Safe and effective glycaemic control in premature infants: observational clinical results from the computerised STAR-GRYPHON protocol.

OBJECTIVE: Previous studies examine clinical outcomes of insulin therapy in neonatal intensive care units (NICUs), without first developing safe and effective control protocols. This research quantifies the safety and performance of a computerised model-based control algorithmSTAR-GRYPHON (Stochastic TARgeted Glucose Regulation sYstem to Prevent Hyper- and hypO-glycaemia in Neonates). DESIGN: Retrospective observational study of glycaemic control in very/extremely low birthweight infants treated with insulin from Christchurch Women's Hospital NICU between January 2013 and June 2017. Blood glucose (BG) outcomes and control performance is compared with retrospective data (n=22) and literature. INTERVENTIONS: Insulin infusion doses were calculated from 3 to 4 hourly BG measurements using a computerised model-based control algorithm, STAR-GRYPHON. MAIN OUTCOME MEASURES: Mean BG, time in targeted range and incidence of hypoglycaemia. RESULTS: STAR-GRYPHON (n=35) had lower mean BG concentration (7.0mmol/L vs 7.9 mmol/L), higher %BG within the 4.0-8.0 mmol/L target range (71.1% vs 50.9%) and lower %BG <4.0 mmol/L (0.6% vs 2.1%). There were only 2 BG <2.6 mmol/L (over n=2, 5.5% of patients, 0.03% of all BG outcomes), one of which may be attributed to clinical error. These results show better control to target and lower incidence of hypoglycaemia than most literature results from intensive insulin therapy protocols or study groups in children and infants. CONCLUSIONS: Model-based protocols can safely and effectively control BG in very premature infants and should be used in future studies to determine the effect of insulin therapy on clinical outcomes.