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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Corinne Collett
-
C.Collett@uea.ac.uk


Prof Eleanor Scott
+44 (0)113 343 7762
E.M.Scott@leeds.ac.uk


Prof Helen R Murphy
+44 (0)1603 591657
Helen.Murphy@uea.ac.uk


Dr Study Team
-
protect.trial@uea.ac.uk


Study Location:

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Be Part of Research - Trial Details - Continuous glucose monitoring amongst pregnant women with early-onset type 2 diabetes
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Continuous glucose monitoring amongst pregnant women with early-onset type 2 diabetes

Recruiting

Open to: Female

Age: Adult

Oxford Sheffield London Leeds Manchester Leicester Norwich London Birmingham London Milton Keynes Derby London Huddersfield Bradford Isleworth London Watford Liverpool Thornton Heath London

Medical Conditions

Early-onset type 2 diabetes in pregnancy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Previous studies have shown that Continuous Glucose Monitoring (CGM) improves maternal glucose, reduces neonatal admissions and is clinically and cost-effective in type 1 diabetes (T1D) pregnancy, and as a result CGM is now standard care in T1D pregnancy. However, there are no well-designed adequately powered trials to compare CGM and standard care monitoring of blood glucose in type 2 diabetes (T2D) pregnancy.

The purpose of this study is to examine whether using CGM improves glucose levels in pregnant women with T2D and whether it leads to better outcomes for the baby. We will also look at its impact on maternal wellbeing, diabetes treatment satisfaction, and cost effectiveness.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2024 28 Feb 2026

Eligible participants will be approached early in pregnancy and if consent is given they will be enrolled. All participants will wear a masked sensor for 7-14 days to collect baseline CGM data. Participants will then be randomly allocated to receive either study CGM or the current standard of care (fingerprick blood glucose monitoring, or continuous glucose monitoring) for the rest of pregnancy.

Study visits are aligned with routine antenatal visits every 4 weeks. A blood sample for metabolic phenotyping will be obtained at the recruitment visit. The participant will be asked to complete questionnaires at the recruitment visit and then again at around 32 weeks' gestation. Blood samples for HbA1c will be taken at baseline, 28-week, 32-week, and 36-week visits. Participants in the control arm will wear a masked sensor for 14 days at 20, 28, 32 and 36 weeks' gestation. Following delivery we will collect information on birth and infant. 20-25 participants will also be interviewed at baseline and around 32-36 weeks' gestation to examine, among other things, barriers and facilitators for CGM use in this population.


We are aiming to recruit 422 pregnant women aged 16 years and above with T2D.

You can take part if:



You may not be able to take part if:


1. Non-type 2 diabetes2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min)3. Severe visual impairment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford University Hospitals NHS Foundation Trust
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Northern General Hospital Herries Road
    Sheffield
    S5 7AU
  • University College London Hospitals NHS Foundation Trust
    250 Euston Road
    London
    NW1 2PG
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • Manchester University NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • University Hospitals of Leicester NHS Trust
    Leicester Royal Infirmary Infirmary Square
    Leicester
    LE1 5WW
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • Birmingham Women's and Children's NHS Foundation Trust
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Barts Health NHS Trust
    The Royal London Hospital 80 Newark Street
    London
    E1 2ES
  • Milton Keynes University Hospital NHS Foundation Trust
    Standing Way Eaglestone
    Milton Keynes
    MK6 5LD
  • University Hospitals of Derby and Burton NHS Foundation Trust
    Royal Derby Hospital Uttoxeter Road
    Derby
    DE22 3NE
  • Chelsea and Westminster Hospital NHS Foundation Trust
    Chelsea & Westminster Hospital 369 Fulham Road
    London
    SW10 9NH
  • Calderdale and Huddersfield NHS Foundation Trust
    Trust Headquarters Acre Street Lindley
    Huddersfield
    HD3 3EA
  • Bradford Teaching Hospitals NHS Foundation Trust
    Bradford Royal Infirmary Duckworth Lane
    Bradford
    BD9 6RJ
  • West Middlesex University Hospital
    Twickenham Road
    Isleworth
    TW7 6AF
  • Guy's and St Thomas' NHS Foundation Trust
    St Thomas' Hospital Westminster Bridge Road,
    London
    SE1 7EH
  • West Hertfordshire Teaching Hospitals NHS Trust
    Trust Offices Watford General Hospital Vicarage Road
    Watford
    WD18 0HB
  • Liverpool Women's NHS Foundation Trust
    Liverpool Womens Hospital Crown Street
    Liverpool
    L8 7SS
  • Croydon Health Services NHS Trust
    Croydon University Hospital 530 London Road
    Thornton Heath
    CR7 7YE
  • Newham University Hospital NHS Trust
    Newham General Hospital Glen Road
    London
    E13 8SL

None

Prof Eleanor Scott
+44 (0)113 343 7762
E.M.Scott@leeds.ac.uk


Dr Study Team
-
protect.trial@uea.ac.uk


Prof Helen R Murphy
+44 (0)1603 591657
Helen.Murphy@uea.ac.uk


Ms Corinne Collett
-
C.Collett@uea.ac.uk



The study is sponsored by University of East Anglia and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC).



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Read full details for Trial ID: ISRCTN12804317

Or CPMS 58352

Last updated 01 November 2023

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