QC Test for Noninvasive Glucose Monitoring System

Abstract

A test kit for testing the efficacy of an iontophoretic sampling system of an automatic, noninvasive and frequent glucose monitoring system, GlucoWatch (Cygnus, Inc., Redwood City, CA) biographer, is described in this article. In this novel test kit, the iontophoretic sampling system has first and second surfaces. The first surface has a reservoir containing an ionic conductive medium, as well as enzyme capable of reacting with glucose to produce hydrogen peroxide. This enzymatically produced hydrogen peroxide is consequently electrochemically determined by a Pt-graphite electrode. Platinum in the platinum-graphite catalyzes the oxidation of hydrogen peroxide. Therefore, the amperometric signal is proportional to the concentration of glucose. The electrochemical response has been shown to correlate with the performance of the noninvasive iontophoresis glucose monitoring system as determined in clinical studies using thermally degraded AutoSensors. The test kit has been validated and proven to be specific, linear, precise, and stability indicating. This quality control (QC) test kit is a reliable testing tool for evaluating the performance of the GlucoWatch biographer and AutoSensor.