Fluorescence Sensor Probe for Transcutaneous Glucose Sensing

描述（申请人提供）：目前迫切需要一种用于糖尿病治疗的长期体内血糖监测设备。据信，目前全世界有超过1亿人患有糖尿病，其中美国有近1800万人患有糖尿病。在美国，这种疾病及其相关并发症被列为第七大死因。研究表明，如果血糖水平尽可能保持在接近正常水平（60-110毫克/分升），即所谓的“严格”血糖控制，这些长期并发症可以最小化。将连续血糖监测读数集成到自动胰岛素泵控制算法中，可能会大大提高糖尿病患者胰岛素治疗的安全性和有效性。BioTex公司开发了一种微创荧光亲和血糖传感器，这是目前在糖尿病研究和治疗中应用的最有前途的长期血糖传感技术之一。拟议研究的最终目标是推进我们的荧光传感器，为第二阶段完成后的初步人体试验做准备。为了完成这一具有挑战性的目标，我们将在第二阶段集中努力完成以下任务：I. BioTex的化学家和合作者stephen Massia博士和fred Clubb博士将设计、测试和优化合适的化学方案，用于在传感器外表面的仿生层共价附着，以提高生物相容性，从而扩展大鼠体内传感器的功能。2。BioTex的化学家和工程师将通过冷冻干燥/真空包装来优化传感器的预灭菌配方方案。3。BioTex的化学家将与商业机构合作进行研究，以优化基于辐射的灭菌方法的条件，并验证灭菌的有效性。BioTex的工程师将设计和制造一种用于传感器传送的设备，并完成传感器检索的研究。V. BioTex的科学家们将与内分泌学家Eric orzeck博士合作，指导我们在项目完成后设计出可行的传感器，为人类研究做好准备。我们坚信，大量的初步工作和我们的专家团队将使我们能够成功地实现提议的第二阶段目标。BioTex, Inc.开发的血糖传感技术与公共卫生的相关性在于，需要找到治疗手段，以尽量减少甚至消除糖尿病对人类健康的破坏性影响（特别是青少年I型糖尿病），如失明、肾衰竭和死亡率增加。如果成功，BioTex的血糖传感技术将与胰岛素泵结合，通过在最少的用户干预下实现自主血糖控制，提高糖尿病患者的整体健康水平。总体结果将是糖尿病患者的生活更健康，并为社会降低糖尿病治疗的医疗费用。

DESCRIPTION (provided by applicant): 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.