Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial)

Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.

Abstract

Background and 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.

Subjects and 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.

Trial registration: ClinicalTrials.gov NCT01799512.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • APACHE
  • Aged
  • Belgium / epidemiology
  • Cohort Studies
  • Female
  • Glucose / metabolism*
  • Glycated Hemoglobin / analysis
  • Humans
  • Hyperglycemia / blood
  • Hyperglycemia / diagnosis*
  • Hyperglycemia / epidemiology
  • Hyperglycemia / metabolism
  • Hypoglycemia / blood
  • Hypoglycemia / diagnosis*
  • Hypoglycemia / epidemiology
  • Hypoglycemia / metabolism
  • Hypoglycemic Agents / therapeutic use
  • Incidence
  • Insulin / therapeutic use
  • Insulin Infusion Systems*
  • Intensive Care Units*
  • Male
  • Microdialysis
  • Middle Aged
  • Monitoring, Physiologic / instrumentation*
  • Pilot Projects
  • Single-Blind Method
  • Subcutaneous Tissue / drug effects
  • Subcutaneous Tissue / metabolism*

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • hemoglobin A1c protein, human
  • Glucose

Associated data

  • ClinicalTrials.gov/NCT01799512