Accuracy of a Continuous Glucose Monitor in the Intensive Care Unit: A Proposed Accuracy Standard and Calibration Protocol for Inpatient Use.

Abstract

Background and Aims: Guidelines now recommend inpatient continuous glucose monitor (CGM) use with confirmatory blood glucose measurements. However, the Food and Drug Administration has not yet officially approved CGM for inpatient use in large part because its accuracy has not been established in this setting. We tested the accuracy of the Dexcom G6 (G6) in 28 adults on an insulin infusion in a medical-surgical intensive care unit with 1064 matched CGM and arterial point-of-care pairs. Methods: The participants were on average 57.29 (SD 2.39) years, of whom 13 had a prior diagnosis of diabetes and 14 were admitted for a surgical diagnosis. The first 19 participants received the G6 without calibration and had a mean absolute relative difference (MARD) of 13.19% (IQR 5.11, 19.03) across 659 matched pairs, which just meets the critical care expert recommendation of MARD <14%. We then aimed to improve accuracy for the subsequent 9 participants using a calibration protocol. Results: The MARD for calibrated participants was 9.65% (3.03, 13.33), significantly lower than for uncalibrated participants (P < 0.001). Calibration also demonstrated excellent safety with 100% of values within the Clarke Error Grid zones A and B compared with 99.07% without calibration. Our protocol achieved the lowest MARD and safest CEG profile in the critical care setting and well exceeds the critical care expert recommendations. Our large sample of heterogenous critically ill patients also reached comparable accuracy to the MARD of 9% for G6 in outpatients. We believe our calibration protocol will allow G6 to be used with sufficient accuracy in inpatients.