Thank you again to all the families and staff for your support in making this study possible.

We are now exploring other ways to improve technology to care for babies in NICU.

If you would be interested to be contacted about follow up studies or could provide parental perspectives to drive research please do get in touch.

Background

Both high and low blood sugar levels are common in preterm babies and this has been linked with poor outcome. One of the difficulties of managing sugar levels in preterm babies is that it involves a sample of blood being taken and as clinical teams try to avoid disturbing babies there is often a long time between measurements. There is now a device ‘real time continuous glucose monitoring’ (rCGM) that is used by some children and adults with diabetes which can provide data on glucose (sugar) levels continuously. This involves a small sensor being placed under the skin but it can be left there for up to a week and allows the medical team to respond quickly and treat changes in sugar levels to keep the sugar level within a normal range. Video Link.

Study Design

The REACT study will be divided into 3 stages:

Stage 1: The feasibility study based at Addenbrooke’s Hospital, Cambridge will assess how easy it is to use rCGM in a neonatal intensive care setting, and what impact it has on the number of blood tests babies have. The study results will help design the best way to undertake a larger clinical trial and test whether in the future the rCGM device should be used as part of standard clinical care.

Stage 2: This stage will be a randomised clinical trial and run in 5 hospitals, in which 200 babies will be randomised (divided by chance), between 2 study groups. One group will get standard clinical care; the other group will also have rCGM to help support the management of sugar levels. The main aim is to see if using the rCGM can reduce how often and for how long preterm babies have very high or very low sugar levels.

Stage 3: This stage involves combining the large amount of data from the rCGM with a computer program that can guide on the best treatment of sugar levels. This is only a small study. It aims to test how well the computer algorithm (a set of instructions which tell the computer how to perform a specific task) can provide a guide to help with sugar control for individual babies. This study will take place in Addenbrooke’s Hospital, Cambridge.

Clinical Impact

By preventing both high and low sugar levels this intervention could improve the way we care for these preterm babies who have a unique physiology. As well as helping with the short term care of these babies targeting sugar levels may improve growth and long term health and neurodevelopment.

Eligibility for REACT

• Parental informed consent
• Less than 48 hours of age
• Neonates weighing less than 1200g

Exclusion from REACT

• Major congenital malformation
• Underlying metabolic disorder
• Neonates who, in the opinion of the treating clinician, have no realistic prospect of survival

Coordination and Sponsorship

This 3-stage study will be coordinated from the University Department of Paediatrics at the University of Cambridge and is sponsored jointly by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.

Key Publications

• Beardsall K, Thomson L, Guy C, Iglesias-Platas I, van Weissenbruch MM, Bond S, et al. Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial. The Lancet Child & Adolescent Health. 2021 Apr;5(4):265-73.
• Petrou S, Kim S, Bond S, Allison A, Beardsall K. Cost-effectiveness of real time continuous glucose monitoring to target glucose control in preterm infants. Seminars in Perinatology. 2021 Jan:151392.
• Beardsall K, Thomson L, Elleri D, Dunger DB, Hovorka R. Feasibility of automated insulin delivery guided by continuous glucose monitoring in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 May;105(3):279-84.
• Thomson L, Elleri D, Bond S, Howlett J, Dunger DB, Beardsall K. Targeting glucose control in preterm infants: pilot studies of continuous glucose monitoring. Arch Dis Child Fetal Neonatal Ed. 2018 Sep 19:fetalneonatal-2018-314814.

Contact Details

If you would like to contact the trial team, please email REACT@paed.cam.ac.uk or telephone 01223 746414.

Further information can be found here

 

 

 

 

The REACT study is supported by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.