Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/05/2015
Date assigned
15/05/2015
Last edited
21/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://paediatrics.medschl.cam.ac.uk/research/clinical-trials/real-time-continuous-glucose-monitoring-newborn-react/

Contact information

Type

Public

Primary contact

Mrs Catherine Guy

ORCID ID

Contact details

University Department of Paediatrics
University of Cambridge
Box 116
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom

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

30/11/2018

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

www.cuh.org.uk

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/

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

Further publications are planned to be submitted to a high-impact peer reviewed journal one year after trial ending.

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

Not expected to be available

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29866729

Publication citations

Additional files

Editorial Notes

21/09/2018: The following changes have been made: 1. The overall trial start date has been changed from 03/08/2015 to 01/01/2012. 2. The overall trial end date has been changed from 04/08/2017 to 31/07/2019. 3. The ethics committee name and date have been added. 4. The interventions have been changed. 5. The public title has been changed from "Real time continuous glucose monitoring in neonatal intensive care" to "Can a glucose sensor improve control of sugar levels of premature babies in intensive care?". 6. The publication and dissemination plan and intention to publish date have been added. 7. The IPD sharing statement has been added. 8. The plain English summary has been updated to reflect the changes to the overall trial dates. 18/09/2018: The following changes have been made: 1. The IRAS number has been added. 2. "UK Sample Size: 120" has been removed from the target number of participants. 3. The recruitment start date has been changed from 03/08/2015 to 04/07/2016. 4. The recruitment end date has been changed from 04/08/2017 to 30/11/2018. 5. The trial website has been added. 06/06/2018: Publication reference added. 15/06/2016: Plain English summary added.