The overall objective of this Competing Continuation project is to develop VivaScan s handheld, noninvasive, personal blood glucose monitor prototype into a market-ready device and submit a modular PMA application to the FDA that will allow us to bring it to market. This will lead VivaScan into the commercialization phase of our product development, and bring millions of diabetics a way to monitor their disease without the need to prick their fingers. Under previous SBIR grants and company funds, VivaScan has developed and successfully tested VS175 an advanced laboratory prototype handheld noninvasive blood glucose monitor. This is a small (17x10x3 cm) instrument that uses optical means to noninvasively measure glucose in blood. The measurement site is the ear lobe. During a measurement that lasts ~20 seconds, the instrument is placed under the ear, the ear is gently squeezed, light is shone thru the ear lobe and its blood content modulated. The measurement operation is based on the Optical TM Bridge method. It uniquely nulls out the background absorption of the tissue, overcoming the major problem of optical blood glucose measurements. Our successful Phase II pilot study on 25 volunteers produced 2638 data pairs with an overall average absolute prediction error of 17% and 99.2% of the measurement data in the clinically acceptable A and B zones of the Clarke error grid (70.3% within A zone). The latest measurements achieved 11.7% error on 460 data pairs.
The aims for the proposed SBIR Competing Continuation project include: 1) Port VS175 device hardware and software towards a pre-manufacturing prototype (PMP) platform;2) Develop PMP and manufacture twenty VS177 monitors;3) Set up and execute GMPs under FDA guidance;4) 5) Perform in-house and off-site preclinical studies to evaluate instrument performance;6) Complete Clinical Studies in support of a modular PMA;and 7) submit a modular PMA to the FDA. Our accuracy goal is to achieve 95% of measurements with <20% error and instrument reliability >90%. PUBLIC HELTH
Diabetes is a miserable disease and a serious public health problem, affecting more than 20.8 million people in the United States today. The NIH Diabetes Control &Complications Trial provided compelling evidence that frequent blood-glucose monitoring (more than 4 times a day) and tight blood-glucose control offer significant benefits to the long-term health of a diabetic person [DCCT]. Previous studies show that on average, diabetic individuals test their glucose only 1.6 times a day (instead of the preferred 6-10 times). This is an indication that existing invasive finger stick glucose measuring devices do not serve their purpose. They are simple to use;however, diabetic individuals fail to use them routinely mainly because finger stick tests are painful, expensive, and messy. There is an urgent need for an instrument that can measure blood glucose noninvasively. VivaScan is at an advanced stage of developing a noninvasive handheld glucose monitor that uses measurements of the light transmitted through the earlobe. Although the accuracy of results is nearing that of the current gold standard, invasive finger stick testing, further development is needed to shift from a laboratory prototype instrument to a manufacturing prototype that is ready for FDA testing. Our ultimate goal is to bring our noninvasive blood glucose monitor to the market.