Department of Intensive Care Medicine, University Hospitals Leuven, Catholic University Leuven, Leuven, Belgium.
Diabetes Care. 2013 Feb;36(2):188-94. doi: 10.2337/dc12-0584. Epub 2012 Sep 6.
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.
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.
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).
Compared with expert nurses, LOGIC-Insulin improved efficacy of TGC without increasing rate of hypoglycemia.
危重症患者的血糖严格控制（TGC）既困难又耗费精力，导致血糖控制效果不佳且低血糖发生率增加。LOGIC-Insulin 计算机算法旨在帮助护士调整胰岛素剂量，将血糖水平维持在 80-110mg/dL（正常血糖），并避免严重低血糖（<40mg/dL）。本研究旨在通过经验丰富的护士验证 LOGIC-Insulin 相对于 TGC 的临床效果。
本研究是由研究者发起的 LOGIC-1 前瞻性、平行组、随机、对照临床试验，在一家三级转诊中心进行。300 名危重症患者被随机分为两组，通过隐藏式计算机分配，一组接受护士指导的血糖控制（Nurse-C），另一组接受算法指导的血糖控制（LOGIC-C）。血糖惩罚指数（GPI）是评估血糖控制效果的指标，它惩罚血糖过高和过低的情况，衡量血糖控制效果，严重低血糖（<40mg/dL）的发生率是安全性指标。
151 名 Nurse-C 患者和 149 名 LOGIC-C 患者的基线特征和研究时间无差异。Nurse-C 组的 GPI 从 12.4（四分位距 8.2-18.5）降至 LOGIC-C 组的 9.8（6.0-14.5）（P<0.0001）。LOGIC-C 组的目标范围内时间比例为 68.6±16.7%，Nurse-C 组为 60.1±18.8%（P=0.00016）。LOGIC-C 组严重低血糖事件的比例降低（Nurse-C 组 0.13%，LOGIC-C 组 0%；P=0.015），但考虑到患者比例，差异无统计学意义（Nurse-C 组 3.3%，LOGIC-C 组 0%；P=0.060）。LOGIC-C 组的采样间隔为 2.2±0.4h，Nurse-C 组为 2.5±0.5h（P<0.0001）。
与经验丰富的护士相比，LOGIC-Insulin 可提高 TGC 的效果，且不增加低血糖的发生率。
