REACT RCT
Research type
Research Study
Full title
Real Time Continuous Glucose Monitoring in Neonatal Intensive Care
IRAS ID
168042
Contact name
Kathryn Beardsall
Contact email
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Both high and low blood sugar levels are common in preterm babies and this has been linked with poor outcome. Managing these sugar levels in preterm babies is difficult as individual babies respond very differently to treatment and checking sugar levels currently involves taking blood samples. Clinical teams try to avoid taking blood samples and there can therefore be a relatively long time between taking measurements. In contrast other physiological parameters like blood pressure and levels of oxygen are measured continuously. There is now a device ‘real time continuous glucose monitoring’ (rCGM) that is used by some children and adults with diabetes which can provide continuous data on sugar levels. 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.
The REACT feasibility study assessed how easy it was to use rCGM in a neonatal intensive care setting and the impact it had on the number of blood tests babies have. These results have helped design this randomized control trial to test whether in the future the rCGM device could be used as part of standard clinical care.
This study is an international randomised controlled trial that will recruit 200 pre-term babies within 24 hours of birth and with a birth weight <1200g. Babies will either have rCGM with a paperbased algorithm to guide sugar control or standard care with glucose monitored but with data blinded to the clinical team. The intervention is for the first week of their life. The aim is to determine if rCGM with a new paperbased algorithm can help improve glucose control, is clinically acceptable and safe in these preterm infants.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0158
Date of REC Opinion
28 Jul 2015
REC opinion
Further Information Favourable Opinion