Fluorescence Sensor Probe for Glucose Sensing

描述(由申请人提供)： 糖尿病是一种代谢性疾病，目前困扰着美国约1600万人和全球1亿人。在美国，糖尿病及其相关并发症是第七大死因。有效的糖尿病管理需要定期测量血糖，而血糖传感技术的改进将使糖尿病患者能够得到更好的护理和调节。本研究项目的重点是开发和表征一种微创近红外荧光亲和传感器，用于经皮皮肤组织间质液中的血糖监测。提出的植入装置的概念是目前葡萄糖传感器研究中最有前途的技术之一。其中一位主要研究人员此前曾进行过重要的长期性能测试，证明传感器的主要组成部分--葡萄糖敏感蛋白刀豆蛋白A能够在体温下保持功能一年以上。这些稳定性测试数据对于确保荧光亲和传感器在多个月内可靠和准确的性能至关重要。我们计划开发、建造和测试一种皮下植入的小型传感器，这种传感器可以基于皮肤的荧光测量快速、无痛地感知血糖。该传感器将被特别设计为与皮肤光学兼容，并将服从廉价的仪器。在这项工作中，我们将在体外测试该传感器，并在大鼠模型中进行初步的体内测试。这项研究的预期结果将是一种用于血糖监测的小型化、坚固耐用、生物兼容的亲和传感器原型，该传感器在无毛大鼠模型中保持至少4周的功能，重新校准频率较低，约为每周一次。

DESCRIPTION (provided by applicant): Diabetes mellitus is a metabolic disease, which currently afflicts some 16 million in the US and 100 million people worldwide. In the US, diabetes and its associated complications are the seventh leading cause of death. Effective management of diabetes requires regular measurement of blood sugar, and improvements in glucose sensing technology will enable superior care and regulation of diabetic blood sugar. The focus of this research project is to develop and characterize a minimally invasive near-infrared fluorescence affinity sensor designed for transcutaneous glucose monitoring in interstitial fluid in subdermal skin tissue. The concept of the proposed implant device is one of the most promising technologies currently pursued in glucose sensor research. Significant long-term performance tests have been previously conducted by one of the principle investigators demonstrating that the glucose-sensitive protein Concanavalin A, the primary component of the sensor, has the capability to stay functional at body temperature for over one year. These stability test data are pivotal for ensuring reliable and accurate performance of the fluorescence affinity sensor over many months. We plan to develop, build, and test a small subcutaneously implantable sensor that will allow rapid and painless glucose sensing based on fluorescence measurements through the skin. The sensor will be specifically designed to be compatible with skin optics and will be amenable to inexpensive instrumentation. In this work, we will test the sensor in vitro and preliminarily in vivo in a rat model. The anticipated results of this study will be a miniaturized, rugged, biocompatible prototype of the affinity sensor for glucose monitoring that remains functional for at least 4 weeks in the hairless rat model with a low re-calibration frequency of approximately once a week.