Plain English Summary
Background and study aims
Both high and low blood sugar (glucose) 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 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. Our previous study investigated 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. We are now expanding upon this, developing and running a study to compare rCGM with standard care. The aim is to determine if rCGM with a new paper-based algorithm can help improve glucose control, is clinically acceptable, and is safe in these preterm infants.
Who can participate?
Pre-term babies within 24 hours of birth and with a birth weight <1200g
What does the study involve?
Participating babies are randomly allocated to either have rCGM with a paper-based algorithm to guide sugar control, or standard care with glucose monitored but with data hidden from the clinical team. The intervention is for the first week of their life. The percentage of time that blood glucose is in the target range is measured.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Addenbrooke's Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2015 to August 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Catherine Guy
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18826
Study information
Scientific title
Real time continuous glucose monitoring in neonatal intensive care: a randomised controlled trial
Acronym
REACT RCT
Study hypothesis
The aim of this study is to determine if 'real time continuous glucose monitoring’ (rCGM) with a new paper based algorithm can help improve glucose control and is clinically acceptable and safe for preterm infants.
Ethics approval
15/EE/0158
Study design
Randomised; Interventional; Design type: Diagnosis
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
Insertion and removal of sensor (replacements may be necessary)
Study Entry : Registration and one or more randomisations
Intervention type
Device
Phase
Drug names
Primary outcome measure
Percentage of time sensor glucose in target of 2.6-10mmol/l within the first 6 days of life in preterm infants
Secondary outcome measures
1. Efficacy
2. Acceptability
3. Safety
4. Health economics
Overall trial start date
03/08/2015
Overall trial end date
04/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parental consent
2. Less than or equal to 1200g birth weight
3. Less than or equal to 24 hours of age
4. Less than or equal to 33+6 weeks gestation
5. Male & Female
6. Upper Age Limit 1 days; Lower Age Limit 1 days
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 120
Participant exclusion criteria
1. A lethal congenital abnormality known at trial entry
2. Any congenital metabolic disorder known at trial entry
3. Neonates who, in the opinion of the treating clinician at trial entry, have no realistic prospect of survival
Recruitment start date
03/08/2015
Recruitment end date
04/08/2017
Locations
Countries of recruitment
Netherlands, Spain, United Kingdom
Trial participating centre
Addenbrooke's Hospital (co-coordinating centre)
University Department of Paediatrics
University of Cambridge
Box 116
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Addenbrooke’s Hospital
Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Organisation
University of Cambridge (UK)
Sponsor details
Research Operations Office
Research Services Division
University of Cambridge
16 Mill Lane
Cambridge
CB2 1SB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29866729