A miniaturized and flexible continuous glucose monitoring platform using scalable semiconductor manufacturing

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Integrated Medical Sensors Inc. a $922,875 Project Grant on August 25, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop a miniaturized and flexible continuous glucose monitoring platform using scalable semiconductor manufacturing.

Integrated Medical Sensors is designing an optimized continuous glucose monitoring system called GlucoSoft that expands the use of flexible electronics to create a first-in-class flexible band-aid transmitter. The work builds on the recipient's prior demonstration of a miniaturized electrochemical analyte sensing platform using application-specific integrated circuit technology based on complementary metal-oxide-semiconductor technology. The system achieves extreme miniaturization, improved signal-to-noise ratio, multi-sensor redundancy for enhanced accuracy, and on-chip temperature calibration. Manufacturing methods increase lot sizes by over 1000 times compared to current continuous glucose monitoring systems, simplify factory calibration, and reduce costs. The transmitter is 5 times smaller and 50 percent lighter than comparable commercial systems. Human feasibility studies have demonstrated function and multi-day sensor operation; a 15-day operational study is accepted for presentation at the American Diabetes Association 2025 conference.

Performance takes place in Irvine, California, with a period of performance ending July 31, 2028. Integrated Medical Sensors is a minority-owned, small disadvantaged business.

Abstract

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) and multi-sensor redundancy for better accuracy, and on-chip temperature calibration for enhanced accuracy and reliability. The system employs highly scalable semiconductor and flexible hybrid electronics manufacturing methods, increasing lot sizes by over 1000X compared to current cgms, simplifying factory calibration, and reducing costs. The system provides better performance (e.g., better hypoglycemia accuracy) and better usability (5X smaller and 50% lighter transmitter as compared to state-of-the-art libre 3 CGM). We have demonstrated the function of the IMS CGM in humans through a first-in-human (FIH) feasibility study presented at ADA 2023. We have also presented data from a second human study at attd 2024 demonstrating multi-day sensor operation. Recently, we verified the feasibility of the system's 15-day operation in an ongoing human study (accepted for presentation at ADA 2025). Our objective in this grant is to optimize the design by expanding the use of flexible electronics to create a first-in-class flexible band-aid transmitter, as requested by clinical experts and users, to improve usability and adoption. 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 skin-friendly CGM while decreasing costs through a unified fabrication scheme using flexible electronics for both the minimally invasive percutaneous sensing filament (with embedded CMOS chip or ASIC) 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 specific aims of this grant are based on requirements by strategic partners, investors, and the FDA to establish a GMP manufacturing that can be used to generate the large number of sensors required for larger clinical trials leading to the pivotal trial. The team includes the original inventors of the core technology from the california institute of technology (DR. Nazari, DR. Rahman), 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 experts (DR. Anne peters, MD and 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.).