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

在家检测血钠以治疗尿崩症

• 批准号: 10395189
• 负责人: Avni A Argun
• 金额: $ 25.96万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10395189
• 关键词: Affect; Benchmarking; Biological Assay; Blood; Blood Glucose; Blood Glucose Self-Monitoring; Blood Tests; Blood Volume; Blood specimen; Body Water; CLIA certified; Calibration; Caring; Central Diabetes Insipidus; Cessation of life; Child; Childhood diabetes; Clinical; Clinical Chemistry; Complex; Complications of Diabetes Mellitus; Consultations; Dangerousness; Data; Decision Making; Dehydration; Detection; Development; Diabetes Insipidus; Disease Management; Drops; Electrolytes; Emergency department visit; Formulation; Foundations; Goals; Health Professional; Home; Hormones; Hospitalization; Hospitals; Hour; Hydration status; Hypernatremia; Hyponatremia; Impairment; Individual; Insulin; Intake; Ion-Selective Electrodes; Label; Laboratories; Lead; Life; Liquid substance; Measurement; Measures; Membrane; Methodology; Methods; Monitor; Nervous System Trauma; Neurosecretory Systems; Normal Range; Organ; Patients; Pediatric Hospitals; Performance; Pharmacology; Phase; Philadelphia; Phosphate Buffer; Plasma; Population; Process; Quality of life; Rare Diseases; Reagent; Regulation; Reporting; Saline; Sampling; Schools; Seizures; Sodium; Specificity; Speed; Techniques; Testing; Thirst; Time; Travel; Validation; Vasopressins; Vendor; Venous; Visit; Wood material; Work; adipsia; base; cost; cost effective; design; diabetes management; experience; home test; hormone deficiency; instrument; operation; overtreatment; point of care; portability; prevent; programs; prototype; rapid test; sensor; sodium ion; success; test strip; treatment optimization; voltage

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.

项目概要/摘要 中枢性尿崩症 (DI) 是由加压素激素缺乏引起的一种罕见疾病， 每 25,000 人中就有 1 人缺乏加压素，钠水平很快就会升高，并且会出现这种情况。 容易发生危险的脱水，导致频繁住院。 尿崩症的治疗包括 DI 治疗不足时，进行药物加压素替代并仔细调节液体摄入量。 导致高钠血症（高血钠水平）和脱水，过度治疗导致低钠血症（低血钠） 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 损害，甚至死亡是最佳 DI 管理和预防的最大障碍。 并发症和住院治疗，是缺乏现成、快速、准确的血钠 患有严重尿崩症的人经常去医院，并且钠水平恢复延迟。 由于无法进行快速检测，DI 管理不善会导致可预防的并发症。 因此，目标儿童 DI 人群对家庭钠监测的需求也未得到满足 作为专为家庭使用而设计和批准的钠监测仪的令人兴奋的潜力。 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 体积远高于指尖采血量，对于家庭血钠常规检测不实用。 该计划的总体目标是开发一种家用、经济高效的传感器产品，能够准确测量 血钠定量血液钠水平的快速而简单的电化学测试满足 Giner 将开发手持式血钠监测仪并进行演示。 使用小容量指尖血量 (< 100 µl) 在宽线性范围内定量检测钠 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电极 (ISE)。 类似于血糖检测的快速（单步）、无标记和无试剂操作的方法 第一阶段可行性计划的目标是： 1) 开发改良的钠测试条。 钠离子选择性膜（ISM）配方；2）样品处理技术的开发和 用于现场护理操作的传感器校准；以及 3) 调整传感器以进行血液分析、血液测试 血浆样本，并根据标准临床化学方法进行性能基准测试。