5-Day Fiber-Coupled Sensor Interstitial Glucose

项目概述/摘要：本一期项目的目标是开发第一代间质葡萄糖传感器原型，用于糖尿病患者3 - 5天的监测。我们之前已经在广泛的体外研究和初步体内研究中证明了荧光（基于fret）方法的成功，该方法具有改进的稳定化学性质，并将继续开发该技术用于长期完全植入式传感器。然而，我们相信，通过利用我们稳定的荧光检测技术，一种微创、短期、纤维耦合的方法，可以获得更直接的解决方案。我们将首先进行实验，目的是设计和测试我们的传感器技术的坚固的光纤耦合实施方案，以成功地进行短期血糖监测。我们将实现一个可穿戴光纤测量和读出设备的原型。在对传感器进行广泛的体外测试之后，我们将把传感器原型放置在小型和大型动物身上，研究它们对几天内不同血糖浓度的反应，然后对传感器部位进行宿主反应分析。最后，我们将分析收集的体内血糖数据，并开发体内校准算法，考虑传感器响应与血糖水平之间的滞后时间。最终的结果将是彻底了解纤维耦合传感器在5天内对小型和大型动物进行葡萄糖监测的功能能力。如果成功，我们相信这项技术将在第二阶段进行人体评估。项目简介：全球1亿糖尿病患者迫切需要一种实时、连续的血糖监测设备。维持正常的血糖水平是预防糖尿病长期并发症的最好方法，需要持续监测血糖水平，以便做出适当的调整（胰岛素治疗或饮食）。我们相信所提出的传感器可以提供短期（3-5天）连续监测的解决方案，该解决方案将准确，可靠，方便患者使用。

DESCRIPTION (provided by applicant): Project Summary/Abstract: The goal of this Phase I project is to develop a first-generation prototype interstitial glucose sensor designed for 3 to 5 day monitoring in diabetic patients. We have previously demonstrated the success of a fluorescence (FRET-based) approach with an improved stable chemistry in extensive in vitro studies and in preliminary in vivo studies and continue to develop this technology for a long-term fully implantable sensor. However, we believe a more immediate solution can be had by leveraging our stable fluorescent assay in a minimally-invasive, short-term, fiber-coupled approach. We will first conduct experiments aimed at engineering and testing a rugged fiber-coupled embodiment of our sensor technology for successful short-term glucose monitoring. We will implement a prototype of a wearable fiber-optic measurement and read-out device. Subsequent to extensive testing of the sensor in vitro, we will place prototype sensors in small and large animals and study their response to varying blood glucose concentrations over several days, followed by host-response analysis of sensor sites. Finally, we will analyze the collected in vivo blood glucose data and develop algorithms for in vivo calibration, accounting for lag-time between sensor response and blood glucose levels. The end result will be a thorough understanding of the functional capability of the fiber-coupled sensor for glucose monitoring in small and large animals over a period of 5-days. If successful, we believe this technology will be poised for evaluation in humans in Phase II. Project Narrative: There is an urgent need for a real-time, continuous, glucose monitoring device for the 100 million people worldwide believed to have diabetes. Maintaining normal levels of blood glucose is the best way to prevent long-term complications of the disease and requires continuous monitoring of glucose levels so that proper adjustments can be made (insulin therapy or diet). We believe the proposed sensor can provide a solution for short-term (3-5 days) continuous monitoring that will be accurate, reliable, and convenient for patient use.