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Diabetes Technol. Ther. · Dec 2015
Randomized Controlled Trial Multicenter StudyRandomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial).
- Christophe E M De Block, Jens Gios, Nina Verheyen, Begoña Manuel-y-Keenoy, Peter Rogiers, Philippe G Jorens, Cosimo Scuffi, and Luc F Van Gaal.
- 1 Department of Endocrinology, Diabetology & Metabolism, University of Antwerp , Edegem, Belgium .
- Diabetes Technol. Ther. 2015 Dec 1; 17 (12): 889-98.
Background And ObjectiveHyperglycemia occurs commonly in patients admitted to medical intensive care units (MICUs). Whether real-time (RT) continuous glucose monitoring (CGM) improves glycemic control and variability and reduces hypoglycemia in severely ill MICU patients with an Acute Physiology and Chronic Health Evaluation II (APACHE-II) score of ≥20 has not been studied.Subjects And MethodsThirty-five patients (66 ± 10 years of age; APACHE-II score, 28 ± 6) were randomly assigned to RT-CGM (n = 16) using the GlucoDay(®)S (A. Menarini Diagnostics, Florence, Italy) device or to blinded CGM. Insulin was infused using a modified Yale protocol targeting a blood glucose level between 80 and 120 mg/dL. Outcome measures were percentage of time in normoglycemia (80-110 mg/dL) and in hypoglycemia (<60 mg/dL), glycemic variability (SD, coefficient of variation, mean amplitude of glucose excursions, and mean of daily differences), and CGM accuracy (error grid analyses, Bland-Altman bias plot, and mean absolute relative deviation).ResultsDuring 96 h of monitoring, glycemia reached target (80-110 mg/dL) in 37 ± 15%, was between 70 and 180 mg/dL in 91 ± 10%, and <60 mg/dL in 2 ± 2% of the time. In the RT-CGM group glycemia averaged 119 ± 17 mg/dL versus 122 ± 11 mg/dL in the control group. Parameters of glucose variability and percentages of time at target glycemia and in hypoglycemia were similar between groups. GlucoDayS values and arterial glycemia correlated well, with 98.6% of data falling in Zones A and B of the error grid analysis. Mean absolute relative devation was 11.2%.ConclusionsRT-CGM did not ameliorate glucose control or variability; neither did it reduce the number of hypoglycemic events, but our insulin infusion protocol led to overall good glucose control without a significant hypoglycemia risk, making further improvement difficult.
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