Miniaturization is key to improve integration of minimally invasive CGM sensors with local tissue. The better is this integration, the lesser is the foreign body response, the faster and more accurate is the sensor, and the better suited it is for glucose monitoring. IMS has used semiconductor technology to develop world’s first fully-integrated CGM sensor that is also the smallest glucose sensor developed to date. The integrated CGM includes an electrochemical glucose oxidase based sensor, a small potentiostat, signal processing circuit, and wireless powering and communication capability. The sensor is powered by and communicates with a wearable wireless transmitter using RFID. The transmitter communicates with a smartphone, and smart insulin pumps/pens via BLE. The CGM is manufactured using highly scalable semiconductor technology which provides high yield and low-cost for extremely small sensor. The thin polymer coated sensor has flexibility and mechanical integrity that improves integration with local tissue. The sensor is insertable at home, eliminating the need for doctor’s office procedure.
IMS has developed and tested the system with > 13 months of stable readings in lab, and > 1 month of in-vivo lifetime in a swine study. No adverse safety effects are observed in detailed animal (rats, swine) experiments. The system offers less blood-sensor lag time (< 3 minutes) and better accuracy in hypoglycemia (< 10% overall, < 6.5% in hypoglycemia).
Work is in progress to get regulatory approval for human feasibility testing.
IMS has developed world's smallest CGM sensor and has validated it in lab and an in animals.