SBIR Phase II: Self Calibrating, Wireless, Needle Implantable Sensor for Continuous Glucose Monitoring

SBIR 第二阶段：用于连续血糖监测的自校准无线针植入传感器

• 批准号: 1230148
• 负责人: Michail Kastellorizios
• 金额: $ 48.64万
• 依托单位: Biorasis Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1230148&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Self; Calibrating

This Small Business Innovation Research (SBIR) Phase II project aims to develop a wireless, needle implantable miniaturized (0.5 x 0.5 x 5 mm) sensor for continuous glucose monitoring, with provisions for internal self-calibration that ultimately eliminates the need for frequent, external finger-pricking. As part of Phase I project, the internal calibration routine has been developed and its ?proof-of-concept? has been demonstrated on an implantable glucose sensor unit operating in porcine serum for a period of 3 weeks. Along these lines, a proximity communicator (wrist-watch like unit) has also been developed which is in operable communication with the implantable unit. Phase II aims to further enhance the reliability of this calibration routine by demonstrating its efficacy in an in vivo environment (rat model) along with advancement of the proximity communicator unit in order to establish a two-way communication with a smartphone capable of real time data processing and implementation of the internal calibration routine. At the end of Phase-II, the completion of developmental activities for the self-calibrating glucose monitoring platform is envisioned, thereby, bringing it a step closer to commercialization in the pre-clinical animal research market (first market of Biorasis Inc.) The broader/commercial impacts of this project are enormous considering that there is an urgent need for continuous glucose monitoring devices in view of the growing number of diabetic patients. Implantable glucose sensors that afford minimal user intervention present a viable alternative, although their ?user-independent? nature is often undermined by the need for frequent external calibration via painful finger-pricking. The proposed project will result in a truly ?user-independent? operation of implantable glucose sensors. The successful implementation of such an advanced glucose monitoring technology, which can also be adapted for the management of other disorders (such as obesity and cardiovascular complications) will pave way for new jobs in our Stare of Connecticut and neighboring regions in the sectors medical devices, wireless communication and biosensors. The project will be performed in the University of Connecticut (UConn) Technology Incubation Program (TIP) in partnership with UConn collaborators. This industrial/academic collaboration provides training for the graduate and undergraduate students in the field of biosensors, optical powering, chip design and wireless data communication and will motivate them to US industrial competitiveness.

该小型企业创新研究（SBIR）第二阶段项目旨在开发一种用于连续葡萄糖监测的无线针植入式微型（0.5 x 0.5 x 5 mm）传感器，并提供内部自校准，最终消除频繁的外部手指穿刺的需要。 作为第一阶段项目的一部分，内部校准程序已经开发，其？概念验证已经在猪血清中操作的可植入葡萄糖传感器单元上证明了3周的时间。 沿着这些路线，还开发了与可植入单元可操作地通信的接近通信器（手表状单元）。 阶段II旨在通过证明其在体内环境（大鼠模型）中的功效来进一步增强该校准例程的可靠性，沿着接近通信器单元的进步，以便与能够进行真实的时间数据处理和内部校准例程的实施的智能手机建立双向通信。 在第二阶段结束时，预计将完成自校准葡萄糖监测平台的开发活动，从而使其更接近临床前动物研究市场（Biorasis Inc.的第一个市场）的商业化。考虑到糖尿病患者数量不断增加，对持续葡萄糖监测设备的需求迫切，该项目的广泛/商业影响巨大。 植入式葡萄糖传感器，提供最低限度的用户干预提出了一个可行的替代方案，虽然他们？用户独立？由于需要通过痛苦的手指针刺进行频繁的外部校准，自然界经常受到破坏。该项目将产生真正的？用户独立？植入式葡萄糖传感器的操作。这种先进的血糖监测技术的成功实施，也可以适用于其他疾病（例如肥胖和心血管并发症）的管理，将为康涅狄格州和邻近地区医疗设备、无线领域的新就业机会铺平道路。通信和生物传感器。该项目将在康涅狄格大学（UConn）技术孵化计划（TIP）中与UConn合作者合作进行。 这种工业/学术合作为研究生和本科生提供生物传感器，光学供电，芯片设计和无线数据通信领域的培训，并将激励他们提高美国的工业竞争力。