Affiliation:
1. Department of Intensive Care Medicine, University Hospitals Leuven, Catholic University Leuven, Leuven, Belgium
2. Department of Electrical Engineering–ESAT (SCD-SISTA)/IBBT Future Health Department, Catholic University Leuven, Leuven, Belgium
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.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
79 articles.
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