LAUSR

Introduction/Hypothesis: The Center for Medicare and Medicaid Services (CMS) labeled bedside glucose meters (BGM) as “off-label use” for critically ill patients due to accuracy concerns raised by the Food and Drug Administration. We examine BGM use and accuracy in patients with the 13 clinical factors (table 1) determined by CMS to be off label use. Methods: BGM analyzed capillary samples were simultaneously compared to venous draw lab analyzed (lab) samples throughout the Advocate Health System, Adult Intensive Care Units. This analysis was performed if they had one or more of the clinical factors at the morning lab draw or if the patient developed a factor throughout the day. Samples were considered to be clinically equivalent if they were within 20%. To evaluate the association between clinical characteristics and the glucose equivalence, multivariate linear and logistic regression were performed. This is an IRB approved study AHC-6910. Results: A total of 2626 samples were included in the analysis and 96 (3.7%) exceeded 20%. Vasopressor use and glucose > 400 were predictive of non-equivalence (OR = 2.245, 95% CI = 1.481–3.405, p<0.001; OR=3.298, CI= 1.732 6.279, p <0.001, respectively). MAP < 65 was associated with an increased difference (β = 0.063, 95% CI = 0.162 0.664, p=0.001) and HHNS was associated with a decreased difference (β = 0.063, 95% CI = 0.162 0.664, p=0.001). Conclusions: Of the 13 factors examined glucose >400 and use of vasopressors were significant for non-equivalence between BGM and lab values indicating lab draw glucose samples should be used on these patients for safety concerns. The glucose >400 result is expected as it is out of the range of the meter capabilities per the manufacturer. Clinically, confirmation of a seemingly inappropriate bedside sample is indicated for MAP <65. Continued studies of subgroups are warranted evaluating for additional mitigating factors.