期刊
CRITICAL CARE MEDICINE
卷 45, 期 4, 页码 567-574出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/CCM.0000000000002252
关键词
blood glucose monitoring; critically ill; insulin dosing error; Monte Carlo simulation modeling; stratified glycemic accuracy analysis
资金
- National Center for Advancing Translational Sciences, National Institutes of Health [UL1TR000002]
- National Heart Lung and Blood Institute Emergency Medicine K12 Career Award [5K12HL108964]
- United States Army Medical Research and Material Command (USAMRMC) Combat Casualty Grant [81XWH-09-2-0194]
- Nova Biomedical
- Nova Biomedical (Boston, MA)
- National Institutes of Health
- Nova Biomedical's Medical and Scientific Affairs team
- Radiometer and Draeger Biomedical
Objectives: New data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S. Food and Drug Administration published new, more stringent guidelines for glucose meter manufacturers to evaluate the performance of blood glucose meters in critically ill patient settings. The primary objective of this international, multicenter, multidisciplinary clinical study was to develop and apply a rigorous clinical accuracy assessment algorithm, using four distinct statistical tools, to evaluate the clinical accuracy of a blood glucose monitoring system in critically ill patients. Design: Observational study. Setting: Five international medical and surgical ICUs. Patients: All patients admitted to critical care settings in the centers. Interventions: None. Measurements and Main Results: Glucose measurements were performed on 1,698 critically ill patients with 257 different clinical conditions and complex treatment regimens. The clinical accuracy assessment algorithm comprised four statistical tools to assess the performance of the study blood glucose monitoring system compared with laboratory reference methods traceable to a definitive standard. Based on POCT12-A3, the Clinical Laboratory Standards Institute standard for hospitals about hospital glucose meter procedures and performance, and Parkes error grid clinical accuracy performance criteria, no clinically significant differences were observed due to patient condition or therapy, with 96.10% and 99.3% glucose results meeting the respective criteria. Stratified sensitivity and specificity analysis (10 mg/dL glucose intervals, 50-150 mg/dL) demonstrated high sensitivity (mean = 95.2%, SD = +/- 0.02) and specificity (mean = 95. 8%, SD = +/- 0.03). Monte Carlo simulation modeling of the study blood glucose monitoring system showed low probability of category 2 and category 3 insulin dosing error, category 2 = 2.3% (41/1,815) and category 3 = 1.8% (32/1,815), respectively. Patient trend analysis demonstrated 99.1% (223/225) concordance in characterizing hypoglycemic patients. Conclusions: The multicomponent, clinical accuracy assessment algorithm demonstrated that the blood glucose monitoring system was acceptable for use in critically ill patient settings when compared to the central laboratory reference method. This clinical accuracy assessment algorithm is an effective tool for comprehensively assessing the validity of whole blood glucose measurement in critically ill patient care settings. (Crit Care Med 2017; 45:567-574)
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据