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 of 1200 g or lower.
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?
January 2012 to July 2019
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
CRN 18826, IRAS 168042
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
NRES Committee East of England - Cambridge Central, 28/07/2015, 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
Updated interventions as of 21/09/2018:
Eligible babies are randomised within 24 hours of age through TENALEA (web based randomisation program) using a 1:1 ratio to either the treatment arm or the control arm.
Intervention Arm: Real-time continuous glucose monitoring (rCGM) with paper-based algorithm. A glucose sensor is inserted to transmit data to real-time continuous glucose monitor to support clinical management for up to 6 days. The sensor is removed on day 7.
Control Arm: Standard clinical management with continuous glucose monitoring data blinded to the clinical team. A glucose sensor is inserted to collect blinded data using continuous glucose sensor for up to 6 days. The sensor is removed on day 7.
Follow up for both arms:
Day 14
Sensor site checked
Clinical details recorded including length, weight and head circumference
At 36 weeks corrected gestation
Assessment of resource used and clinical details recorded including length, weight and head circumference.
Previous interventions:
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
01/01/2012
Overall trial end date
31/07/2019
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
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
04/07/2016
Recruitment end date
31/12/2018
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
www.admin.cam.ac.uk/offices/research/
Organisation
Cambridge University Hospitals NHS Foundation Trust
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Further publications are planned to be submitted to a high-impact peer reviewed journal one year after trial ending.
IPD sharing statement as of 11/12/2018:
Data applications need to be made to Dr Kathryn Beardsall, Chief Investigator (kb274@medschl.cam.ac.uk). The type of data available is anonymised CRF data and continuous glucose monitoring (CGM) data. The data will become available after publication of primary results and will be available for 25 years.
Previous IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29866729