Lab-on-a-patch for neonates to monitor real-time glucose and reduce needle pain

新生儿实验室贴片可监测实时血糖并减轻针刺疼痛

• 批准号: 9131895
• 负责人: Zhenyu Li
• 金额: $ 22.49万
• 依托单位: ZANSORS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9131895
• 关键词: Algorithms; Anemia; Area; Award; Biosensor; Blood; Blood Glucose; Blood Tests; Blood Transfusion; Blood specimen; Car Phone; Cellular Phone; Clinical; Collaborations; Collection; Consumption; Data; Detection; Device Designs; Devices; Electrolytes; Electronics; Frequencies; Glucose; Goals; Grant; Health; Health Insurance Portability and Accountability Act; Health Personnel; Heel; Hour; Hybrids; Hypoglycemia; Infant; Intercellular Fluid; Laboratories; Legal patent; Licensing; Liquid substance; Marketing; Metals; Microfluidic Microchips; Microfluidics; Monitor; Nature; Needles; Neonatal; Neonatal Intensive Care Units; Nurseries; Pain; Phase; Premature Infant; Privacy; Process; Reporting; Research; Risk; Safety; Sampling; Secure; Semiconductors; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Stimulus; System; Technology; Telemedicine; Testing; Time; Transfusion; Universities; Variant; Washington; Wireless Technology; Withdrawal; Work; base; blood glucose regulation; commercialization; cost efficient; dashboard; design; digital; encryption; evidence base; experience; flexibility; glucose monitor; glucose sensor; improved; innovation; lithography; mHealth; micro-total analysis system; miniaturize; mobile application; monitoring device; neonatal patient; neonate; pediatric patients; premature; public health relevance; rapid diagnosis; reagent testing; sensor; subcutaneous; technological innovation; type I diabetic

 DESCRIPTION (provided by applicant): This STTR grant is aimed to reduce pain from repeated needle pricks by improving the monitoring of glucose homeostasis (GH) in neonates by developing a real-time glucose monitoring device. The innovation utilizes a micro-needle based lab-on-a-patch platform invented by STTR partner, George Washington University (GWU). GH is usually monitored by blood test via a heel stick, or blood is sent to the lab for confirmation but variation from actual levels may be as much as 10-20 mg/dL. Infants at risk for GH may require glucose testing every three hours or 8 times/day necessitating a needle prick on the heel to obtain a blood sample and then using a bedside reagent test-strip glucose analyzers. The lack of real-time glucose monitors in neonates is a major unmet need for reducing sample volume collection and needle pricks. A bendable, stretchable microfluidic patch for real-time monitoring of glucose using interstitial fluids (or blood) in NICU infants will be th first product for reducing pain and the frequency of needle pricks to once every 24 hours. This biosensor will securely communicate with a smartphone app via Zansors mobile health IT cloud system. Proof-of-principle data by GWU was shown in Nature's Scientific Reports Jan. 2013 reporting a miniaturized lab-on-a-patch technology integrating semiconductor/CMOS sensors and electronics with microfluidics on a flexible substrate via liquid metal interconnects. Zansors' possesses an innovative telemedicine system with encryption and HIPAA compliance that can be integrated to this proposed device. Phase I Hypothesis: A bendable, stretchable sensor platform that integrates a hybrid of CMOS electrochemical sensors/electronics chip, microfluidic channels, and stretchable electrical interconnects may use less interstitial fluid sample and less needle pricks, and offer a real-time sensor that monitors GH and continuously for long terms (24 hours) unobtrusively and then send the secure wireless data to a HIPAA-compliant telemedicine mobile health cloud system. Specific Aim 1: Develop a wearable lab-on-a-patch with micro-needle. Design electrochemical glucose sensors and CMOS electronics in COTS technology; Finish the PDMS microfluidic device design and fabrication with soft lithography. Specific Aim 2: Adapt and calibrate the algorithm to compute GH from fluid data in real-time, and develop a mobile app to collect, process, analyze and store data from the device and communicate with a telemedicine and digital health cloud system. Specific Aim 3: Using glucose solutions, demonstrate a proof-of-principle packaged bendable, stretchable CMOS/Microfluidic system for glucose monitoring. The neonatal glucose monitor market is a subset of the larger continuous glucose monitoring (CGM) market. CGM is set to grow to $568 million by 2020.

 描述（由适用提供）：通过开发一种实时的葡萄糖监测装置，通过改善新生儿中葡萄糖稳态（GH）的监测来减轻重复的针刺疼痛。该创新利用了由STTR合作伙伴George Washington University（GWU）引入的基于微针的实验室的实验室平台。 GH通常通过脚跟棒通过血液检查监测，或将血液发送到实验室以进行确认，但实际水平的变化可能高达10-20 mg/dl。有GH风险的婴儿可能需要每三个小时或8次每天进行葡萄糖测试，以获取脚跟上的针刺以获取血液样本，然后使用床头试剂试剂测试 - 葡萄糖分析仪。新生儿缺乏实时葡萄糖监测器是减少样品体积收集和针刺的主要未满足需求。可弯曲的，可伸展的微流体贴片，用于对NICU婴儿中的间质氟（或血液）实时监测葡萄糖的实时监测，这将是第一个减少疼痛和针刺频率每24小时的产品。该生物传感器将通过Zansors Mobile Health IT Cloud System与智能手机应用程序进行安全通信。 GWU的原理数据证明在2013年1月在自然的科学报告中显示了一项小型实验室，将半导体/CMOS传感器和电子设备与液体金属互连的柔性基板上的微流体集成在一起。 Zansors的 具有具有加密和HIPAA合规性的创新远程医疗系统，可以集成到该提议的设备中。 Phase I Hypothesis: A bendable, stretchable sensor platform that integrates a hybrid of CMOS electronic sensors/electronics chip, microfluidic channels, and stretchable electrical interconnects may use less interstitial fluid sample and less needle pricks, and offer a real-time sensor that monitors GH and continuously for long terms (24 hours) unobtrusively and then send the secure wireless data to a HIPAA-compliant远程医疗移动健康云系统。特定目标1：用微针开发可穿戴的实验室。在COTS技术中设计电子葡萄糖传感器和CMOS电子设备；用软岩性摄影完成PDMS微流体设备设计和制造。具体目标2：调整和校准算法实时计算流体数据的GH，并开发一个移动应用程序来收集，处理，分析和存储从设备中的数据，并与远程医疗和数字健康云系统进行通信。特定目标3：使用葡萄糖溶液，展示了原本包装的可弯曲，可伸缩的CMOS/微流体系统进行葡萄糖监测。新生儿葡萄糖监测器市场是较大连续葡萄糖监测（CGM）市场的子集。到2020年，CGM将增长到5.68亿美元。