Hypoglycemia represents a dangerous acute condition for neonates and for diabetics of all ages. For neonates, careful monitoring of plasma glucose concentrations in at-risk newborns over the first few hours of lif3e has become standard medical practice throughout the nation to guard against hypoglycemia. However, today's state-of-the-art techniques for accurately detecting hypoglycemia do not adequately address the needs of neonates nor of their care providers. In fact, manufacturers are careful to not include the key hypoglycemic ranges and some specifically warn care providers in writing that the systems are not be used for neonate testing. The overall primary goal of this SBIR project is to develop a specialized, economical, hand-held glucose-sensor technology that will overcome the limitations of current glucose tests for neonates. We expect to primary address the 10-50mg/dL range, with a secondary goal of addressing the entire relevant neonate range (perhaps 10 to 90 mg/dL). Our approach for Phase I will be to investigate the feasibility of combining a new electrochemical sensor technology with a new generation of a proprietary, prototype, hand-held point-of-care monitor that has already been devoted by AndCare.
A successful Phase I would lead to a Phase II prototype-development program designed to validate our approach and to prepare for follow-up on Phase III development and commercialization. The resulting product would directly address a significant neonate marker in the U.S. (4 million annual birth) and in a number of countries to production of an improved point-of-care glucose-monitoring product for Type I capabilities for aggressive diabetic monitoring.