Noninvasive neonatal glucose monitor

DESCRIPTION (provided by applicant): Abnormally low (hypoglycemia) and abnormally high (hypoglycemia) glucose in neonates can lead to devastating consequences. Thus, constant, accurate and safe glucose monitoring is imperative in neonatal care. However, point-of-care (POC) devices for glucose testing currently used for neonates are originally designed for adults. Thus, they do not address issues specific to neonates, including limits of accuracy at low glucose; presence of interfering substances found onlyin neonates; the limited neonatal blood volume that precludes multiple blood collection; their underdeveloped immune response; and the long term consequences of exposure to pain. To address these issues we plan to develop a neonatal specific glucose sensorthat is: (1) non-invasive/painless; (2) more accurate and sensitive than current sensors; (3) easy to use by staff; (4) and produces quick results. The method of non-invasive sampling will take advantage of the heightened permeability of the underdeveloped cutaneous layer of the neonate skin. A swab moistened with saline will be used to wick glucose on the surface of the skin and assayed using an innovative glucose biosensor developed by our group. The glucose biosensor is a recombinant glucose binding protein (GBP) responsible for chemotaxis in gram negative bacteria and, therefore, has undergone natural selection to be sensitive to very low (5M) levels of glucose. Our group has labeled the GBP with a fluorescent dye/s The glucose biosensor is a recombinant glucose binding protein (GBP) responsible for chemotaxis in gram negative bacteria and, therefore, has undergone natural selection to be sensitive to very low (5M) levels of glucose. and has built prototypes that by the end of this project will evolve into a handheld device for POC determination of glucose. The swab will be tested on standard glucose solutions, a porcine skin model and cohorts of neonates classified by gestational age. The POC device will be tested only on standard glucose solutions and the porcine skin model. Phase II will involve testing of the POC device in the neonatal intensive care unit (NICU). PUBLIC HEALTH RELEVANCE: Extremely low (hypoglycemia) and extremely high (hypoglycemia) glucose in neonates can lead to devastating consequences. Thus, constant, accurate and safe glucose monitoring is imperative in neonatal care. However, point-of-care (POC) devices for glucose testing currently used for neonates are originally designed for adults. To address these issues we plan to develop a neonatal specific glucose sensor that is: (1) non-invasive/painless; (2) more accurate and sensitive than current sensors; (3) easy to use by staff; (4) and produces quick results. A swab moistened with saline will be used to wick glucose on the surface of neonate skin and assayed using an innovative glucose biosensor developed by our group. The swab will be tested on glucose standards, an in vitro porcine skin model and preterm babies grouped by gestational age. By the end of this Phase I STTR project we plan to deliver a handheld device for POC determination of glucose ready for Phase II testing in the neonatal intensive care unit.