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Safe and effective glycaemic control in premature infants: observational clinical results from the computerised
Jennifer L Knopp Nee Dickson1, Adrienne M Lynn2, Geoffrey M Shaw3
1Department of Mechanical Engineering, University of Canterbury, Christchurch, New Zealand.
Insights
The STAR-GRYPHON computerised algorithm safely and effectively controlled blood glucose in premature infants. This model-based approach demonstrated better glycemic control and lower hypoglycemia incidence compared to existing methods.
Area of Science:
- Neonatal intensive care
- Endocrinology
- Medical device technology
Background:
- Clinical outcomes of insulin therapy in neonatal intensive care units (NICUs) are studied, but safe control protocols are lacking.
- This research addresses the need for effective glycaemic control strategies in neonates.
Purpose of the Study:
- To quantify the safety and performance of the STAR-GRYPHON (Stochastic TARgeted Glucose Regulation sYstem to Prevent Hyper- and hypO-glycaemia in Neonates) computerised model-based control algorithm.
- To compare glycaemic control outcomes with retrospective data and literature.
Main Methods:
- A retrospective observational study was conducted on very/extremely low birthweight infants treated with insulin.
- Insulin infusion doses were calculated using the STAR-GRYPHON algorithm based on 3-4 hourly blood glucose measurements.
- Key outcomes included mean blood glucose, time within the target range, and incidence of hypoglycaemia.
Main Results:
- The STAR-GRYPHON system achieved a lower mean blood glucose (7.0 mmol/L vs 7.9 mmol/L) and a higher percentage of blood glucose readings within the 4.0-8.0 mmol/L target range (71.1% vs 50.9%).
- Incidence of hypoglycaemia (BG <4.0 mmol/L) was significantly lower (0.6% vs 2.1%), with very few instances of severe hypoglycaemia (BG <2.6 mmol/L).
- Results indicate superior glycaemic control and reduced hypoglycaemia compared to literature data from intensive insulin therapy protocols.
Conclusions:
- Model-based control protocols, such as STAR-GRYPHON, can safely and effectively manage blood glucose in very premature infants.
- These protocols should be utilized in future studies to investigate the clinical outcomes of insulin therapy in neonates.
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.
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