title: The GlucoWatch biographer: a frequent automatic and noninvasive glucose monitor.
abstract: The GlucoWatch (Cygnus, Inc, Redwood City, CA, USA) biographer provides automatic, frequent and noninvasive blood glucose measurements for up to 12 h. The device extracts glucose through intact skin where it is measured by an amperometric biosensor. Clinical trials in a variety of environments have shown that the biographer provides accurate and precise glucose measurements when compared with serial fingerstick blood glucose measurements. Mean difference between these measurements was 0.26 mmol/L in the home environment (r = 0.80). Over 94% of biographer readings were in the clinically acceptable A+B region of the Clarke Error Grid. A slight positive bias is observed for the biographer readings at low glucose levels. Biographer precision, as measured by coefficient of variation (CV)%, is approximately 10%. The low glucose alert function of the biographer was able to detect up to 75% of hypoglycaemic episodes with a low false alert level. Skin irritation, characterized by erythema and oedema was either nonexistent or mild in over 87% of subjects and resolved in virtually all subjects without treatment in several days. The GlucoWatch biographer has been shown to be a safe and effective method to track glucose level trends and patterns, which should enable improved glycaemic control for many patients.
authors.affiliation: Cygnus, Inc, Redwood City, CA 94063, USA. Tierney@cygn.com
authors.forename: M J
authors.initials: MJ
authors.lastname: Tierney
authors.forename: J A
authors.initials: JA
authors.lastname: Tamada
authors.forename: R O
authors.initials: RO
authors.lastname: Potts
authors.forename: R C
authors.initials: RC
authors.lastname: Eastman
authors.forename: K
authors.initials: K
authors.lastname: Pitzer
authors.forename: N R
authors.initials: NR
authors.lastname: Ackerman
authors.forename: S J
authors.initials: SJ
authors.lastname: Fermi
mesh_terms: D000704:Analysis of Variance; D015374:Biosensing Techniques; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation; D002986:Clinical Trials as Topic; D003920:Diabetes Mellitus / Q000097:blood*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000175:diagnosis; D008297:Male; D008875:Middle Aged