A Miniaturized and Flexible Continuous Glucose Monitoring Platform

PROJECT SUMMARY The long-term goal of this project is to develop a scalable, user-friendly, and affordable continuous glucose monitoring (CGM) system for better diabetes management. IMS has created the world's smallest electrochemical analyte sensing platform using an application- specific integrated circuit (ASIC) based on Complementary Metal-Oxide Semiconductor (CMOS) technology. This design offers unique advantages, including extreme miniaturization, improved signal-to-noise ratio (SNR) for better hypoglycemia accuracy, and on-chip temperature calibration for enhanced accuracy and reliability. The system employs highly scalable semiconductor and flexible electronics manufacturing methods, increasing lot sizes by over 1000 times compared to current CGMs, simplifying factory calibration, and reducing costs to improve affordability and broaden usage. We demonstrated the core IMS CGM platform's function in humans through a First-In-Human (FIH) feasibility study presented at ADA 2023. Recently, we verified the feasibility of the system’s 14-day operation in an ongoing human study. Our objective in this grant is to optimize the design by expanding the use of flexible electronics to create a first-in-class "band-aid" transmitter, as requested by clinical experts and users, to improve usability and acceptance among minority populations. This new flexible platform is named “GlucoSoft.” This work is significant as it will enable a fundamental improvement in CGM usability by creating the first truly flexible "band-aid" transmitter and decreasing costs through a unified fabrication scheme using flexible electronics for both the in vivo sensor and the skin-worn transmitter. This will be the first ever CGM with extremely thin and flexible design, hence the reference to “band aid”. The team includes the original inventors of the core technology from the California Institute of Technology (Dr. Nazari, Dr. Rahman, Mr. Sencan), a seasoned researcher in electrochemical sensor technology (Bill Van Antwerp, former CSO of Medtronic MiniMed), regulatory and IP expert (John Heithaus, JD), commercialization expert (Mr. Paul Strasma, former CEO of Capillary Biomedical), clinical expert (Dr. Alan Marcus, MD; former Chief Medical Officer of Medtronic Diabetes), and biosensors and biomaterials expert (Dr. Natalie Wisniewski, Ph.D., former CTO of Profusa, Inc.).