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

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

TRIAL REGISTRATION: https://www.clinicaltrials.gov, NCT 02491346; https://www.clinicaltrials.gov/ct2/show/NCT02491346?term=NCT02491346&cond=Hyperglycemia&cntry1=ES%3ACN&rank=1.