5-Day Fiber-Coupled Sensor Interstitial Glucose

5 天光纤耦合传感器间质血糖

• 批准号: 7156304
• 负责人: Ralph Ballerstadt
• 金额: $ 10万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7156304
• 关键词: bioengineering /biomedical engineering; biomaterial compatibility; biomedical equipment development; biosensor device; biotechnology; blood glucose; computer program /software; computer system hardware; fiber optics; fluorescence spectrometry; implant; interstitial; laboratory rat; mathematical model; medical implant science; miniature biomedical equipment; patient monitoring device; skin; swine

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.

描述（由申请人提供）： 项目摘要/摘要：该第一阶段项目的目标是开发第一代原型间质葡萄糖传感器，设计用于糖尿病患者 3 至 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具有改进的化学稳定性的荧光（基于 FRET）方法的成功，并继续开发该技术用于长期完全植入式传感器。然而，我们相信通过以微创、短期、光纤耦合方法利用我们稳定的荧光检测可以得到更直接的解决方案。我们将首先进行旨在设计和测试我们的传感器技术的坚固光纤耦合实施例的实验，以成功进行短期血糖监测。我们将实现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后，我们将在小型和大型动物体内放置原型传感器，并研究它们在几天内对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，考虑传感器响应和血糖水平之间的滞后时间。最终结果将是在 5 天的时间内彻底了解用于小型和大型动物血糖监测的光纤耦合传感器的功能。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：全球被认为患有糖尿病的 1 亿人迫切需要一种实时、连续的血糖监测设备。维持正常的血糖水平是预防疾病长期并发症的最佳方法，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为短期（3-5天）连续监测提供准确、可靠且方便患者使用的解决方案。

项目成果

A human pilot study of the fluorescence affinity sensor for continuous glucose monitoring in diabetes.

用于糖尿病患者连续血糖监测的荧光亲和传感器的人体试点研究。

• DOI: 10.1177/193229681200600222
• 发表时间: 2012
• 期刊: Journal of diabetes science and technology
• 影响因子: 5
• 作者: Dutt-Ballerstadt,Ralph;Evans,Colton;Pillai,ArunP;Orzeck,Eric;Drabek,Rafal;Gowda,Ashok;McNichols,Roger
• 通讯作者: McNichols,Roger