Digital clinical diagnostics and diabetes home testing provider Digostics and University Hospital Southampton NHS Foundation Trust (UHS) have established a partnership that will see expectant mothers under the care of UHS maternity services become the first, anywhere in the world, to access new, ground-breaking remote testing technology designed to improve screening for gestational diabetes mellitus (GDM). The collaboration involves a pilot introduction of the only regulatory-approved home-use oral glucose tolerance test (OGTT) testing-solution, GTT@home, developed by Digostics.

Key aims of the collaboration include improving equity of access to healthcare by eliminating barriers associated with in-clinic testing that can be felt more acutely within specific at-risk patient. To support this, Digostics is creating multilingual home-user support.

“We hope this revolutionary new at-home test is going to dramatically change the way we deliver gestational diabetes testing during antenatal care,” said Matthew Coleman, Consultant Obstetrician, UHS. “Not only is it better for the patients to self-test in the convenience of their own home, cutting down the number of antenatal appoint­ments they attend, but it will also free up precious NHS time and resources.”

GTT@home achieved UKCA and CE market authorisation in 2022, becoming the first and only regulatory approved alternative to the in-clinic OGTT. A first phase pilot of GTT@home involving a small caseload of patients was conducted with UHS in November 2022. This announcement reflects the move to a higher volume second-phase project designed to prove the service’s overall effectiveness.

According to the International Diabetes Federation, up to 20% [1] of UK pregnancies are impacted by GDM, with background risk factors [2] including the age, ethnicity and body mass index of the expectant mother. Left undiagnosed or untreated, GDM can lead to perinatal complications such as foetal macrosomia (larger than average babies) that warrant unscheduled or even emergency changes to the birth-plan to protect both mother and baby. Additionally, 50% [3] of women experiencing GDM can go on to develop type 2 diabetes (T2D) within 10 years. The condition also confers an 8-fold [4] increase for the child of developing T2D in adulthood. Prompt identification of GDM is key.

“Digostics is excited to work with UHS to explore how GDM screening can be streamlined through home-testing,” said James Jackson, CEO and Founder, Digostics. “Our aim is to demonstrate how we can transform diabetes detection in pregnancy by taking the OGTT to the expectant mother, resulting in increased test uptake, reductions in test overheads for healthcare providers and the earlier return of GDM diagnoses.”

The OGTT – a fasting test involving an initial blood test, the immediate consumption of a glucose drink and then a second blood test after a two hour wait – is the only recommended test for detecting GDM. However, as the OGTT is currently offered only in-clinic, the inconvenience for patients and the provisioning challenges posed for healthcare providers frequently constrains test throughput and can lead to delayed testing.

“From the admin resources it takes to book and manage clinics, the clinical time taken to run the service and the clinic space taken, this can all now be done
with a simple test at home using the GTT@home kit,” added Matthew Coleman. “In addition, patients are able to test at the earliest opportunity, meaning fewer delays and, if gestational diabetes is detected, they can be treated and managed quickly helping to keep them and their babies safe.”

The GTT@home service is based on a simple-to-use home test kit containing the novel GTT@home test device, a glucose drink and finger prickers. The test kit is mailed to the expectant mother at the time the test is due. Easy to follow instructions, online guidance and telephone support ensure that the test can be completed conveniently at home on the day of choice. When completed, the user can immediately send their test data to their care team by scanning a snap-off fob attached to the test device with a smartphone using the GTT@home mobile app.

The GTT@home testing service also includes a software platform that enables the antenatal care team to schedule tests and view patient results.

Dr Matthew Coleman, Consultant Obstetrician, UHS
Credit: University Hospital Southampton NHS Foundation Trust

References:
1. International Diabetes Federation Diabetes Atlas 10th Edition 2021 — https://diabetesatlas.org/data/en/country/209/gb.html
2. NHS – Gestational Diabetes Overview https://www.nhs.uk/conditions/gestational-diabetes/
3. International Diabetes Federation – Gestational Diabetes – Care & Prevention 2020 https://idf.org/our-activities/care-prevention/gdm.html
4. Pub Med – Future Risk of Diabetes in Mother and Child After Gestational Diabetes Mellitus 2009 https://pubmed.ncbi.nlm.nih.gov/19150058/