Performance of the New CONTOUR® Blood Glucose Monitoring System with Capillary Blood
Year: 2007 Authors: Mary Kay Steele, Linda Schrock, John Baum Institutions: Minneapolis,MN, Elkhart,IN
The new CONTOUR® Blood Glucose Monitoring System (BGMS) provides results in five seconds, requires a sample volume of 0.6 µL, has a memory capacity for 480 results, and takes advantage of technology that compensates for the effect of hematocrit. The flavin adenine dinucleotide (FAD) - glucose dehydrogenase (GDH) - based test strip chemistry eliminates interference by maltose*, making the CONTOUR BGMS suitable for peritoneal dialysis patients using icodextrin or patients receiving immunoglobulin preparations containing maltose.
Evaluations of the user guide and system performance with capillary blood specimens were conducted in two clinical studies by 184 subjects with diabetes. Healthcare professionals (HCP) tested subjects’ blood in parallel. The studies assessed how well subjects, unfamiliar with the system and using only the product labeling materials for instruction, could perform a finger puncture and obtain an accurate blood glucose result with the CONTOUR BGMS. Meters referenced to plasma laboratory glucose methods and three test strip lots were used. Results obtained with the CONTOUR BGMS were compared to laboratory glucose values.
Ease of Use and Acceptability.
Over ninety-nine percent (99.4%) of the subjects correctly performed a blood glucose test using the instructions accompanying the product. Subject ratings of the CONTOUR BGMS ranged from an average of 3.1 to 3.9 on a scale of 0.0 to 4.0 (0 = unacceptable, 1= Poor, 2 = Good, 3 = Very Good, and 4= Excellent). Ninety-six percent (96.2%) of the subjects stated that the CONTOUR BGMS would meet their needs, and 95.1% indicated that the system was easy to use.
Blood Glucose Testing.
Analytical accuracy of combined lot data was statistically indistinguishable from data obtained with laboratory glucose analyzers. Agreement within ISO 15197:2003 accuracy limits of ±15 mg/dL or 20% of the laboratory glucose result was >96% for lay subject and HCP operators. Clinical accuracy was demonstrated by =97% of subject or HCP results falling within Zone A when the data were examined by error grid analysis. No results were inside Zones C, D, or E
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*The FAD-GDH-based chemistry also eliminates interference by galactose