title: Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial).
abstract: OBJECTIVE
  Hyperglycemia 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.
  
  
  METHODS
  Thirty-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).
  
  
  RESULTS
  During 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%.
  
  
  CONCLUSIONS
  RT-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.
authors: 1 Department of Endocrinology, Diabetology & Metabolism, University of Antwerp , Edegem, Belgium .
authors: Christophe E M
authors: CE
authors: De Block
authors: 2 Department of Anesthesiology, Antwerp University Hospital , Edegem, Belgium .
authors: Jens
authors: J
authors: Gios
authors: 1 Department of Endocrinology, Diabetology & Metabolism, University of Antwerp , Edegem, Belgium .
authors: Nina
authors: N
authors: Verheyen
authors: 3 Laboratory of Endocrinology, University of Antwerp , Wilrijk, Belgium .
authors: Begoña
authors: B
authors: Manuel-y-Keenoy
authors: 4 Department of Critical Care Medicine, General Hospital Middelheim , Antwerp, Belgium .
authors: Peter
authors: P
authors: Rogiers
authors: 5 Department of Critical Care Medicine, Antwerp University Hospital, University of Antwerp , Edegem, Belgium .
authors: Philippe G
authors: PG
authors: Jorens
authors: 6 A. Menarini Diagnostics, Scientific and Technology Affairs , Florence, Italy .
authors: Cosimo
authors: C
authors: Scuffi
authors: 1 Department of Endocrinology, Diabetology & Metabolism, University of Antwerp , Edegem, Belgium .
authors: Luc F
authors: LF
authors: Van Gaal
mesh_terms: D018806:APACHE; D000368:Aged; D001530:Belgium / Q000453:epidemiology; D015331:Cohort Studies; D005260:Female; D005947:Glucose / Q000378:metabolism*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000378:metabolism; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000378:metabolism; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D015994:Incidence; D007328:Insulin / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D007362:Intensive Care Units; D008297:Male; D017551:Microdialysis; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D010865:Pilot Projects; D016037:Single-Blind Method; D040521:Subcutaneous Tissue / Q000187:drug effects / Q000378:metabolism*
chemical_list: D005947:Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human