TY - JOUR
T1 - Initial evaluation of a 290-μm diameter subcutaneous glucose sensor
T2 - Glucose monitoring with a biocompatible, flexible-wire, enzyme-based amperometric microsensor in diabetic and nondiabetic humans
AU - Ishikawa, Masahiko
AU - Schmidtke, David W.
AU - Raskin, Philip
AU - Quinn, Christopher A P
N1 - Funding Information:
This study was supported in part by grants from the National Institutes of Health (M01 RR00633 and DK42015). The authors thank the study volunteers for their participation, Mr. Andrew Young for help in the design and construction of the bipotentiostat, and the staff members of the General Clinical Research Center for their continuous support.
PY - 1998/11
Y1 - 1998/11
N2 - Results of the initial clinical evaluation in 20 human subjects of a subcutaneously implanted microsensor-based amperometrically glycemia- monitoring system, carried out between April 1994 and June 1995, are reported. The system was based on the electrical connection ('wiring') of the reaction centers of glucose oxidase to a gold electrode and on elimination of the chemicals that interfere with glucose monitoring through their horseradish peroxidase-catalyzed oxidation by internally generated hydrogen peroxide. The sensor was finer than a 29-gauge needle and had no leachable components. Because of its high selectivity for glucose, the sensor output was virtually nil at zero glucose level. This enables prompt 'one-point' in vivo calibration of the sensor with a single blood glucose sample. Microsensors were subcutaneously implanted in ten nondiabetic and ten insulin-dependent diabetes mellitus (IDDM) volunteers. All subjects underwent standard meal tests and intravenous glucose-tolerance tests (IVGTT) in addition to hourly plasma glucose measurements. The sensor signals were continuously recorded, and the glucose concentration estimates were derived by calibrating the sensor using a single blood sample (one-point calibration). Regression analysis revealed that the sensor-estimated glucose concentrations were linearly related to the plasma glucose concentrations (r2 = 0.75) over a wide glucose concentration range (2-28 mmol/L) (sensor estimate = plasma * 0.96 + 0.26 mmol/L). The difference between the estimated and actual glucose concentration was -0.13 ± 0.23 mmol/L [mean ± 95% confidence interval (CI), n = 546], and 95% of the estimates fell in clinically acceptable zones of the Clarke error grid. The sensing delay time was 10,4 ± 2.3 min as measured by the IVGTT. The subjects reported no discomfort associated with wearing the sensors.
AB - Results of the initial clinical evaluation in 20 human subjects of a subcutaneously implanted microsensor-based amperometrically glycemia- monitoring system, carried out between April 1994 and June 1995, are reported. The system was based on the electrical connection ('wiring') of the reaction centers of glucose oxidase to a gold electrode and on elimination of the chemicals that interfere with glucose monitoring through their horseradish peroxidase-catalyzed oxidation by internally generated hydrogen peroxide. The sensor was finer than a 29-gauge needle and had no leachable components. Because of its high selectivity for glucose, the sensor output was virtually nil at zero glucose level. This enables prompt 'one-point' in vivo calibration of the sensor with a single blood glucose sample. Microsensors were subcutaneously implanted in ten nondiabetic and ten insulin-dependent diabetes mellitus (IDDM) volunteers. All subjects underwent standard meal tests and intravenous glucose-tolerance tests (IVGTT) in addition to hourly plasma glucose measurements. The sensor signals were continuously recorded, and the glucose concentration estimates were derived by calibrating the sensor using a single blood sample (one-point calibration). Regression analysis revealed that the sensor-estimated glucose concentrations were linearly related to the plasma glucose concentrations (r2 = 0.75) over a wide glucose concentration range (2-28 mmol/L) (sensor estimate = plasma * 0.96 + 0.26 mmol/L). The difference between the estimated and actual glucose concentration was -0.13 ± 0.23 mmol/L [mean ± 95% confidence interval (CI), n = 546], and 95% of the estimates fell in clinically acceptable zones of the Clarke error grid. The sensing delay time was 10,4 ± 2.3 min as measured by the IVGTT. The subjects reported no discomfort associated with wearing the sensors.
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U2 - 10.1016/S1056-8727(98)00011-7
DO - 10.1016/S1056-8727(98)00011-7
M3 - Article
C2 - 9877461
AN - SCOPUS:0032214537
SN - 1056-8727
VL - 12
SP - 295
EP - 301
JO - Journal of Diabetes and Its Complications
JF - Journal of Diabetes and Its Complications
IS - 6
ER -