USDA Sample Proposal

Hypoglycemia represents a dangerous acute condition for neonates and fordiabetics of all ages. For neonates, careful monitoring of plasma glucoseconcentrations in at-risk newborns over the first few hours of life has becomestandard medical practice throughout the nation to guard against hypoglycemia.However, today’s state-of-the-art techniques for accurately detectinghypoglycemia do not adequately address the needs of neonates nor of their careproviders. In fact, manufacturers are careful to publish the testing ranges forwhich their systems have been “validated”—which do not include the keyhypoglycemic ranges—and some specifically warn care providers in writing that the systems are not to be used for neonate testing. The overall goal of this multi-phase SBIR project is to develop a specialized,economical, hand-held glucose-senor technology that will overcome thelimitations of current glucose tests for neonates. We expect to primarily addressthe 10to 50-mg/dL range, with a secondary goal of addressing the entirerelevant neonate range (perhaps 10 to 90 mg/dL). Our approach for Phase I willbe to investigate the feasibility of combining a novel electrochemical sensortechnology with a new generation of a proprietary, prototype hand-held point-of-care monitor that has already been developed by our firm. We have assembleda highly qualified interdisciplinary team to carry out this work—which experts indiabetes and neonatal care—and the principal investigator is recognized as aleading researcher in the area of electrochemical devices. A successful Phase I will lead to a Phase II prototype-development programdesigned to validate our approach through initial clinical trials and to prepare forfollow-on Phase III development, FDA approvals, and ultimate commercialization.The resulting product would serve a significant neonate population in the U.S. (4million annual births) and a larger international market. Moreover, the technicalsuccess achieved would likely lead directly to production of an improved point-of-care glucose-monitoring product for all Type I diabetics who require extremelyaccurate, reliable, low-cost home-testing capabilities for aggressive diabeticmonitoring.