IN SITU SELF-CALIBRATING GLUCOSE MONITOR

原位自校准血糖监测仪

• 批准号: 2016924
• 负责人: Justin S Clark
• 金额: $ 9.99万
• 依托单位: MEDICAL PHYSICS, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2016924
• 关键词: biomaterials; biomedical equipment development; biosensor device; blood glucose; clinical biomedical equipment; diagnosis design /evaluation; diagnosis quality /standard; electrodes; implant; patient monitoring device; serology /serodiagnosis; sheep

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.

描述(改编自申请人的摘要)：的最终目标 本应用程序的工作是开发一个可靠的、连续的 皮下血糖监测系统。传感器开发技术 在过去的20年里导致了潜在的 实用的葡萄糖电极。鉴于与长期投资相关的风险 传感器电极的血管内放置，血管外， 皮下放置似乎是首选的情况。 然而，血管外装置的可靠性仍然存在问题。 因为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 界面。此外，在活体内存在实质性的实际困难 必须克服校准问题。连续血糖监测 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 血糖测量，从而更好地代表中枢 血糖浓度；2)持续提供 血糖计算的不确定度的测量和 体内反应时间基于监测的条件在 传感器/组织接口。传感器系统的这些特征可以是 被视为正在执行自动的“体内校准”，同时提供 反映生理学的测量不确定度信息 传感器/组织界面的状态和完整性。申请人 集团最近完成了一项自校准的第二阶段研究 体内血气、pH和电解质监测仪基于类似的 原则性的。