ABSTRACT
BACKGROUND: A feasibility version of the GlucoClear™ continuous glucose monitoring system (Edwards Lifesciences, Irvine, CA), the intravenous blood glucose (IVBG) system, developed to facilitate glycemic management, was evaluated. MATERIALS AND METHODS: Two pilot studies were conducted. Ten volunteers with diabetes (1,725 matched pairs) and 10 patients scheduled for intensive care unit (ICU) admission following surgery (1,393 matched pairs) were studied. The patients' blood glucose concentrations were monitored by the IVBG system every 5 min for up to 72 h. The accuracy of the IVBG system was calculated and compared with the Yellow Springs Instrument (YSI) (Yellows Springs, OH) and Radiometer (Copenhagen, Denmark) measurements to determine the percentage of matched pairs that met 15/20%, 10/15%, 12/12.5%, and 10/10% assessment criteria. Performance was calculated as the percentage of the total measurements that would have been displayed in an unblinded study. Adverse events were monitored. RESULTS: The accuracy of the IVBG system met the International Organization for Standardization ISO 15197 15/20% criterion (99.07% in volunteers, 99.43% in the ICU, and both vs. YSI) and the stricter 10/15% criterion (96.17% in volunteers, 96.77% in the ICU, and both vs. YSI) over the 72-h period and across a broad range of blood glucose concentrations. Performance was 89.97% in the ICU study. The adverse device effects included induration of the peripheral vein, mild bruising, and mild hematoma. In the volunteers, there were patency problems with six catheters. CONCLUSIONS: The IVBG system is safe, accurate, and reliable. This minimally invasive system was not affected by potentially interfering medications. Real-time measurements, alarms, and trends provided by the IVBG system might support glycemic control protocols and prevent glycemic events in critically ill patients.
