Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/05/2015
Date assigned
15/05/2015
Last edited
15/06/2016
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 <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

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

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 measures

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

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

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/06/2016: Plain English summary added.