Development and Validation of Efficient Algorithms for Real-Time Glucose Monitoring on a Multi-Sensor Integrated Platform

Integrated Medical Sensors, Irvine CA

Investigators

Abstract

The long-term goal of this project is to develop a scalable, user-friendly, and affordable continuous glucose monitoring (CGM) system to improve 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 several advantages, including extreme miniaturization, enhanced signal-to-noise ratio (SNR), multi-sensor redundancy for better accuracy, and on-chip temperature calibration for improved reliability. The system leverages scalable semiconductor and flexible hybrid electronics manufacturing methods, increasing lot sizes by over 1000x compared to current CGMs, potentially simplifying factory calibration and reducing costs. It also provides superior performance, such as improved hypoglycemia accuracy, and usability benefits with a 5x smaller and 50% lighter transmitter compared to the Libre 3 CGM, allowing for a gentler skin adhesive that reduces irritation. IMS has demonstrated the core platform's functionality in humans through a First-In-Human (FIH) feasibility study presented at ADA 2023 and a second human study at ATTD 2024, and ADA 2025 showcasing multi-day sensor operation. This shows the significance of the platform for further NIH support. Currently, retrospective data processing is used to generate glucose readings from the device data. The Objective of this grant is to optimize these data processing algorithms to generate glucose readings from the IMS CGM while eliminating noise (de-noising) and combining multi-sensor data (fusion). IMS has shown that this is feasible. Upon demonstrating in vitro feasibility in Phase I, these algorithms will be tested in pre-clinical and clinical studies in Phase II. The project team includes the original inventors from the California Institute of Technology (Dr. Nazari, Dr. Rahman, and Mr. Sencan), along with seasoned researchers and industry experts such as Bill Van Antwerp (former CSO of Medtronic MiniMed), quality and IP expert John Heithaus, commercialization expert Paul Strasma (former CEO of Capillary Biomedical), clinical expert Dr. Anne Peters (Head of USC Diabetes Clinics), and biosensor expert Dr. Natalie Wisniewski (former CTO of Profusa, Inc.). The team will mentor Ms. Narges Honarvar Nazari in her transition from academic research into medical devices industry and entrepreneurship.