Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial
Creators
- 1. Clinical Division and Laboratory of Intensive Care Medicine, Academic Department of Cellular and Molecular Medicine, KU Leuven, University Hospitals Leuven, Herestraat 49, B-3000, Leuven, Belgium
- 2. Department of Anesthesia & Intensive Care, Jessa Hospital, Salvatorstraat 20, B-3500, Hasselt, Belgium
- 3. Department of Electrical Engineering (ESAT), Research Division SCD, iMINDS Future Health Dept, KU Leuven, Kasteelpark Arenberg 10, B-3001, Leuven (Heverlee), Belgium
- 4. Department of Intensive Care Medicine, Academic Medical Center, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands
- 5. Clinical Department of General Internal Medicine, Medical Intensive Care Unit, University Hospitals Leuven, Herestraat 49, B-3000, Leuven, Belgium
Description
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.