Assesment of a Chronic Subcutaneous Glucose Sensor

描述(申请人提供)：在美国，糖尿病是 导致终末期肾功能衰竭的主要原因是未成年失明 65岁，是截肢的第二大原因(仅次于创伤)。 血糖水平控制不佳是这些并发症的主要原因， 但严格的血糖控制目前很难安全地实现。 技术而持续运行的葡萄糖传感器将有助于 安全地实现严格的血糖控制，这种设备的典型特征是 由于异物的形成，随着时间的推移产量不稳定和损失 最终包围传感器的疤痕组织。微型传感器可以 植入皮肤下，只有最小的不适。有可能是因为 周围的疤痕胶囊可以变得对血糖传感器更“友好” 通过从传感器表面缓慢释放生长因子化合物。这个 假说是，这种化合物会减少瘢痕纤维化并产生 包膜内有许多血管。这些血管对 传感器的长期功能，因为它需要连续血糖和 氧气输送。最初将进行一项研究，以确定 生长因子的最佳用量。然后是生长因子(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， 它直接与传感器接触。胶囊的厚度和 新血管的形成将通过标准的组织学染色来测量 技术和内皮因子Vifi免疫组织化学方法。另一大专业 葡萄糖传感器的问题是短期漂移。这是经常被观察到的，但 人们对此知之甚少。现在看来，有可能获得稳定的 来自多个传感器电极的同时记录的读数。这个 这项技术将用于将准确的电极信号从 不准确的(离线)信号来自中值统计领域，并且 称为Rousseauw的ZMAD方法。ZMAD数据处理将是 前瞻性地、持续地执行。此外，传感器和它们的 在生物遥测公司的帮助下，发射器将被微型化， 迷你米特。人体可能对包裹植入设备的化合物怀有敌意。 我们将比较两种作为传感器涂层的有前景的聚氨酯：一种碳酸酯基涂层。 与以乙醚为基础的聚合物。我们将在研究中比较它们的长期作用 使用兔子，这也将被用来确定生长的效果 影响因素和数据的实时处理。

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.