CLINICAL RESULTS FROM A GLYCAEMIC CONTROL PROTOCOL IMPLIMENTATION IN NEONATAL CARE JL Dickson1, AM Lynn2, AJ LeCompte1, T Desaive3, B Benyó4, JG Chase1 1University of Canterbury, Department of Mechanical Engineering, New Zealand 2Chrischurch Women's Hospital, Neonatal Intensive Care Unit, New Zealand 3University of Liege, GIGA-Cardiovascular Sciences, Belgium 4Budapest University of Technology and Economics, Hungary Abstract Hyperglycaemia is associated with increased mortality and morbidity in neonatal intensive care. STAR-GRYPHON is a model-based glycaemic control protocol, which uses insulin sensitivity to tailor insulin treatments to patients and changing patient condition. It is implemented as a standard of care in a neonatal intensive care unit in Christchurch, New Zealand. Keyword(s): physiological modelling - clinical engineering 1. Introduction High blood glucose (BG), hyperglycaemia, in the neonatal intensive care unit (NICU) affects 3070% of extremely premature infants (gestational age ≤ 27 weeks), and is associated with increased risk of infection, ventilator dependence, hospital length of stay and mortality. Increasingly, evidence suggests that controlling the blood sugar levels to a normal range can prevent and reduce the extent of morbidities, thus improving patient outcomes and reducing the costs of care. STAR-GRYPHON (Stochastic TARgeted Glycaemic Regulation sYstem to Prevent Hyperand hypO-glycaemia in Neonates) is a modelbased protocol for dosing insulin in very premature infants. It is currently being used as a standard of care in Christchurch (CCH), New Zealand (NZ). It is also being implemented in Miskolc, Hungary, and as part of a randomized trial in Auckland (NZ). Presented here are clinical results from its use in CCH. 2. Model based control Mathematical models of glucose-insulin physiology are used. Inter-patient variability is managed directly by identifying insulin sensitivity from data available at the bedside. Prediction of future sensitivity values using cohort based statistical modelling allows likely BG outcomes to be forecast for a given treatment. Typically, treatments are selected such that the risk of BG<4.4 mmol/L is 5%, maximising likelihood of outcomes in the target range of 4.0-8.0 mmol/L. 2.3 Implementation STAR-GRYPHON is implemented on a tablet computer interface, designed in conjunction with clinical staff. Starting criteria for insulin is two consecutive BG>10 mmol/L in 4-6 hrs. 3. Results STAR-GRYPHON achieves more BG within the clinically targeted range than retrospective data, with much less hypoglycaemia, which can also be dangerous. Table 1: Clinical results, with comparison to retrospective data. Retrospective STAR-GRYPHON Patient Cohort # Episodes 25 13 GA (weeks) 27 [25-27] 26 [25-27] Weight (g) 845 [800-900] 925 [750-1030] PNA (days) N/A 3 [1.5-3.5] Clinical interventions Meas. intrvl. (hr) 3.2 [2.6 - 3.9] 4.0 [3.9-4.1] Insulin (U/kg/hr) 0.03 [0.02-0.06] 0.05 [0.04 -0.07] Performance Median BG 7.8 [6.6- 9.1] 6.9 [6.2-7.8] % BG in range 51.9 79.4 % BG>10 16.3 4.0 Safety % BG<4.0 2.1 0.1 % BG<2.6 0.1 0 # episodes with 1 (4) 0 (0) BG <2.6 All BG units are mmol/L. Data given as median [IQR]. GA is gestational age, PNA is post-natal age. 4. Summary STAR-GRYPHON is a model-based glycaemic control protocol for neonatal intensive care. Results show it to be very safe and effective. 13th Belgian Day on Biomedical Engineering – joint meeting with IEEE EMBS Benelux Chapter November 28, 2014