Improving uptake of screening for type 2 diabetes after a diagnosis of gestational diabetes in pregnancy: is a home blood test the answer?
| ISRCTN | ISRCTN11690627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11690627 |
| IRAS number | 356021 |
| Secondary identifying numbers | AC25046 |
- Submission date
- 18/09/2025
- Registration date
- 24/09/2025
- Last edited
- 22/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Gestational diabetes mellitus (GDM) is the name for diabetes that develops in pregnancy. It is recommended that all women with GDM have a follow-up blood test after delivery to check that their blood sugars are normal. This blood test is called an ‘HbA1c’ and it is normally taken around 13 weeks after their baby is born, to make sure that blood sugars have normalised. This is important as a small number of women will have high blood sugars which may indicate that they have type 2 diabetes or are at high risk of developing this in the near future.
People who have GDM, are ten times more likely to go on to develop type 2 diabetes at some point in their lives. For this reason it is also recommended that people with a history of GDM have their HbA1c level taken once a year.
At the moment women with GDM are invited to attend a clinic to have this blood test done. Although this is the correct test to screen for type 2 diabetes, we know that some women struggle to attend these appointments and therefore do not have their blood level checked. This study is trialling a HbA1c blood test which is taken at home, to see if it improves the number of people who have HbA1c testing after a pregnancy affected by GDM. We also hope to gain an understanding of how people feel about doing an at-home test, rather than visiting a clinic for one, in order to assess whether at home tests might provide an alternative to in-clinic testing for NHS patients in the future.
Who can participate?
Patients aged 16 to 55 years with gestational diabetes having their antenatal care in NHS Lothian
What does the study involve?
Around 13 weeks after delivery the research team will send participants a HbA1c blood testing kit in the post to do at home. This kit will need to be returned via a post box. Participants will be sent one reminder to carry out the blood test at around 15 weeks postpartum. As the home test replaces the in-person test usually taken in clinic should a participant not return the home blood test by 16 weeks postnatal they will be sent an appointment to attend clinic to have it performed.
The home blood test involves using a very small handheld needle device to prick the finger in order to collect around 5-6 drops of blood in a small bottle. After taking the blood, the kit instructions will be sent by tracked post back to the laboratory who will analyse it.
The home blood test kit is not provided and analysed by the NHS. It is provided by a third party company (Forth, a trading name of Humankind Ventures Ltd, https://www.forthwithlife.co.uk). This company and the labs analysing the samples meet all the necessary standards to process participant samples accurately and securely.
If participants choose to do the home blood test, their result will be sent to them by the research team in the post. They will also be asked to complete an online survey to help the team understand their experiences of the home testing kit. Test results will also be shared with participants' GPs. If out with normal range the result will be shared with the NHS Lothian diabetes team, who will arrange a follow-up appointment.
What are the possible benefits and risks of participating?
Participants may or may not find it more convenient to take their postnatal HbA1c test at home. There are otherwise no direct benefits to taking part in this study, but the results from this study might help to improve the healthcare of patients in the future.
Where is the study run from?
The study is run by the Edinburgh Pregnancy Research Team at the University of Edinburgh. They are currently based within the Royal Infirmary of Edinburgh (UK).
When is the study starting and how long is it expected to run for?
February 2025 to June 2027
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Rebecca Reynolds, r.reynolds@ed.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre for Cardiovascular Science - University of Edinburgh
47 Little France Crescent
Edinburgh BioQuarter
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 (0)131 242 6762 |
|---|---|
| R.Reynolds@ed.ac.uk |
Study information
| Study design | Prospective single-arm pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Hospital |
| Study type | Screening |
| Participant information sheet | 48022_PIS.pdf |
| Scientific title | MyGDM Scotland: Home HbA1c Testing Pilot |
| Study objectives | Primary Objectives: 1. To assess patient uptake of home HbA1c testing for type 2 diabetes screening in a 3 – 4-month postpartum population diagnosed with gestational diabetes during pregnancy. Secondary Objectives: 1. To measure participant satisfaction with home HbA1c testing for type 2 diabetes screening in the postnatal period. 2. To gather participant views regarding postnatal type 2 diabetes screening and possible modifications to follow-up care to optimise uptake. 3. To gather data on trial recruitment rates and factors affecting recruitment to this pilot trial to guide sample size calculations and study design decisions prior to undertaking a larger clinical trial. |
| Ethics approval(s) |
Approved 17/06/2025, South Central -Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048029; berkshireb.rec@hra.nhs.uk), ref: 25/SC/0162 |
| Health condition(s) or problem(s) studied | Screening for type 2 diabetes in patients with a history of gestational diabetes |
| Intervention | Participants will be sent a HbA1c blood testing kit in the post to do at home rather than attending an in-person clinic appointment. The home blood test involves using a small handheld needle device to collect around 5-6 drops of blood into a small bottle. After taking the blood, participants will send it by tracked post back to the laboratory that will analyse it. The blood test result will be sent to participants by the research team in the post and participants will be asked to complete a short online survey to help the team understand their experience of the home testing kit. |
| Intervention type | Other |
| Primary outcome measure | The proportion of total trial participants who return their completed home HbA1c test to the lab for analysis and receive their HbA1c test result, therefore completing postnatal type 2 diabetes screening. Assessed between 13-16 weeks following the end of pregnancy for each participant; final outcome calculated upon trial completion. |
| Secondary outcome measures | 1. Participant satisfaction with the home HbA1c screening test used for postpartum type 2 diabetes screening, measured using quantitative and qualitative participant survey data at 13-16 weeks following the end of pregnancy for each participant 2. Participant views regarding optimising postnatal screening for type 2 diabetes following a diagnosis of gestational diabetes, collected via participant survey data at 13-16 weeks following the end of pregnancy for each participant 3. The number of patients approached for recruitment into the trial, subsequent trial recruitment rates and reasons participants not recruited, collected via trial pre-screening log at trial completion |
| Overall study start date | 17/02/2025 |
| Completion date | 01/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged 16 to 55 years 2. Under the care of NHS Lothian 3. Diagnosed with Gestational Diabetes this pregnancy as per NHS Lothian guidelines 4. Deemed suitable for postpartum HbA1c testing by the clinical team 5. Able to speak/read/understand a language for which translated documents can be obtained by the research team |
| Key exclusion criteria | 1. Aged under 16 years old 2. Classified as an Adult with Incapacity (AWI) as determined by the clinical or research team 3. Deemed unsuitable for postpartum HbA1c testing by the clinical team 4. Unable to speak/read/understand a language for which translated documents can be obtained by the research team |
| Date of first enrolment | 14/08/2025 |
| Date of final enrolment | 01/02/2027 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Sponsor information
University/education
Usher Building
5-7 Little France Road
Edinburgh BioQuarter - Gate 3
Edinburgh
EH16 4UX
Scotland
United Kingdom
| Phone | +44 (0)131 242 9139 |
|---|---|
| resgov@accord.scot | |
| Website | https://www.ed.ac.uk |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The dataset generated during the current study is not expected to be made available due to the small sample size (n = 30) and pilot nature of the data which would make reidentification likely. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/09/2025 | No | Yes |
Additional files
Editorial Notes
18/09/2025: Study's existence confirmed by South Central -Berkshire B Research Ethics Committee.
