Implantation of a refillable glucose monitoring-telemetry device.

This study describes the components and short-term in vivo evaluation of an integrated implantable system consisting of an amperometric glucose biosensor, a miniature potentiostat, a FM signal transmitter, and a power supply. The device (dimensions: 5.0 x 7.0 x 1.5 cm) was implanted subcutaneously in healthy mongrel dogs. The biosensor performance was evaluated in vitro prior to implantation using standard solutions simulating the physiological environment. A linear response to glucose concentration was observed throughout the physiological and pathophysiological range (with an upper limit of 25 mM glucose, and a sensitivity of 0.5 microA/mM). The results of short-term subcutaneous implantation of the integrated system demonstrated good agreement between the glucose concentration measured by the biosensor and that obtained using standard glucose determination methods. The delay-time between the tissue glucose level (measured by the biosensor) and the blood glucose level (obtained by standard methodology) was 3-7 min. These results demonstrated the feasibility of data transmission by a telemetry system through the skin of a dog and allowed the commencement of chronic in vivo testing. During the chronic implantation the biosensor was refilled in vivo. A rejuvenation of the sensor's response after refilling was observed suggesting the potential of such sensors for long-term implantation.