Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/03/2020
Date assigned
01/04/2020
Last edited
01/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Gestational diabetes (GDM) is a common pregnancy-related condition which causes high blood glucose (sugar) levels and increases the risk of damaging effects for both mother and baby. The prevalence of GDM has increased by about a third over the past decade, and this is mainly explained by an increase in obesity. GDM is usually diagnosed at 24-28 weeks of pregnancy and little is known about blood glucose levels in early pregnancy. Although preventing GDM is recognised as a priority by Diabetes UK, the most effective strategies have yet to be identified.
In Oxford, a remote monitoring digital application called GDm-Health™ has been developed. GDm-HealthTM supports management of GDM by a smart phone app that automatically transmits blood glucose measurements to a secure web site and allows for communication between healthcare professionals and women with GDM via texts. This system is clinically reliable and highly satisfactory to women with GDM, but has only been proven in women in later pregnancy with a confirmed diagnosis of GDM. The researchers are interested in applying this technology earlier in pregnancy to investigate its usefulness for prevention or earlier detection and management of GDM. However, asking women to test blood glucose levels before a formal diagnosis may be challenging and for this reason the researchers intend to conduct a qualitative study asking women for their opinions about this.

Who can participate?
Female, aged 18 years or above, in the first trimester of pregnancy, and at risk of GDM.

What does the study involve?
The researchers intend to recruit 40 women at risk of developing GDM at their routine 12-week nuchal scan and invite them to take part in a recorded interview that lasts approximately 30 minutes. The researchers will ask a series of open questions about blood testing and strategies for GDM prevention, including diet and physical activity, transcribe the interviews and apply thematic analysis.

What are the possible benefits and risks of participating?
It is likely that there is little apparent benefit for women taking part in this study, although some may feel better knowing they are contributing to other women’s well-being in the future. Women may also appreciate being able to discuss their personal challenges and having their opinions sought. Some women may feel distress when asked to discuss personal feelings and opinions.

Where is the study run from?
John Radcliffe Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2020 to March 2021

Who is funding the study?
NIHR Oxford Biomedical Research Centre (UK)

Who is the main contact?
Dr Pamela Dyson (public), pamela.dyson@ocdem.ox.ac.uk
Dr Lucy MacKillop (scientific), Lucy.Mackillop@ouh.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Dyson

ORCID ID

http://orcid.org/0000-0001-5391-6301

Contact details

OCDEM
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
+44 (0)1865 857349
pamela.dyson@ocdem.ox.ac.uk

Type

Scientific

Additional contact

Dr Lucy MacKillop

ORCID ID

http://orcid.org/0000-0002-1927-1594

Contact details

The Women's Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 851165
Lucy.Mackillop@ouh.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.3, IRAS 270870

Study information

Scientific title

p-GDm: A qualitative study of pregnant women's attitudes and willingness to engage with interventions to prevent gestational diabetes

Acronym

p-GDm

Study hypothesis

Women at risk of gestational diabetes would be willing to engage with preventative measures, including blood glucose monitoring, dietary and physical activity interventions in early pregnancy and before a formal diagnosis of gestational diabetes

Ethics approval

Approval pending, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 20/WS/0054

Study design

Qualitative study

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request participant information sheet

Condition

Gestational diabetes

Intervention

Women at risk of gestational diabetes will be recruited from the nuchal screening clinic and invited to take part in a recorded face-to-face structured interview. Each interview will take 30-40 minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Women's willingness to engage with blood glucose monitoring and dietary and physical activity interventions in early pregnancy assessed using qualitative interviews analysed with thematic analysis

Secondary outcome measures

Assessed by qualitative interview analysed with thematic analysis:
1. Acceptability of:
1.1. Being informed they are a high risk of GDM
1.2. Testing blood glucose levels before a formal diagnosis of GDM
1.3. Different interventions to reduce the risk of GDM
2. Use of technology:
2.2. Blood glucose meters
2.3. App
3. Feedback:
3.1. Blood glucose levels
3.2. Text messages

Overall trial start date

01/06/2019

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study.
2. Female, aged 18 years or above
3. First trimester of pregnancy
4. At risk of GDM, assessed by one of the following:
4.1. Pre-pregnancy obesity (BMI>30kg/m²)
4.2. Previous diagnosis of GDM
4.3. Previous large baby (birth weight >4.5kg)
4.4. A first-degree relative with diabetes
4.5. Belonging to a high-risk ethnic group (South Asian, Chinese, Afro-Caribbean or Middle Eastern)

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Severe congenital anomaly found on ultrasound
2. Planned termination
3. Significant pre-pregnancy comorbidity including renal failure, severe liver disease, organ transplant, cardiac failure, psychiatric conditions requiring in-patient admission, history of eating disorder
4. Diagnosed diabetes or gestational diabetes
5. Hyperemesis gravidarum
6. Unable to understand English

Recruitment start date

01/04/2020

Recruitment end date

31/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Women's Centre
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford University Hospitals NHS Trust

Sponsor details

Joint Research Office
Second floor OUH Cowley
Unipart House Business Centre
Garsington Road
Oxford
OX4 2PG
United Kingdom
+44 (0)1865 572386
ouh.sponsorship@ouh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.ouh.nhs.uk/research/contact-us.aspx

Funders

Funder type

Government

Funder name

NIHR Oxford Biomedical Research Centre

Alternative name(s)

NIHR Biomedical Research Centre, Oxford, OxBRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Results and Publications

Publication and dissemination plan

This study is designed to inform our future research into the prevention of gestational diabetes and the results will therefore be published in an internal report.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

01/04/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/03/2020: Trial’s existence confirmed by West of Scotland REC 5. Due to current public health guidance, recruitment for this study has been paused.