At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- Up to 17 Years
- Who
- All
- Number of participants
- 135
- Started
- 2024-02-29
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for type 1 diabetes (t1d)
- • Clinical study - 135 participants
- • Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years
Who can take part?
- • Ages Up to 17 Years
- • Diagnosed with type 1 diabetes (t1d)
Where?
- • Cardiff - Noah's Ark Childrens Hospital for Wales
- • London - Royal London Barts Health NHS Trust
- • Nottingham - Nottingham Childrens Hospital
- • Oxford - John Radcliffe Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. Type 2 diabetes (T2D) is also a chronic condition where the body cannot make enough insulin, or cannot respond to the insulin properly. It is usually related to obesity, rather than an immune problem. It is more common in adults, but the early stages often start in childhood (up to 1 in 4 children in some clinics). Like T1D, early detection can delay onset of T2D, or even prevent it altogether. Early diagnosis of T1D or T2D often relies on a test called the oral glucose tolerance test (OGTT), which is commonly used but not well tolerated, possibly because it requires a drip inserted into the vein, and several blood samples taken over 2-3 hours in a healthcare setting. Our study aims to test whether we can do an OGTT using a finger-prick to test glucose, at home. We call this the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. We will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. We plan to recruit 90 children and young people, across two groups to assess the GTT@home. To understand the experiences of those involved in monitoring, we will invite young people, parents and healthcare workers to take part in an interview, to understand the impact of testing to predict clinical T1D. Group 1 will assess the accuracy of measuring glucose from a finger-prick blood test when compared to a blood test from the vein. We will recruit individuals who are having an OGTT as part of a research study, for clinical care or if they have agreed to have an OGTT for this study. Those with T1D will be invited to wear a CGM to explore its use as an additional, practical alternative. Groups 2 and 3 will assess how well the GTT@home test works when done at home and how acceptable it is. This will only be offered to those known to be at risk of T1D. These studies will help us to understand if the GTT@home can be used in routine care.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 17 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Cohort 1
- ✓Willing and able to give agreement to take part for participation, or assent with parental consent
- ✓Aged \< 18 years old
- ✓Able to consume oral glucose drink within 10 minutes
- ✓Undergoing an OGTT, or consent to have one
Who cannot take part
- ✗Cohort 1
- ✗Any known haemoglobinopathy
- ✗Cystic fibrosis related diabetes
- ✗Non-English speaker
- ✗Cohort 2
See the full criteria
Where Is This Study? (4 UK sites)
Noah's Ark Childrens Hospital for Wales
Cardiff CF14 4XW, United Kingdom
Royal London Barts Health NHS Trust
London E1 1FR, United Kingdom
Nottingham Childrens Hospital
Nottingham NG7 2UH, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Rabbi Swaby, BMBS
Sponsor contactCONTACT
Claire Scudder
Sponsor contactCONTACT
