GTT@home Test Kit
Research type
Research Study
Full title
Study of the Accuracy of the GTT@home Oral Glucose Tolerance Test Kit
IRAS ID
312243
Contact name
Rajesh Peter
Contact email
Sponsor organisation
Digostics Limited
ISRCTN Number
ISRCTN66273796
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
The GTT@home oral glucose tolerance test device is an electronic device that has the potential to enable patients to perform an oral glucose tolerance test (OGTT) from home.
Gestational diabetes mellitus (GDM) is a common metabolic disorder occurring in up to 10% of pregnancies in the western world. Most women with GDM are asymptomatic and therefore it is important to screen, diagnose and manage the condition as it is associated with an increased risk of maternal and perinatal complications. In the UK, women with a high risk of GDM are offered a 75g glucose tolerance test (OGTT) at 24-28 weeks gestation. Undertaking an OGTT without bringing pregnant mothers into the clinical setting or keeping them in clinic for extended periods would be an attractive option, especially if the test could be performed in the comfort of the home.
In non-pregnant women the GTT@home device has been previously shown to be easy to use, reliable and demonstrate excellent agreement with the results obtained from laboratory analysers. As part of the development programme it is now necessary to establish how results from this device compare with results obtained conventionally from an oral glucose tolerance test in women at risk of GDM. In this study glucose concentrations during an oral glucose tolerance test will be tested with fresh blood samples from women at risk of gestational diabetes in the UK and compared to routine laboratory glucose concentrations.
REC name
Wales REC 6
REC reference
22/WA/0153
Date of REC Opinion
17 Jun 2022
REC opinion
Favourable Opinion