Oxford, United Kingdom – Digital clinical diagnostics and diabetes home testing provider Digostics and University Hospital Southampton NHS Foundation Trust (UHS) announced today a partnership that will see expectant mothers under the care of UHS maternity services become the first, anywhere in the world, to access ground-breaking new 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.
“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.”
According to the International Diabetes Federation, up to 20%1 of UK pregnancies are impacted by GDM, with background risk factors2 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-fold4 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.
en completed, the user can immediately send their test data to their care team by scanning a snapoff fob attached to the test device with a smartphone using the GTT@home mobile app. This is enabled by the near field communication (NFC) functionality within the device, with the process akin to making a contactless mobile payment in a store. Alternatively, the patient can post the fob in the supplied prepaid envelope for processing. The GTT@home testing service also includes a software platform that enables the antenatal care team to schedule tests and view patient results.
Key aims of the collaboration include improving healthcare equity of access and reducing health inequalities by eliminating barriers associated with in-clinic testing that can be felt more acutely within specific at-risk patient cohorts. To support this, Digostics is creating multilingual home-user support.
“We also hope that testing at home proves to be appealing to the complete background social and demographic populations that we work with and we look forward to receiving feedback from those involved in the next phase of research.” further explained Matthew Coleman.
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.
“With this pilot representing a global-first, UHS’ international reputation for clinical innovation makes it the perfect partner for this project.” said Oenone Duroe, UK Market Access Director, Digostics. “We hope a successful pilot will see maternity services at other NHS trusts take their cue from UHS and explore the merits of GTT@home for diabetes home-testing."
Far too many people, in all geographies, are living with undiagnosed diabetes.
Digostics' mission is to enable healthcare providers to detect everyone with diabetes, and those at risk of developing diabetes, by eliminating the common barriers that inhibit testing and prevent the timely return of accurate diagnoses.
Digostics is proud to offer GTT@home - the most accessible and scalable way for clinical teams to realise their diabetes testing objectives.
For more information visit www.digostics.com
Digostics Limited, Harwell Innovation Centre, 173 Curie Avenue Harwell, Oxfordshire OX11 0QG
About University Hospital Southampton NHS Foundation Trust:
University Hospital Southampton NHS Foundation Trust (UHS) is one of the largest acute teaching trusts in England with a turnover of more than £1.15 billion in 2021/22. UHS provides hospital services for 1.9 million people living in southern Hampshire and specialist services – including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children’s services – to more than 3.7 million people in central southern England and the Channel Islands. Southampton General Hospital is a designated major trauma centre serving the Wessex Region and Channel Islands and is one of only two places in the south of England to offer adults and children full onsite major trauma care provision.
Every year more than 13,000 staff see 650,000 people at outpatient appointments, deal with 150,000 attendances at the emergency department and treat 160,000 admitted emergency, inpatient or day case patients. In addition, the trust delivers more than 100 outpatient clinics across the south of England to keep services local for patients. Providing these services costs £2.7 million per day.
Following the Care Quality Commission’s most recent inspection (report published in April 2019), all sites and services across UHS are now rated as ‘good’ or ‘outstanding’ in the effective and caring domains. Overall, the trust received a ‘good’ rating – and ‘outstanding’ for providing effective services. Among individual services, the CQC rated urgent and emergency services, medical care, surgery, services for children and young people and end of life care ‘good‘, with critical care ‘outstanding’. To view the full report, visit www.cqc.org.uk/provider/RHM/reports.
UHS is consistently one of the UK's highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. In partnership with the University of Southampton, UHS has £27 million of NIHR infrastructure dedicated to bringing the latest treatments to patients.
For more information, visit www.uhs.nhs.uk/ClinicalResearchinSouthampton. To help shape the future of hospital services and raise issues that are important to patients, families and visitors, become a UHS member. Anyone interested in finding out more or joining can contact the membership office on www.uhs.nhs.uk/members.
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Southampton Hospitals Charity enhances the care and treatment of our patients by raising funds to support areas that lie beyond the scope of NHS funding. For more information, visit www.southamptonhospitalscharity.org.