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.

项目总结/摘要 电化学家庭锂血浓度监测系统 碳酸锂形式的锂是双极型糖尿病的重要药理学治疗选择。 疾病（BD）和其他病症。然而，锂具有狭窄的治疗范围， 使用需要仔细监测患者的锂血液水平，特别是在开始给药期间。 治疗目前的监测技术是不方便和昂贵的，需要临床分析， 实验室目前还没有用于家庭测量血锂的市售系统。 该计划的目标是开发基于电化学的检测方法， 转换成便携式、独立、易于使用的仪器/系统，用于锂的分析。将 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。它也可以用于临床医生的办公室，在办公期间进行实时读数 探访所提出的技术的一个主要优点是，电化学技术可以被 包装成仪器，用于在家中自动操作，这使得它们非常便宜， 与其他基于实验室的分析技术相比，最后的家用锂监测器 产品将具有与家用血糖监测仪相同的易用性，并为临床医生提供真实的- 时间锂测量所需的最佳和具有成本效益的治疗的病人。这 仪器将在几分钟内可靠和准确地确定锂浓度后， 患者通过手指针刺提供血液样本，结果将真实的及时报告给临床医生。 频繁的家庭监测可用于调节剂量并确认患者正在服用 规定的调解。这将改善患者护理并降低医疗成本。 在第一阶段，Giner，Inc.开发的传感器设计配置，具有高性能电极 材料和操作条件，证明了电化学检测的可行性， 在水性介质（包括生理流体）中锂离子（Li+）的相关范围（0.2-3 mM 模拟物。在生理浓度存在下测量锂离子浓度的能力 的钠和钾离子的证明，是成功的关键，提出了 电分析技术直接在含水体系中测量的能力是一个极其重要的因素。 这是一项有价值的I期研究发现，因为它使血液中锂的检测尽可能简单。II期 具体目标包括优化检测方法，发展微量分析 系统、综合仪器的设计和制造以及实验室样品评价 与马萨诸塞州总医院双极临床和研究项目合作。