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Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study.

ABSTRACT: The Space Glucose Control (SGC) system is a computer-assisted device combining infusion pumps with the enhanced Model Predictive Control algorithm to achieve the target blood glucose (BG) level safely. The objective of this study was to evaluate the efficacy and safety of glycemic control by SGC with customized BG target range of 5.8-8.9 mmol/L in the critically ill patients.It is a randomized controlled trial of seventy critically ill patients with mechanical ventilation and hyperglycemia (BG ? 9.0 mmol/L). Thirty-six patients in the SGC group and 34 in the routine glucose management group were observed for three consecutive days. Target BG for both groups was 5.8-8.9 mmol/L. The primary outcome was the percentage time in the target range.The percentage time within BG target range in the SGC group (69 ± 15%) was significantly higher than in the routine management group (52 ± 24%; P< 0.01). No measurement was ?2.2 mmol/L, and there was only one episode of hypoglycemia (2.3-3.3 mmol/L) in each group. The average BG was significantly lower in the SGC group (7.8 ± 0.7 mmol/L) than in the routine management group (9.1 ± 1.6 mmol/L, P< 0.001). Target BG level was reached earlier in the SGC group than routine management group (2.5 ± 2.9 vs. 12.1 ± 15.3 h, P= 0.001). However, the SGC group performed worse for daily insulin requirement (59.8 ± 39.3 vs. 28.4 ± 36.7 U, P= 0.001) and sampling interval (2.0 ± 0.5 vs. 3.7 ± 0.5 h, P< 0.001) than the routine management group did. Multiple linear regression showed that the intervention group remained a significant individual predictor (P < 0.001) of the percentage time in target range.The SGC system, with a BG target of 5.8-8.9 mmol/L, resulted in effective and reliable glycemic control with few hypoglycemic episodes in critically ill patients with mechanical ventilation and hyperglycemia. However, the workload was increased.http://www.clinicaltrials.gov, NCT 02491346; https://www.clinicaltrials.gov/ct2/show/NCT02491346?term=NCT02491346&cond=Hyperglycemia&cntry1=ES%3ACN&rank=1.

SUBMITTER: Xu B

PROVIDER: S-EPMC5586171 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study.

Xu Biao B Jiang Wei W Wang Chun-Yao CY Weng Li L Hu Xiao-Yun XY Peng Jin-Min JM Du Bin B

Chinese medical journal 20170901 17

<h4>Background</h4>The Space Glucose Control (SGC) system is a computer-assisted device combining infusion pumps with the enhanced Model Predictive Control algorithm to achieve the target blood glucose (BG) level safely. The objective of this study was to evaluate the efficacy and safety of glycemic control by SGC with customized BG target range of 5.8-8.9 mmol/L in the critically ill patients.<h4>Methods</h4>It is a randomized controlled trial of seventy critically ill patients with mechanical ...[more]

PMID: 28836546

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Project description:BACKGROUND:In multicenter studies, tight glycemic control targeting a normal blood glucose level has not been shown to improve outcomes in critically ill adults or children after cardiac surgery. Studies involving critically ill children who have not undergone cardiac surgery are lacking. METHODS:In a 35-center trial, we randomly assigned critically ill children with confirmed hyperglycemia (excluding patients who had undergone cardiac surgery) to one of two ranges of glycemic control: 80 to 110 mg per deciliter (4.4 to 6.1 mmol per liter; lower-target group) or 150 to 180 mg per deciliter (8.3 to 10.0 mmol per liter; higher-target group). Clinicians were guided by continuous glucose monitoring and explicit methods for insulin adjustment. The primary outcome was the number of intensive care unit (ICU)-free days to day 28. RESULTS:The trial was stopped early, on the recommendation of the data and safety monitoring board, owing to a low likelihood of benefit and evidence of the possibility of harm. Of 713 patients, 360 were randomly assigned to the lower-target group and 353 to the higher-target group. In the intention-to-treat analysis, the median number of ICU-free days did not differ significantly between the lower-target group and the higher-target group (19.4 days [interquartile range {IQR}, 0 to 24.2] and 19.4 days [IQR, 6.7 to 23.9], respectively; P=0.58). In per-protocol analyses, the median time-weighted average glucose level was significantly lower in the lower-target group (109 mg per deciliter [IQR, 102 to 118]; 6.1 mmol per liter [IQR, 5.7 to 6.6]) than in the higher-target group (123 mg per deciliter [IQR, 108 to 142]; 6.8 mmol per liter [IQR, 6.0 to 7.9]; P<0.001). Patients in the lower-target group also had higher rates of health care-associated infections than those in the higher-target group (12 of 349 patients [3.4%] vs. 4 of 349 [1.1%], P=0.04), as well as higher rates of severe hypoglycemia, defined as a blood glucose level below 40 mg per deciliter (2.2 mmol per liter) (18 patients [5.2%] vs. 7 [2.0%], P=0.03). No significant differences were observed in mortality, severity of organ dysfunction, or the number of ventilator-free days. CONCLUSIONS:Critically ill children with hyperglycemia did not benefit from tight glycemic control targeted to a blood glucose level of 80 to 110 mg per deciliter, as compared with a level of 150 to 180 mg per deciliter. (Funded by the National Heart, Lung, and Blood Institute and others; HALF-PINT ClinicalTrials.gov number, NCT01565941 .).

Dataset Information

Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study.

Publications

Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study.

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