Miniaturization is a key performance driver for CGM sensors for diabetes management. We have combined semiconductor and nanotechnology to realize an extremely miniaturized (0.1mmx0.6mmx3mm i.e., smaller than a sesame seed) fully wireless implant for electrochemical glucose sensing in interstitial fluid. This small size minimizes foreign body response, thus increasing longevity and decreasing calibration frequency. The implant is inserted under the skin using a custom injector and is removed via a simple procedure under local anesthesia. The implant is powered via an external wearable transmitter using standard RFID technology, also enabling low power communication between the two. The transmitter uses a bluetooth link to communicate with a smartphone reader for data visualization and further analytics. The smartphone sends data securely to an online database where it is shared with caregivers.

We have verified our digital health system's 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 optimizing glucose oxidase system’s chemistry to achieve optimal in-vivo performance leading to human feasibility testing.

M. Mujeeb-U-Rahman: None. M. Honarvar Nazari: None. M. Sencan: Employee; Self; Integrated Medical Sensors, INC.

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