Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.

BACKGROUND: Blood glucose control in the intensive care unit (ICU) has the potential to save lives. However, maintaining blood glucose concentrations within a chosen target range is difficult in clinical practice and holds risk of potentially harmful hypoglycemia. Clinically validated computer algorithms to guide insulin dosing by nurses have been advocated for better and safer blood glucose control. METHODS: We conducted an international, multicenter, randomized controlled trial involving 1550 adult, medical and surgical critically ill patients, requiring blood glucose control. Patients were randomly assigned to algorithm-guided blood glucose control (LOGIC-C, n = 777) or blood glucose control by trained nurses (Nurse-C, n = 773) during ICU stay, according to the local target range (80-110 mg/dL or 90-145 mg/dL). The primary outcome measure was the quality of blood glucose control, assessed by the glycemic penalty index (GPI), a measure that penalizes hypoglycemic and hyperglycemic deviations from the chosen target range. Incidence of severe hypoglycemia (<40 mg/dL) was the main safety outcome measure. New infections in ICU, duration of hospital stay, landmark 90-day mortality and quality of life were clinical safety outcome measures. RESULTS: The median GPI was lower in the LOGIC-C (10.8 IQR 6.2-16.1) than in the Nurse-C group (17.1 IQR 10.6-26.2) (P < 0.001). Mean blood glucose was 111 mg/dL (SD 15) in LOCIC-C versus 119 mg/dL (SD 21) in Nurse-C, whereas the median time-in-target range was 67.0% (IQR 52.1-80.1) in LOGIC-C versus 47.1% (IQR 28.1-65.0) in the Nurse-C group (both P < 0.001). The fraction of patients with severe hypoglycemia did not differ between LOGIC-C (0.9%) and Nurse-C (1.2%) (P = 0.6). The clinical safety outcomes did not differ between groups. The sampling interval was 2.3 h (SD 0.5) in the LOGIC-C group versus 3.0 h (SD 0.8) in the Nurse-C group (P < 0.001). CONCLUSIONS: In a randomized controlled trial of a mixed critically ill patient population, the use of the LOGIC-Insulin blood glucose control algorithm, compared with blood glucose control by expert nurses, improved the quality of blood glucose control without increasing hypoglycemia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02056353 . Registered on 4 February 2014.

Software-guided insulin dosing: tight glycemic control and decreased glycemic derangements in critically ill patients.

OBJECTIVE: To determine whether glycemic derangements are more effectively controlled using software-guided insulin dosing compared with paper-based protocols. PATIENTS AND METHODS: We prospectively evaluated consecutive critically ill patients treated in a tertiary hospital surgical intensive care unit (ICU) between January 1 and June 30, 2008, and between January 1 and September 30, 2009. Paper-based protocol insulin dosing was evaluated as a baseline during the first period, followed by software-guided insulin dosing in the second period. We compared glycemic metrics related to hyperglycemia, hypoglycemia, and glycemic variability during the 2 periods. RESULTS: We treated 110 patients by the paper-based protocol and 87 by the software-guided protocol during the before and after periods, respectively. The mean ICU admission blood glucose (BG) level was higher in patients receiving software-guided intensive insulin than for those receiving paper-based intensive insulin (181 vs 156 mg/dL; P=.003, mean of the per-patient mean). Patients treated with software-guided intensive insulin had lower mean BG levels (117 vs 135 mg/dL; P=.0008), sustained greater time in the desired BG target range (95-135 mg/dL; 68% vs 52%; P=.0001), had less frequent hypoglycemia (percentage of time BG level was <70 mg/dL: 0.51% vs 1.44%; P=.04), and showed decreased glycemic variability (BG level per-patient standard deviation from the mean: ±29 vs ±42 mg/dL; P=.01). CONCLUSION: Surgical ICU patients whose intensive insulin infusions were managed using the software-guided program achieved tighter glycemic control and fewer glycemic derangements than those managed with the paper-based insulin dosing regimen.