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.
Abstract

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