The accuracy, response speed, cost, and size are important determinants of the performance of a Continuous Glucose Monitoring (CGM) system. Current CGM systems either require (i) percutaneous wires with bulky skin-worn transmitters, frequent removal/insertion, and thousands of dollars, or (ii) bulky implants, special semi-surgical procedures, and frequent recalibrations. By integrating modern semiconductor and nano technologies, IMS invented miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless, minimally invasive subdermal CGM platform. The sensor is user-insertable under the skin using an injector and is also user-removable. It is powered via an external smartwatch transmitter using standard RFID technology. This enables low power RF communication with the transmitter. The transmitter uses a bluetooth low-energy link to send the data to a smartphone reader enabling machine-learning based decision support.
IMS has verified the system through extensive in-vitro and in-vivo testing; the latest test for more than 1 month in a porcine model (Figure 1). The sensor shows fast response speed, best-in-class accuracy, and highly biocompatible operation due to use of standard materials and small size. We are currently working to get FDA IDE for first-in-human study.
Figure 1. Sensor Performance Results (a) using FDA iCGM (b) Clarke Error Grid.
M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors.
National Institutes of Health (DK109811, DK111001)