major problem of optical blood glucose measurements. In the Phase I study, VivaScan developed a prototype portable device that noninvasively measures blood glucose from the finger. Its tests produced 98.2% of the data (877 data pairs) in the clinically acceptable A & B zones in the Clarke error grid, with an average measurement error of 18.5% or 20.5 mg/dl. Based on the Phase I study, we concluded that the finger is a better noninvasive measurement site than the earlobe because: 1) it is a more ergonomic measurement site; 2) finger measurements do not require active participation of the user allowing also for automated near continuous measurements on sleeping or unconscious patients (e.g. in hospital environment); and 3) finger measurements are easier to perform. In addition, numerous opportunities for improvement have been identified. Overall, the goal of the proposed work is to extend our laboratory prototype portable system to a patient oriented affordable small handheld device. The main aims for Phase II include: 1) develop a custom laser diode system light source; 2) enhance the electronics; 3) redesign and miniaturize the optics and device mechanics; 4) design a handheld system; 5) further enhance the glucose measurement algorithms; 6) achieve one point calibration; 7) build three handheld devices; and 8) test their performance with patients. Our performance goals include: 1) achieve a blood glucose estimation accuracy nearing existing individual finger prick invasive blood glucose measurement devices (=?15%); 2) achieve both near continuous and discrete measurements; and 3) achieve instrument stability requiring one point calibration (with a finger prick device) less than once a week. Subsequent FDA approval of a handheld personal blood glucose monitor will be sought. More than 18 million people in the United States are afflicted with diabetes. Poor management of the disease, (often due to the patient's reluctance to stab themselves for the necessary blood sugar reading), results in debilitating complications ranging from blindness to renal failure. Several national studies have concluded that these complications could be prevented by more frequent testing of blood sugar, which would be facilitated by a painless, bloodless glucose monitor such as the one we propose to develop here.

Public Health Relevance:
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Thesaurus Terms:
Biotechnology, Blood Glucose, Light Scattering, Optical Polarization, Patient Monitoring Device, Portable Biomedical Equipment, Technology /Technique Development Clinical Trial Phase I, Computer Program /Software, Diabetes Mellitus, Fiber Optics, Finger, Laser, Longitudinal Human Study, Mathematics Clinical Research, Human Subject