Study of the accuracy of a home oral glucose tolerance test kit
| ISRCTN | ISRCTN66273796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66273796 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 312243 |
| Protocol serial number | 1.0, IRAS 312243 |
| Sponsor | Digostics Ltd |
| Funder | Digostics Ltd |
- Submission date
- 07/03/2023
- Registration date
- 16/05/2023
- Last edited
- 24/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
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 75 g 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.
Who can participate?
Women aged 18 years and over with a body mass index (BMI) above 20 kg/m², a previous macrosomic (larger than average) baby, previous gestational diabetes, a family history of diabetes or of an ethnicity with a high prevalence of diabetes
What does the study involve?
Glucose concentrations during an oral glucose tolerance test will be tested with fresh blood samples from women at risk of GDM and compared to routine laboratory glucose concentrations.
What are the possible benefits and risks of participating?
There will be no benefits to participants, however, there may be benefits in the future to patients who require an oral glucose tolerance test. There may be some pain during blood sampling with possible bruising, swelling or irritation.
Where is the study run from?
Neath Port Talbot Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2022 to October 2023
Who is funding the study?
Digostics Ltd (UK)
Who is the main contact?
Prof. S Luzio, s.luzio@swansea.ac.uk
Contact information
Scientific
Diabetes Research Group
Grove Building
Medical School
Swansea University
Singleton Park
Swansea
SA28PP
United Kingdom
 ORCID ID |
0000-0002-7206-6530 |
|---|---|
| Phone | +44 (0)1792295078 |
| s.luzio@swansea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Study of the accuracy of the GTT@home oral glucose tolerance test kit |
| Study objectives | To compare the accuracy of the GTT@home device to a laboratory reference method |
| Ethics approval(s) | Approved 14/07/2022, Wales Research Ethics Committee 6 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; UK; +44 (0)2922 940910, +44 (0)2922 940954, +44 (0)2922 941090; Wales.REC6@wales.nhs.uk), ref: 22/WA/0153 |
| Health condition(s) or problem(s) studied | Gestational diabetes |
| Intervention | A total of 65 women who meet the inclusion/exclusion criteria will have a glucose tolerance test. Fingerprick blood capillary blood samples will be measured using the GTT@home device. Venous blood samples will be measured using a routine laboratory analyser. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | GTT@home |
| Primary outcome measure(s) |
Accuracy measured by comparison of the categories of normal glucose tolerance and glucose intolerance using venous and capillary blood glucose readings at fasting and 2 hours |
| Key secondary outcome measure(s) |
1. Sensitivity measured by comparison of the categories of normal glucose tolerance and glucose intolerance using venous and capillary blood glucose readings at fasting and 2 hours |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 65 |
| Key inclusion criteria | 1. Female 2. Age greater than or equal to 18 years 3. BMI above 20 kg/m² 4. Previous macrosomic baby weighing greater than or equal to 4.5 kg or the 90th centile 5. Previous gestational diabetes 6. Family history of diabetes (first-degree relative with diabetes) 7. An ethnicity with a high prevalence of diabetes 8. Written, signed, informed consent |
| Key exclusion criteria | 1. Unable or unwilling to sign informed consent |
| Date of first enrolment | 08/03/2023 |
| Date of final enrolment | 31/10/2023 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Port Talbot
SA12 7BX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Prof. S Luzio (s.luzio@swansea.ac.uk) The type of data that will be shared: Demographic data and blood glucose concentrations Dates of availability: Following publication of results paper (approx. April 2024) Whether consent from participants was required and obtained: Written informed consent was obtained from participants Comments on data anonymization: All data will be anonymised and data will only be identified using a participant study number |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/03/2023: Trial's existence confirmed by the HRA.
