Study of the Accuracy of the SmartSensor telemed OGTT Device
Research type
Research Study
Full title
Study of the Accuracy of the SmartSensor telemed (SSt) Oral Glucose Tolerance Test Device
IRAS ID
223995
Contact name
Sarah Dowrick
Contact email
Sponsor organisation
Owen Mumford
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
The SmartSensor (SSt) oral glucose tolerance test device is an electronic device that would have the potential to enable patients to perform an oral glucose tolerance test (OGTT) from home. It is intended to be used for screening the general population for prediabetes and type 2 diabetes, but also has the potential to be used in pregnant women to diagnose gestational diabetes.
Gestational diabetes mellitus (GDM) is a common metabolic disorder occurring in up to 10% of pregnancies in the western world (1). 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 such as pre-eclampsia, macrosomia, shoulder dystocia and neonatal hypoglycaemia. In the UK, women with a high risk of GDM (e.g. obese, previous macrosomic baby, previous gestational diabetes, family history of type 2 diabetes mellitus) are offered a 75g glucose tolerance test (OGTT) at 24-28 weeks gestation (2) with plasma glucose ≥ 5.6 mmol/l or 2-hour plasma glucose ≥ 7.8 mmol/l diagnostic of gestational diabetes.
As part of the development programme it is necessary to establish how results from this device compare with results obtained conventionally from an oral glucose tolerance test. In this study glucose concentrations during an oral glucose tolerance test will be tested with fresh blood samples from a population which would be similar to that at risk of gestational diabetes in the UK (except participants do not need necessarily to be pregnant) and compared to reference laboratory glucose concentrations across a wide range of glucose concentrations.
REC name
Wales REC 6
REC reference
17/WA/0079
Date of REC Opinion
20 Mar 2017
REC opinion
Favourable Opinion