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

 描述(申请人提供)：这笔STTR赠款旨在通过开发一种实时血糖监测设备来改善新生儿血糖稳态(GH)的监测，从而减少反复针刺引起的疼痛。这项创新利用了STTR合作伙伴乔治华盛顿大学(GWU)发明的基于微针的贴片实验室平台。GH通常通过脚跟棒进行血液检测，或者将血液送到实验室进行确认，但与实际水平的差异可能高达10-20毫克/分升。有生长激素风险的婴儿可能需要每3小时或每天8次进行血糖测试，这需要在脚后跟上扎一针以获取血液样本，然后使用床边试剂试纸血糖分析仪。新生儿缺乏实时血糖监测是减少样本采集量和针刺的一个主要未得到满足的需求。一种可弯曲、可伸展的微流控贴片用于使用NICU婴儿的间质液体(或血液)实时监测血糖，这将是第一个将疼痛和针刺次数减少到每24小时一次的产品。这款生物传感器将通过Zansors移动健康IT云系统与智能手机应用程序安全通信。GWU的原理验证数据显示在《自然》杂志2013年1月的《科学报告》中，报告了一种通过液态金属互连在柔性基板上集成半导体/CMOS传感器和电子与微流体的微型贴片实验室技术。Zansors‘s 拥有一个创新的远程医疗系统，具有加密和HIPAA合规性，可以集成到这一提议的设备中。第一阶段假设：一个可弯曲、可伸展的传感器平台集成了CMOS电化学传感器/电子芯片、微流体通道和可伸展电互连的混合体，可以使用更少的间质液体样本和更少的针刺，并提供实时传感器，可以在不引人注目的情况下长期(24小时)连续监测GH，然后将安全的无线数据发送到符合HIPAA标准的远程医疗移动健康云系统。具体目标1：开发一种可穿戴的微针贴片实验室。采用COTS技术设计了电化学葡萄糖传感器和CMOS电子器件；采用软光刻技术完成了PDMS微流控器件的设计和制作。具体目标2：适配和校准算法，以实时从流体数据计算生长激素，并开发移动应用程序来收集、处理、分析和存储来自设备的数据，并与远程医疗和数字健康云系统进行通信。具体目标3：使用葡萄糖溶液，展示一种用于血糖监测的可弯曲、可伸缩封装的CMOS微流控系统。新生儿血糖监测市场是更大的连续血糖监测(CGM)市场的一个子集。到2020年，CGM将增长到5.68亿美元。

 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.