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

该小型企业创新研究(SBIR)第二阶段项目旨在开发一种无线、可植入针头的微型(0.5 x 0.5 x 5 mm)传感器，用于连续血糖监测，具有内部自校准功能，最终消除了频繁的外部手指刺伤的需要。作为第一阶段项目的一部分，已经制定了内部校准程序，其概念验证？已经在植入式葡萄糖传感器单元上得到证实，该传感器在猪血清中运行了3周。沿着这些思路，还开发了与可植入单元可操作的通信的接近通信器(类似腕表的单元)。第二阶段旨在通过在活体环境(大鼠模型)中展示其在活体环境(大鼠模型)中的有效性以及邻近通信器单元的进步来进一步增强该校准例程的可靠性，以便与能够实时数据处理和实施内部校准例程的智能手机建立双向通信。在第二阶段结束时，预计自校准血糖监测平台的开发活动将完成，从而使其离临床前动物研究市场(Biorasis Inc.的第一个市场)的商业化更近一步。考虑到鉴于糖尿病患者的数量不断增加，迫切需要连续的血糖监测设备，该项目的广泛/商业影响是巨大的。植入式葡萄糖传感器提供了最少的用户干预，提供了一个可行的替代方案，尽管它们是独立于用户的？由于需要通过痛苦的手指刺痛进行频繁的外部校准，自然常常受到破坏。拟议的项目将导致一个真正独立于用户的？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，也可以用于其他疾病的管理(如肥胖和心血管并发症)，将为我们在康涅狄格州和邻近地区的医疗器械、无线通信和生物传感器领域的新工作铺平道路。该项目将在康涅狄格大学(UConn)技术孵化计划(TIP)中与康涅狄格大学的合作者合作进行。这种产业/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工业竞争力。

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.