115-LB: Human Feasibility of a Semiconductor-Based Continuous Glucose Monitoring System

CGMs have advanced significantly in recent years. However, accuracy, response speed, size, and cost improvements are still required for better adoption and outcomes. We combine semiconductor and nano technologies to create an extremely miniaturized (5x smaller than a rice grain) electrochemical sensing platform, IMSense. It is user-insertable under the skin using a custom injector and is also user-removable. It has a multi-sensor array and sends multiplexed data to an external transmitter which processes and relays it to a reader via BLE. It also has a reference sensor to monitor the system status. We previously validated the system in the lab and in animals. Recently, a study in a cohort of 10 persons (with and without diabetes) was approved. In the study, fingerprick readings from each subject were taken every 15 minutes for one day (6 hours) using a Contour SMBG meter (reference) and compared against readings from IMSense, Dexcom, and Abbott CGMs. The results show that the IMSense tracks the reference precisely. A response curve in a person with diabetes and the Clarke error grid for the study are shown (the correlation coefficient between IMS and reference is 93%). The three glucose sensors and the reference sensor on an IMSense device are used to formulate an accurate combined signal. These results demonstrate the human feasibility of monitoring glucose using an integrated sensor array on a single semiconductor device.