title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: BD Technologies , Research Triangle Park, North Carolina, USA. kevin_judge@bd.com
authors.forename: Kevin
authors.initials: K
authors.lastname: Judge
authors.forename: Linda
authors.initials: L
authors.lastname: Morrow
authors.forename: Alexander G
authors.initials: AG
authors.lastname: Lastovich
authors.forename: David
authors.initials: D
authors.lastname: Kurisko
authors.forename: Steven C
authors.initials: SC
authors.lastname: Keith
authors.forename: Jacob
authors.initials: J
authors.lastname: Hartsell
authors.forename: Bruce
authors.initials: B
authors.lastname: Roberts
authors.forename: Elaine
authors.initials: E
authors.lastname: McVey
authors.forename: Kristin
authors.initials: K
authors.lastname: Weidemaier
authors.forename: Khin
authors.initials: K
authors.lastname: Win
authors.forename: Marcus
authors.initials: M
authors.lastname: Hompesch
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015374:Biosensing Techniques / Q000379:methods*; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods*; D002135:Calcium-Binding Proteins / Q000378:metabolism*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D005690:Galactose / Q000097:blood; D015309:Glucose Clamp Technique; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009004:Monosaccharide Transport Proteins / Q000378:metabolism*; D033902:Periplasmic Binding Proteins / Q000378:metabolism*; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D002135:Calcium-Binding Proteins; D009004:Monosaccharide Transport Proteins; D033902:Periplasmic Binding Proteins; C023550:galactose-binding protein; D005690:Galactose