Randomised Controlled Trial of Real Time Continuous Glucose Monitoring in Neonatal Intensive Care REACT

Background: Hyperglycaemia is common in the very preterm infant and has been associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia has proved challenging. The development of real time continuous glucose monitors (rCGM) to inform treatment decisions provides an opportunity to reduce this risk. We aimed to assess the feasibility of rCGM combined with a specifically designed paper based guideline to target glucose control in the preterm infant. Methods: The REACT Randomised controlled Trial (Real Time Continuous Glucose Monitoring in Neonatal Intensive Care) is an international multicentre randomised controlled trial. Two hundred preterm infants ≤1200g, and ≤24 hours of age will be randomly allocated to either real time continuous glucose monitoring, or standard care (with blinded CGM data collection). The primary outcome is time in target 2.6-10mmol/l during the study intervention assessed using continuous glucose monitoring. Secondary outcomes include efficacy relating to glucose control, utility including staff acceptability, safety outcomes relating to incidence and prevalence of hypoglycaemia and health economic analyses. Ethics and Dissemination: The REACT Trial has been approved by the NHS Health Research Authority National Research Ethics Service Committee East of England – Cambridge Central; Medical Ethics Review Committee, VU University Medical Centre, Amsterdam, The Netherlands and the Research Ethics Committee, Sant Joan de Déu Research Foundation, Barcelona, Spain. Recruitment began in July 2016 and will continue until mid 2018. Dissemination plans include presentations at scientific conferences, scientific publications and efforts at stakeholder engagement. Trial Registration The Trial has been adopted by the National Institute of Health Research Clinical Research Network portfolio (ID: 18826) and is registered with the ISRCTN registry (ID: 12793535).The study is funded by NIHR: Evaluation, Trials and Studies Programme. Further support was provided by Medtronic for supplying MiniMed® 640G System, Enlite® sensors and Guardian™ Link transmitters and Novobiomedical provided all point of care equipment and training for glucose, lactate and ketone measurement. The trial is jointly sponsored by Cambridge University Hospitals NHS Foundation Trust and University of Cambridge