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

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.