Can a glucose sensor improve control of sugar levels of premature babies in intensive care?
| ISRCTN | ISRCTN12793535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12793535 |
| IRAS number | 168042 |
| Secondary identifying numbers | CRN 18826, IRAS 168042 |
- Submission date
- 14/05/2015
- Registration date
- 15/05/2015
- Last edited
- 15/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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?
Dr Kathryn Beardsall
kb274@medschl.cam.ac.uk
Contact information
Public
Consultant Neonatologist
University of Cambridge Department of Paediatrics
Box 116 Level 8
Addenbrookes Hospital
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0003-3582-183X |
|---|---|
| Phone | +44 (0)7565964631 |
| kb274@medschl.cam.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Diagnosis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Real time continuous glucose monitoring in neonatal intensive care: a randomised controlled trial |
| Study acronym | REACT RCT |
| Study objectives | 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(s) | NRES Committee East of England - Cambridge Central, 28/07/2015, 15/EE/0158 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2012 |
| Completion date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200 |
| Total final enrolment | 182 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/07/2016 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- England
- Netherlands
- Spain
- United Kingdom
Study participating centre
University of Cambridge
Box 116
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Addenbrooke’s Hospital
Box 277
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | www.cuh.org.uk |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
University/education
Research Operations Office
Research Services Division
University of Cambridge
16 Mill Lane
Cambridge
CB2 1SB
England
United Kingdom
| Website | www.admin.cam.ac.uk/offices/research/ |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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 the publication of the primary results and will be available for 25 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/06/2018 | Yes | No | |
| Results article | results | 01/04/2021 | 15/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/02/2021: Publication reference and total final enrolment added.
02/02/2021: Contact details updated.
11/12/2018: The following changes were made:
1. The participant-level data was updated.
2. The IPD sharing statement was updated.
06/12/2018: The recruitment end date has been changed from 30/11/2018 to 31/12/2018.
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.
