At-home Testing of Blood Sodium for Management of Diabetes Insipidus

项目概要/摘要 中枢性尿崩症（DI）是由加压素缺乏引起的一种罕见疾病， 每25，000人中就有1人受到影响。缺乏加压素的人很快就会有高钠水平， 容易脱水，导致频繁住院。DI的治疗包括 药物加压素替代和仔细调节液体摄入。虽然DI治疗不足， 引起高钠血症（高血钠水平）和脱水，过度治疗引起低钠血症（低 血钠水平），这可能导致癫痫发作，永久性神经损伤，多系统器官 损伤，甚至死亡。最大的障碍是最佳的DI管理， 并发症和住院，是缺乏现成的，快速，准确的血钠 测量.患有严重DI的个体经常前往医院，钠水平恢复延迟 由于快速检测的不可用性，导致了由于DI的管理不善而引起的可预防的并发症。有 因此，在目标儿科DI人群中，对家庭钠监测的需求也大量未得到满足 作为一个令人兴奋的潜力，钠监测器专门设计和批准用于家庭使用。 目前可用的血液电解质分析仪是昂贵的实验室仪器，接受静脉血， 体积比手指针刺高得多，并且对于血液钠的家庭常规测试是不实用的。的 该计划的总体目标是开发一种能够准确测量的家用、具有成本效益的传感器产品 血钠一种快速简单的电化学测试来量化血液中的钠水平， 这是DI护理的关键需求。Giner将开发一种手持式血钠监测仪， 使用少量手指针刺血容量（<100 µ l）定量检测钠，在宽线性范围内 范围为100 - 360 mM（正常范围为138 - 146 mM）。Giner将使用改良的离子选择性电极（ISE） 一种允许快速（单步）、无标记和无试剂操作的方法，类似于血糖分析 test.第一阶段可行性计划的目的是：1）开发一种钠测试条， 钠离子选择性膜（ISM）配方; 2）开发样品处理技术， 用于护理点操作的传感器校准;以及3）使传感器适于血液分析，用血液测试 血浆样品，并对照标准临床化学方法学进行基准性能测试。

PROJECT SUMMARY/ABSTRACT Central diabetes insipidus (DI), caused by a deficiency of the hormone vasopressin, is a rare disease that affects 1 in 25,000 individuals. Individuals who lack vasopressin can quickly have high sodium levels and are vulnerable to dangerous dehydration, leading to frequent hospitalizations. Treatment for DI includes pharmacologic vasopressin replacement and careful regulation of fluid intake. While under-treatment of DI causes hypernatremia (high blood sodium levels) and dehydration, over-treatment causes hyponatremia (low blood sodium levels), which can lead to seizures, permanent neurological injury, multi-system organ impairment, and even death. The most substantial barrier to optimal DI management, and to preventing complications and hospitalizations, is the lack of readily available, quick, and accurate blood sodium measurements. Individuals with severe DI travel to hospitals frequently and the delay in return of sodium levels due to unavailability of rapid tests leads to preventable complications from mismanagement of DI. There is therefore a substantial unmet need for in-home sodium monitoring in the target pediatric DI population as well as an exciting potential of a sodium monitor specifically designed and approved for in-home use. Currently available blood electrolyte analyzers are expensive laboratory instruments, accept venous blood at volumes much higher than fingersticks, and are not practical for routine in home testing for blood sodium. The overall goal of this program is to develop an in-home, cost-effective sensor product that accurately measures blood sodium. A rapid and simple electrochemical test to quantify the blood levels of sodium meets a critical need within DI care. Giner will develop a handheld blood sodium monitor and demonstrate quantitative detection of sodium using small volume fingerstick blood volumes (< 100 µl), within a broad linear range of 100-360 mM (normal range is 138-146 mM). Giner will utilize a modified ion-selective electrode (ISE) approach that will allow for rapid (single-step), label-free, and reagent-free operation similar to a blood glucose test. The Aims of the Phase I feasibility program are: 1) Development of a sodium test strip modified with sodium ion selective membrane (ISM) formulations; 2) Development of sample handling techniques and sensor calibration for point-of-care operation; and 3) Adapting sensor for blood analysis, testing with blood plasma samples, and benchmarking performance against the standard clinical chemistry methodologies.