LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness: the LOGIC-1 single-center, randomized, controlled clinical trial

Tom Van Herpe, Dieter Mesotten, Pieter J Wouters, Jeroen Herbots, Evy Voets, Jo Buyens, Bart De Moor, Greet Van den Berghe, Tom Van Herpe, Dieter Mesotten, Pieter J Wouters, Jeroen Herbots, Evy Voets, Jo Buyens, Bart De Moor, Greet Van den Berghe

Abstract

Objective: Tight blood glucose control (TGC) in critically ill patients is difficult and labor intensive, resulting in poor efficacy of glycemic control and increased hypoglycemia rate. The LOGIC-Insulin computerized algorithm has been developed to assist nurses in titrating insulin to maintain blood glucose levels at 80-110 mg/dL (normoglycemia) and to avoid severe hypoglycemia (<40 mg/dL). The objective was to validate clinically LOGIC-Insulin relative to TGC by experienced nurses.

Research design and methods: The investigator-initiated LOGIC-1 study was a prospective, parallel-group, randomized, controlled clinical trial in a single tertiary referral center. A heterogeneous mix of 300 critically ill patients were randomized, by concealed computer allocation, to either nurse-directed glycemic control (Nurse-C) or algorithm-guided glycemic control (LOGIC-C). Glycemic penalty index (GPI), a measure that penalizes both hypoglycemic and hyperglycemic deviations from normoglycemia, was the efficacy outcome measure, and incidence of severe hypoglycemia (<40 mg/dL) was the safety outcome measure.

Results: Baseline characteristics of 151 Nurse-C patients and 149 LOGIC-C patients and study times did not differ. The GPI decreased from 12.4 (interquartile range 8.2-18.5) in Nurse-C to 9.8 (6.0-14.5) in LOGIC-C (P < 0.0001). The proportion of study time in target range was 68.6 ± 16.7% for LOGIC-C patients versus 60.1 ± 18.8% for Nurse-C patients (P = 0.00016). The proportion of severe hypoglycemic events was decreased in the LOGIC-C group (Nurse-C 0.13%, LOGIC-C 0%; P = 0.015) but not when considered as a proportion of patients (Nurse-C 3.3%, LOGIC-C 0%; P = 0.060). Sampling interval was 2.2 ± 0.4 h in the LOGIC-C group versus 2.5 ± 0.5 h in the Nurse-C group (P < 0.0001).

Conclusions: Compared with expert nurses, LOGIC-Insulin improved efficacy of TGC without increasing rate of hypoglycemia.

Trial registration: ClinicalTrials.gov NCT01420302.

Figures

Figure 1
Figure 1
Patients in the study. All patients admitted to the ICU from 22 August 2011 onward and in whom TGC was deemed necessary were screened for eligibility. Of those, 300 patients (150 patients after cardiac surgery and 150 patients with another reason for ICU admission) were effectively randomized and analyzed in the ITT analysis. Severe protocol violations occurred in 10 patients, who were excluded in the per protocol analysis.
Figure 2
Figure 2
Blood glucose (top), insulin infusion (second to top), and total carbohydrates (third to top) are all expressed as means (± SEM) and as a function of study time. Dashed lines indicate the Nurse-C group; solid lines indicate the LOGIC-C group. The shaded area in the top panel denotes the target blood glucose range (80–110 mg/dL). The bottom panel expresses the number of patients in the study, with black bars indicating the Nurse-C group, gray bars indicating the LOGIC-C, and the respective numbers of patients receiving steroids indicated by white lines in black bars for Nurse-C and black lines in gray bars for LOGIC-C.

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Source: PubMed

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