There is an urgent need for a long-term in vivo glucose-monitoring device for diabetes therapy. Diabetes is currently believed to afflict over 100 million people worldwide and nearly 18 million in the United States. In the U.S. this disorder, along with its associated complications, is ranked as the seventh leading cause of death. Research indicates that these long-term complications can be minimized in diabetics if blood glucose levels are maintained as near normal levels (60-110 mg/dL) as possible, so called """"""""tight"""""""" glucose control. The integration of continuous glucose monitor readings into an automatic insulin pump control algorithm may substantially increase both the safety and effectiveness of insulin therapy in diabetics. BioTex, Inc. has developed a superior concept of a minimally invasive fluorescence affinity glucose sensor which is one of the most promising long-term glucose-sensing technologies currently being pursued for application in diabetes research and therapy. The ultimate objective of the proposed research is to advance our fluorescence sensor, in preparation for preliminary human trials subsequent to completion of Phase II. To accomplish this challenging goal, we will concentrate our efforts in Phase II on the following tasks: I. BioTex chemists and collaborators Dr.Stephen Massia and Dr.Fred Clubb will design, test, and optimize suitable chemical protocols for covalent attachment of biomimetic layer(s) on outer sensor surface for improved biocompatibility and, hence, extended in vivo sensor functionality in rats. II. BioTex chemists and engineers will perform studies to optimize a pre-sterilization formulation protocol of sensor by freeze-drying/vacuum-packaging. III. BioTex chemists in collaboration with commercial facilities will perform studies to optimize conditions of radiation-based sterilization methods and to validate the efficacy of sterilization. IV. BioTex engineers will design and manufacture a device for sensor delivery, and complete study for sensor retrieval. V. BioTex scientists will collaborate with endocrinologist Dr. Eric Orzceck, MD, in order to guide us towards a feasible sensor design ready for human studies after completion of this project. We believe strongly that both the substantial amount of preliminary work and our team of experts will enable us to successfully accomplish the proposal Phase II objectives. The relevance of the glucose-sensing technology developed by BioTex, Inc. to public health lays in the need to find therapeutic means to minimize or even eliminate the devastating effects of diabetes to human health (especially juvenile Type I diabetes), like blindness, kidney failure, and increased mortality. If successful, the BioTex glucose- sensing technology will in conjunction with an insulin pump improve overall health level of people with diabetes by enabling autonomous blood-sugar control with minimal user intervention. The overall result will be a healthier life for people with diabetes and lower medical costs for diabetes care for the society. ? ? ?
