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

Masahiko Ishikawa, David W. Schmidtke, Philip Raskin, Christopher A P Quinn

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25 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)295-301
Number of pages7
JournalJournal of Diabetes and its Complications
Volume12
Issue number6
DOIs
StatePublished - Nov 1998

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Glucose
Enzymes
Glucose Tolerance Test
Electric Wiring
Calibration
Glucose Oxidase
Horseradish Peroxidase
Type 1 Diabetes Mellitus
Gold
Hydrogen Peroxide
Needles
Meals
Blood Glucose
Volunteers
Electrodes
Regression Analysis
Confidence Intervals

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

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title = "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",
abstract = "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.",
author = "Masahiko Ishikawa and Schmidtke, {David W.} and Philip Raskin and Quinn, {Christopher A P}",
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AU - Raskin, Philip

AU - Quinn, Christopher A P

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