IN SITU SELF-CALIBRATING GLUCOSE MONITOR

描述（改编自申请人摘要）： 本申请中的工作是开发一种可靠的、连续的 皮下葡萄糖监测系统。 传感器开发技术 在过去的20年里， 实用的葡萄糖电极。 考虑到长期投资的风险 传感器电极的血管内放置，血管外放置， 皮下放置似乎是选择的情况。 然而，血管外装置的可靠性仍然存在问题 由于血糖浓度与血糖浓度之间的关系不稳定， 以及传感器/组织处的细胞外葡萄糖浓度 接口. 此外，在体内存在大量的实际困难， 必须克服校准。 持续葡萄糖监测 本申请中描述的系统解决了可靠性问题 通过：1）应用测量的组织氧数据来校正细胞外 葡萄糖测量，从而更充分地代表中心 血糖浓度;以及2）连续提供 测量血糖计算的不确定性， 体内响应时间，基于监测条件， 传感器/组织接口。 传感器系统的这些特征可以是 被视为执行自动“体内校准”，同时提供 测量不确定性信息，反映了生理 传感器/组织界面的状态和完整性。 申请人 该小组最近完成了一项第二阶段的自我校准研究， 体内血气、pH值和电解质监测仪， 原则

DESCRIPTION (Adapted from applicant's abstract): The ultimate goal of the work in this application is to develop a reliable, continuous subcutaneous glucose monitoring system. Sensor development technology over the past 20 years has resulted in production of potentially practical glucose electrodes. Given the risks associated with long-term intravascular placement of sensor electrodes, extravascular, subcutaneous placement appears to be the situation of choice. Reliability of extravascular devices, however, remains problematic because of the unstable relationship between blood glucose concentration and the extracellular glucose concentration at the sensor/tissue interface. In addition, substantial practical difficulties in vivo calibration must be surmounted. The continuous glucose monitoring system described in this application addresses the issue of reliability by: 1) applying measured tissue oxygen data to correct extracellular glucose measurements, thereby more adequately representing central blood glucose concentrations; and 2) continuously providing measurements of the uncertainties of the blood glucose calculations and in vivo response time based upon monitored conditions at the sensor/tissue interface. These features of the sensor system can be viewed as performing automatic "in vivo calibrations", while providing measurement uncertainty information which reflects the physiological status and integrity of the sensor/tissue interface. The applicant group has recently completed a phase II study of a self-calibrating in vivo blood gas, pH, and electrolyte monitor based upon a similar principle.