Continuous glucose monitoring (CGM) systems are a key part of modern diabetes management. Although CGMs have advanced significantly, there are still areas of improvement in terms of accuracy, response speed, cost, and size. Such improvements are essential to have a wider adoption among patients. By integrating modern semiconductor and nano technologie, we have created extremely miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless, minimally invasive implant for electrochemical glucose sensing in the interstitial fluid. The implant is user-insertable under the skin using a custom injector and is also user-removable. The implant is powered via an external wearable transmitter using standard RFID technology. The transmitter uses a bluetooth low-energy (BLE) link to send the data to a wireless reader for data visualization and further analytics. The smartphone sends data securely to an online database where it is processed, stored, and is shared with caregivers.
We have verified system operation through extensive in-vitro and in-vivo testing (Figure). We have de-risked sensor fabrication and sterilization schemes. The wound healing response and histopathology studies indicate favorable safety and biocompatibility profile for the sensor as it uses standard materials being used in other implants. We are currently working to get FDA IDE for human feasibility testing
M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors Inc. Stock/Shareholder; Self; Integrated Medical Sensors Inc.
National Institutes of Health; National Science Foundation