Electrochemical Home Monitoring System for Lithium Blood Level

家用电化学锂血浓度监测系统

• 批准号: 8336802
• 负责人: LINDA A TEMPELMAN
• 金额: $ 51.04万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8336802
• 关键词: Adult; Affect; Algorithms; Bipolar Disorder; Blinded; Blood; Blood Chemical Analysis; Blood Tests; Blood specimen; Boron; Caregivers; Cells; Characteristics; Chronic; Clinic; Clinical; Collaborations; Communication; Communities; Complex; Data; Data Analyses; Detection; Development; Diamond; Disadvantaged; Drops; Electrochemistry; Electrodes; Electronics; Ensure; Evaluation; Fingers; General Hospitals; Goals; Hand; Health Care Costs; Home environment; Human; Ions; Laboratories; Liquid substance; Lithium; Lithium Carbonate; Manic; Manic Disorder; Massachusetts; Measurement; Measures; Mediation; Medical; Mental Health; Methods; Microelectrodes; Monitor; Office Visits; Patient Care; Patients; Performance; Pharmacological Treatment; Pharmacotherapy; Phase; Physicians; Physiologic pulse; Physiological; Plasma; Potassium; Process; Quality of life; Reading; Recording of previous events; Reporting; Research; Sampling; Sensitivity and Specificity; Serum; Simulate; Small Business Innovation Research Grant; Sodium; System; Systems Analysis; Techniques; Technology; Testing; Therapeutic; Time; Work; aqueous; base; catalyst; computerized data processing; cost; cost effective; design; dosage; effective therapy; glucose monitor; hospital laboratories; improved; innovation; instrument; instrumentation; medical specialties; meetings; method development; miniaturize; operation; potassium ion; programs; prototype; research and development; sensor; sodium ion; success; technology development; validation studies

PROJECT SUMMARY/ABSTRACT Electrochemical Home Monitoring System for Lithium Blood Level Lithium in the form of lithium carbonate is an important pharmacological treatment option in bipolar disorder (BD) and other conditions. However, lithium has a narrow therapeutic treatment range and its use requires careful monitoring of a patient's lithium blood level, particularly during the initiation of treatment. Current monitoring techniques are inconvenient and costly, requiring a clinical analytical laboratory. There is no commercially-available system for home measurement of blood lithium. The goal of this program is the development of an electrochemically-based detection method packaged into a portable, self-contained, easy-to-use instrument/system for the analysis of lithium. It will be appropriate for use in a home setting for the monitoring of lithium level for BD patients or other patients utilizing lithium treatment. It could also be used in the clinician's office for real-time readings during office visits. A major advantage of the proposed technology is that electrochemical techniques can be packaged into instruments for automated operation in the home which makes them very inexpensive and convenient compared to other laboratory-based analytical techniques. The final home lithium monitor product will have the same ease-of-use of a home glucose monitor and provide the clinician with real- time lithium measurements needed for optimal and cost-effective treatment of the patient. This instrument will reliably and accurately determine the lithium concentration within several minutes after the patient supplies a blood sample by finger prick and the results will be reported in real time to the clinician. Frequent home monitoring could be used both to regulate dosage and to confirm patient is taking the prescribed mediation. This will improve patient care as well as decrease medical costs. During Phase I, Giner, Inc. developed sensor design configurations, with high performance electrode material, and operating conditions which demonstrated feasibility of electrochemical detection of the relevant range (0.2-3 mM) of lithium ion (Li+) in an aqueous medium, including a physiological fluid simulant. The ability to measure lithium ion concentration in the presence of physiological concentrations of sodium and potassium ions was demonstrated and is key to the success of the proposed electroanalytical technique. The ability to measure directly in an aqueous system is an extremely valuable Phase l finding, as it keeps the detection of lithium in blood as simple as possible. The Phase II Specific Aims encompass optimization of the detection method, development of the microanalysis system, design and fabrication of an integrated Instrument, and laboratory sample evaluation in collaboration with The Massachusetts General Hospital Bipolar Clinic and Research Program.

项目摘要/摘要 锂血液水平的电化学家居监测系统 碳酸锂形式的锂是双极的重要药理治疗选择 障碍（BD）和其他条件。但是，锂的治疗范围狭窄 使用需要仔细监测患者的锂血液水平，尤其是在开始 治疗。当前的监测技术不方便且昂贵，需要进行临床分析 实验室。没有可用于血液锂的家庭测量的商业可用系统。 该程序的目的是开发包装的基于电化学的检测方法 进入便携式，独立，易于使用的仪器/系统，用于分析锂。这将是 适合在家庭环境中用于监测BD患者或其他患者的锂水平 利用锂处理。它也可以在办公室期间在临床医生办公室中进行实时阅读 访问。拟议技术的主要优点是电化学技术可以是 包装成用于自动操作的工具，使其非常便宜，并且 与其他基于实验室的分析技术相比，方便。最后的家庭锂显示器 产品将具有与家用葡萄糖监测仪相同的易用性，并为临床医生提供现实 最佳和具有成本效益的患者治疗所需的时间锂测量值。这 仪器将在几分钟之内可靠，准确地确定锂的浓度 患者通过手指刺提供血液样本，结果将实时报告给临床医生。 频繁的家庭监控既可以用来调节剂量，又可以确认患者正在服用 规定的调解。这将改善患者护理并降低医疗费用。 在第一阶段，Giner，Inc。开发了传感器设计配置，具有高性能电极 材料和操作条件，表明对电化学检测的可行性 锂离子（LI+）在水性培养基中的相关范围（0.2-3 mm），包括生理液 模拟。在存在生理浓度的情况下测量锂离子浓度的能力 证明了钠和钾离子的含量，这是提议成功的关键 电分析技术。在水系统中直接测量的能力是极其 有价值的相位发现，因为它可以使血液中锂的检测尽可能简单。 II期 具体目的包括检测方法的优化，开发微分析 集成仪器的系统，设计和制造以及实验室样本评估 与马萨诸塞州综合医院双极诊所和研究计划合作。