1. Continuous glucose monitoring using a novel glucose/galactose binding protein: results of a 12-hour feasibility study with the becton dickinson glucose/galactose binding protein sensor.
- Author
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Judge K, Morrow L, Lastovich AG, Kurisko D, Keith SC, Hartsell J, Roberts B, McVey E, Weidemaier K, Win K, and Hompesch M
- Subjects
- Adolescent, Adult, Aged, Blood Glucose analysis, Blood Glucose metabolism, Blood Glucose Self-Monitoring instrumentation, Female, Galactose blood, Glucose Clamp Technique, Humans, Linear Models, Male, Middle Aged, Reproducibility of Results, Young Adult, Biosensing Techniques methods, Blood Glucose Self-Monitoring methods, Calcium-Binding Proteins metabolism, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 2 blood, Monosaccharide Transport Proteins metabolism, Periplasmic Binding Proteins metabolism
- Abstract
Aim: This study evaluated the performance characteristics of a prototype Becton Dickinson (BD) (Franklin Lakes, NJ) glucose/galactose binding protein (GGBP) sensor placed intradermally (BD-ID) or subcutaneously (BD-SC) for continuous glucose monitoring., Materials and Methods: The performance characteristics of the prototype BD GGBP sensor after intradermal or subcutaneous placement were assessed, and its accuracy was compared with that of a glucose oxidase (GOx)-based sensor and a standard laboratory method (YSI STAT2300 analyzer, Yellow Springs Instrument, Yellow Springs, OH) under glucose clamp conditions and during an off-clamp meal challenge in 40 patients with type 1 or 2 diabetes in a 12-h feasibility study., Results: BD-ID and BD-SC sensors performed as well as or better than the GOx-based sensor (differences in median absolute percentage error 2-4 points in hyperglycemic and euglycemic regions, ≥ 10 points in the hypoglycemic region). For glucose values ≤ 100 mg/dL, the percentage of measurement values in consensus error plot Zone A was substantially higher with the GGBP sensors than the GOx-based sensor., Conclusions: The BD prototype sensor demonstrated competitive accuracy relative to a GOx-based sensor and a YSI blood standard with a single calibration and minimal warm-up. Current development work is focused on the design and manufacture of a commercially feasible device that will include marked enhancements to device robustness and longevity.
- Published
- 2011
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