SBIR Phase I: A miniaturized, low-cost, implantable wireless glucose sensor technology for Diabetes management

该项目更广泛的影响/商业潜力是开发一种新型的实时生物医学传感平台，可以彻底改变个人健康和临床研究。慢性疾病（心血管、糖尿病等）是美国死亡和残疾的主要原因。仅糖尿病就影响了美国超过2900万人，导致每年2450亿美元的医疗保健费用。疾病管理需要一个长期和可靠的身体代谢物监测系统。所提出的无线传感技术将通过使用利用可扩展微电子制造技术的新型mm尺寸集成系统提供组织间液（ISF）成分的低成本、微创、皮下传感来解决这一需求。拟议的开发工作将允许将该技术用于医学研究（药物/疾病）和连接或数字健康中的无线传感应用。目前，糖尿病患者依赖于疼痛和离散的手指针刺测量或昂贵的（4000美元/年）和短寿命（7天）的经皮设备进行葡萄糖监测。低成本（500美元/年），无痛，可靠和准确的血糖监测仪将通过提供适合不同患者以及临床医生和研究人员的解决方案而产生广泛的商业影响。拟议的项目将导致植入式葡萄糖传感器的真正“用户独立”操作，从而带来竞争市场优势和创造就业机会。该小型企业创新研究第一阶段项目旨在开发一种无线单片传感平台，该平台将传感，控制，自主供电和通信结合在一个mm尺寸的微芯片植入物上。极小的器械尺寸最大限度地减少了异物反应，并导致稳定的传感器组织，与当前器械相比，允许更长时间和稳定的操作。该器件采用行业标准技术进行无线操作，简化了系统开发和集成。传感器在半导体平台上制造，形成完全集成的系统，避免了昂贵的布线和封装。半导体技术的可扩展性增强了可制造性，降低了批量生产的单位成本，并确保了大批量生产的可用性。第一阶段旨在开发针形形式的集成传感器解决方案，并提供适当的插入/拔出装置作为概念验证，以允许进行小规模动物研究来表征系统的功能。还提议测试使用所提议的系统实现性能目标（体外MARD、比最先进的CGM器械更长的稳定体内操作、体内MARD的确定）的可行性。在成功的可行性阶段之后，我们将优化系统性能，并在第二阶段为商业化所需的临床试验提交FDA IDE申请。

The broader impact/commercial potential of this project is the development of a novel, real-time biomedical sensing platform that can revolutionize personal health and clinical research. Chronic diseases (cardiovascular, diabetes, etc.) are the leading causes of death and disability in US. Diabetes alone affects more than 29 million people in US, resulting in $245B annual health care cost. Disease management requires a long-term and reliable body metabolite monitoring system. The proposed wireless sensing technology will address this need by providing low-cost, minimally invasive, subdermal sensing of interstitial fluid (ISF) constituents using a novel mm-size integrated system utilizing scalable microelectronics fabrication technology. The proposed development effort will allow the use of this technology to wireless sensing applications in medical research (drugs/diseases) and connected or digital health. Currently, diabetes patients rely on painful and discrete fingerstick measurements or expensive ($4k/year) and short-lived (7 days) transcutaneous devices for glucose monitoring. A low-cost ($500/year), pain free, reliable and accurate glucose monitor will have a broad commercial impact by providing a solution suitable to a diverse set of patients as well as clinicians and researchers. The proposed project will result in a truly "user-independent" operation of implantable glucose sensors, rendering competitive market edge and job creation. This Small Business Innovation Research Phase I project is intended to develop a wireless monolithic sensing platform that combines sensing, control, autonomous powering, and communication on a single mm-size microchip implant. The extremely small device size minimizes foreign body response and results in a stable sensor-tissue, allowing for much longer and stable operation compared to current devices. The device utilizes wireless operation using industry standard technologies, simplifying system development and integration. The sensor is fabricated on the semiconductor platform to form a fully integrated system and avoid expensive wiring and packaging. The scalable nature of the semiconductor technology enhances manufacturability, reduces unit cost in volume production, and ensures the availability of high volume manufacturing. Phase-I seeks to develop the integrated sensor solution in a needle-shape form and provide appropriate insertion/extraction device as a proof-of-concept to allow for a small-scale animal study to characterize the functionality of the system. It is also proposed to test the feasibility of achieving performance goals (in-vitro MARD, stable in-vivo operation longer than state-of-the-art CGM devices, determination of in-vivo MARD) using the proposed system. After successful feasibility phase, we will optimize the system performance and move to FDA IDE filing for clinical trials needed for commercialization, during Phase II.