Performance of the DIDGET Blood Glucose Monitoring System in Children, Teens, and Young Adults

Background: This study evaluated the performance of the DIDGET ® blood glucose monitoring system (BGMS) in the hands of its intended users: children, teens, and young adults with diabetes. Methods: Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values). Results: