Initial evaluation of a 290-μm diameter subcutaneous glucose sensor: Glucose monitoring with a biocompatible, flexible-wire, enzyme-based amperometric microsensor in diabetic and nondiabetic humans

摘要: Abstract Results of the initial clinical evaluation in 20 human subjects a subcutaneously implanted microsensor-based amperometrically glycemia-monitoring system, carried out between April 1994 and June 1995, are reported. The system was based on electrical connection ("wiring") reaction centers glucose oxidase to gold electrode elimination chemicals that interfere with monitoring through their horseradish peroxidase-catalyzed oxidation by internally generated hydrogen peroxide. sensor finer than 29-gauge needle had no leachable components. Because its high selectivity for glucose, output virtually nil at zero level. This enables prompt "one-point" vivo calibration single blood sample. Microsensors were ten nondiabetic insulin-dependent diabetes mellitus (IDDM) volunteers. All underwent standard meal tests intravenous glucose-tolerance (IVGTT) addition hourly plasma measurements. signals continuously recorded, concentration estimates derived calibrating using sample (one-point calibration). Regression analysis revealed sensor-estimated concentrations linearly related ( r 2 = 0.75) over wide range (2–28 mmol/L) (sensor estimate=plasma * 0.96 + 0.26 mmol/L). difference estimated actual −0.13 ± 0.23 mmol/L [mean 95% confidence interval (CI), n 546], fell clinically acceptable zones Clarke error grid. sensing delay time 10.4 2.3 min as measured IVGTT. reported discomfort associated wearing sensors.