Clinical Evaluation of a New, Miniaturized Biosensor for Self-monitoring of Blood Glucose

Abstract

The American Diabetes Association (ADA) has estimated that in 1993 7.8 million people in the United States had type 1 or type 2 diabetes (1) . About 70% of these individuals self-monitor blood glucose, and ∼2 million glucose meters were purchased in 1995–1996 (2) . The ADA’s recent reduction in the diagnostic threshold for diabetes is expected to increase the number of diagnosed patients (3) . Electrochemical meter systems offer some advantages for self-monitoring: compact size, rapid test time, and small sample volume. In this study, the analytical performance of a prototype of the FastTake™ system was evaluated for providing accurate and reproducible blood glucose results. The FastTake system is based on the enzymatic oxidation of glucose (glucose oxidase) using a mediator (ferricyanide) and electrochemical detection. The system produces rapid (15 s) plasma equivalent results from capillary whole blood samples over a wide range of glucose concentrations (200–6000 mg/L). The test strip contains a carbon-based working electrode, silver/silver chloride reference electrode, and dry reagents. This strip has been optimized to reduce temperature and hematocrit sensitivities, using nonconductive, partially silanized silica fillers, selected to balance the hydrophobicity/hydrophilicity of the reaction environment (4) . The silica filler forms a gelatinous layer, which restricts large sample components such as red blood cells from impairing the …