LONG-TERM CLINICAL APPLICATION OF WEARABLE ARTIFICIAL ENDOCRINE PANCREAS - THE DEVELOPMENT OF A NEEDLE - TYPE GLUCOSE SENSOR COVERED WITH PHOSPHOLIPID MEMBRANE -

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To prepare the long-life and stable glucose sensor, we developed the ferrocene-mediated needletype glucose sensor covered with newly designed biocompatible membrane, 2-methacryloyloxyethyl phosphorylcholine-co-n butyl methacrylate (MPC-co-BMA) membrane. In this membrane, the hydrophilic phosphorylcholine chains were grafted on the hydrophobic polymer surface. 1.The ferrocene-mediated needle-type glucose senso covered with poly (MPC-co-BMA) membrane achieved excellent results in vitro. Subcutaneous tissue blucose concentrations were measured in a wide range from 30 to more than 400 mg/dl. The correlation between subcutaneous tissue (Y) and blood (X) glucose concentrations was Y = 1.04X + 0.12 (r=0.98). The subcutaneous tissue glucose concentrations could be monitored precisely for 7 days without any in vivo calibrations, and for 14 days by introducting in vivo calibrations. 2.In ambulatory diabetic patients, physiological glycemic regulations could be acheived by application of wearable artificial endocrine pancreas with this ferrocene-mediated needle-type glucose sensor covered with poly (MPC-co BMA) membrane for 12 days by replacing the sensor every 5th day to avoid local infection at the site of sensor insertion. We therefore conclude that this sensor is stable and reliable, as compared to any other glucose sensors we developed.