Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management

• Published in: Journal of diabetes science and technology 2011-09, Vol.5 (5), p.1144-1153
• Main Authors: List, Susan M, Starks, Nykole, Baum, John, Greene, Carmine, Pardo, Scott, Parkes, Joan L, Schachner, Holly C, Cuddihy, Robert
• Format: Article
• Language: English
• Subjects: Adult; Aged; Blood Glucose - analysis; Blood Glucose Self-Monitoring - instrumentation; Blood Glucose Self-Monitoring - standards; Blood Specimen Collection - instrumentation; Blood Specimen Collection - standards; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 2 - blood; Female; Humans; Male; Middle Aged; Original; Reproducibility of Results
• ISSN: 1932-2968; 1932-3107
• DOI: 10.1177/193229681100500516

This study evaluated performance and product labeling of CONTOUR® USB, a new blood glucose monitoring system (BGMS) with integrated diabetes management software and a universal serial bus (USB) port, in the hands of untrained lay users and health care professionals (HCPs). Subjects and HCPs tested subject's finger stick capillary blood in parallel using CONTOUR USB meters; deep finger stick blood was tested on a Yellow Springs Instruments (YSI) glucose analyzer for reference. Duplicate results by both subjects and HCPs were obtained to assess system precision. System accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines [within ±15 mg/dl of mean YSI results (samples