Optimization of Kinetics in a Novel Glucose Sensor

描述（由申请人提供）：本阶段II SBIR涉及以下测试： 一种体内微创葡萄糖传感器。糖尿病是一种越来越常见的 这是一种终身疾病，并与许多并发症有关。它负责 估计占所有医疗保健支出的10- 15%。有效 治疗已被证明可以预防或延迟许多相关的 并发症目前最常见的治疗方法包括节食、锻炼和 自我血糖监测（SMBG）。对现有方法的改进 将使患者能够并鼓励他们更多地监测血糖水平， 从而改善糖尿病患者的总体健康和生活质量 人口 这项技术是基于一个小的光学传感器植入，是荧光 并且可以通过皮肤检测到。我们将最终确定传感器配置， 获得最快的动力学。必须进行动物功效试验， 该传感器更接近于人体临床试验。传感器的性能 将在体内进行研究，以证明传感器与血液相关 葡萄糖，并在耐受性测试中遵循葡萄糖变化。体内试验将 执行以确定重新校准间隔、再现性和 传感器的准确性。传感器的寿命和生物相容性将 也要坚决。 拟定商业应用： 对目前测量葡萄糖水平的方法的改进将使得并鼓励糖尿病患者能够更频繁地在家中测量葡萄糖水平，从而改善糖尿病人群的总体健康和生活质量。葡萄糖传感技术的进步将极大地影响糖尿病市场。目前存在一个巨大的商业市场，用于对葡萄糖检测进行创新性改进，例如本研究中描述的微创葡萄糖传感器和配套仪表。

DESCRIPTION (provided by applicant): This Phase II SBIR involves the testing of a minimally invasive glucose sensor in vivo. Diabetes is an increasingly common lifelong disease and is associated with many complications. It is responsible for an estimated 10-15 percent of all health care expenditures. Effective treatment has been shown to prevent or delay many of the associated complications. The most common current treatments include diet, exercise, and self-monitoring of blood glucose (SMBG). An improvement to the current method would enable and encourage patients to monitor their glucose levels more closely and thus improve the general health and quality of life of the diabetic population. The technology is based on a small optical sensor implant that is fluorescent and detectable through the skin. We will finalize the sensor configuration to obtain the fastest kinetics. Animal efficacy trials must be performed to bring the sensor closer to clinical trials in humans. The performance of the sensor will be studied in vivo to demonstrate that the sensor correlates with blood glucose and follows glucose changes in tolerance tests. In vivo testing will be performed to determine the recalibration interval, the reproducibility, and the accuracy of the sensor. The lifetime and biocompatibility of the sensor will also be determined. PROPOSED COMMERCIAL APPLICATION: An improvement in the current method of measuring glucose levels would enable and encourage diabetic patients to measure glucose levels more frequently at home and thus improve the general health and quality of life of the diabetic population. An advance in the glucose sensing technology would greatly impact the diabetes market. A large commercial market currently exists for innovative improvements on glucose detection such as the minimally invasive glucose sensor and accompanying meter described in this research.