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Assesment of a Chronic Subcutaneous Glucose Sensor

慢性皮下血糖传感器的评估

基本信息

批准号：
6621918
负责人：
WILLIAM KENNETH WARD
金额：
$ 19.28万
依托单位：
LEGACY HEALTH SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-04-01 至 2004-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6621918
关键词：
angiogenesis bioengineering /biomedical engineering biomedical equipment development biosensor device blood glucose diabetes mellitus electrodes hypoglycemia immunocytochemistry laboratory rabbit medical implant science monitoring device statistics /biometry telemetry vascular endothelial growth factors

项目摘要

DESCRIPTION (provided by applicant): In the United States, diabetes mellitus is the leading cause of end-stage kidney failure, blindness in adults under age 65, and is the second leading cause (after trauma) of limb amputation. Poorly-controlled glucose levels are the major cause of these complications, but tight glycemic control is difficult to safely achieve using present technology. While a continuously-functioning glucose sensor would assist in safely achieving tight glucose control, such devices are typified by instability and loss of output over time due to the formation of foreign-body scar tissue, which eventually surrounds the sensors. Miniaturized sensors could be implanted under the skin with minimal discomfort. It is possible that the surrounding scar capsule could be made much more "friendly" to a glucose sensor by the slow release of growth factor compounds from the sensor surface. The hypothesis is that such compounds would reduce the scar fibrosis and generate many blood vessels in the capsule. These blood vessels are important to the long-term function of the sensor given its need for continuous glucose and oxygen delivery. A study will initially be performed in order to ascertain the optimal dosage of the growth factor. Then the growth factor (or saline control) will be slowly released over one month from miniaturized pumps into the tissue, which directly contacts the sensor. The thickness of the capsule and the formation of new blood vessels will measured by standard histologic staining techniques and by endothelial Factor Vifi immunohistochemistry. Another major problem of glucose sensors is short-term drift. It is frequently observed but poorly understood. It now appears that it may be possible to obtain stable readings from simultaneous recordings of multiple sensor electrodes. The technique which will be used to separate the accurate electrode signals from the inaccurate (outlying) signals is from the field of median statistics and is called the ZMAD method of Rousseeauw. The ZMAD data processing will be performed prospectively and continuously. In addition, the sensors and their transmitters will be miniaturized with the help of a biotelemetry company, MiniMitter. The body can be hostile to compounds which coat implanted devices. We will compare two promising polyurethanes as sensor coats: a carbonate based- vs. ether-based polymer. We will compare their long term function in studies using rabbits, which will be also be used to ascertain the effect of the growth factors and the real-time data processing.

描述（由申请人提供）：在美国，糖尿病是导致晚期肾衰竭的主要原因， 65，是截肢的第二大原因（仅次于创伤）。血糖控制不佳是这些并发症的主要原因，但是使用目前的方法难以安全地实现严格的血糖控制技术.虽然连续工作的葡萄糖传感器将有助于安全地实现严格的葡萄糖控制，这种装置的典型代表是由于异物的形成，随着时间的推移输出不稳定和损失疤痕组织，最终包围传感器。微型传感器可以植入皮肤下，带来最小的不适感。有可能周围的疤痕囊可以对葡萄糖传感器更加“友好”，通过从传感器表面缓慢释放生长因子化合物。的一种假设是，这种化合物将减少瘢痕纤维化并产生胶囊里有很多血管这些血管对于考虑到其对连续葡萄糖的需求，传感器的长期功能，氧气输送最初将进行一项研究，以确定生长因子的最佳剂量。然后将生长因子（或生理盐水对照）将在一个月内从微型泵缓慢释放到组织中，其直接接触传感器。胶囊的厚度和通过标准组织学染色测量新血管的形成技术和内皮因子Vifi免疫组织化学。另一个主要葡萄糖传感器的问题是短期漂移。它经常被观察到，不太了解。现在看来，它可能会获得稳定的来自多个传感器电极的同时记录的读数。的该技术将用于将精确的电极信号与不准确的（离群的）信号来自中值统计领域，叫做ZMAD方法。ZMAD数据处理将是进行前瞻性和连续性研究。此外，传感器及其在一家生物遥测公司的帮助下，迷你米特身体可能对植入装置的涂层化合物有敌意。我们将比较两种有前途的聚氨酯作为传感器涂层：碳酸酯基- 相对于醚基聚合物。我们将在研究中比较它们的长期功能使用兔子，这也将被用来确定生长的影响，因素和实时数据处理。