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Capillary OGTT Study

Sponsor: University of Oxford

NCT ID: NCT06815081

View on ClinicalTrials.gov ↗

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.

Type 1 Diabetes (T1D)Type 2 Diabetes

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What we know so far

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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

person positive

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
Inclusion criteria: Cohort 1 * Willing and able to give informed consent 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 Cohort 2 * Positive for two or more islet autoantibodies at any time * Willing and able to give informed consent for participation, or assent with parental consent * Aged \< 18 years old * Able to consume oral glucose drink within 10 minutes CGM sub-study * Willing and able to give informed consent for participation, or assent with parental consent * Aged \< 18 years old * Able to consume oral glucose drink within 10 minutes * Confirmed to have stage 1, 2 or 3 T1D * Participation in Cohort 1 Qualitative sub-study * Willing and able to give informed consent for participation, or assent with parental consent Then EITHER * A young person positive for two or more islet autoantibodies (15 years old and above) at any time, or parent of a young person who has experienced a metabolic test e.g. OGTT OR * A healthcare professional involved in delivering metabolic testing Cohort 3 * Prediabetes diagnosis as above * Willing and able to give informed consent for participation, or assent with parental consent * Aged \< 18 years old * Able to consume oral glucose drink within 10 minutes Exclusion Criteria: Cohort 1 * Any known haemoglobinopathy * Cystic fibrosis related diabetes * Non-English speaker Cohort 2 * Any known haemoglobinopathy * Known clinical diabetes and on treatment * Non-English speaker * No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement CGM sub-study * Any known haemoglobinopathy * Cystic fibrosis related diabetes * Non-English speaker * Any active skin issue which would prevent the use of a CGM device Qualitative sub-study • Non-English speaker Cohort 3 * Known clinical diabetes and on treatment * Non-English speaker * No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement

Where Is This Study? (4 UK sites)

Noah's Ark Childrens Hospital for Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Ambika ShettyPrincipal Investigator

Royal London Barts Health NHS Trust

London E1 1FR, United Kingdom

Recruiting
Site contact (verified)
Ruben WillemsenPrincipal Investigator

Nottingham Childrens Hospital

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)
Rachel WilliamsPrincipal Investigator

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Rabbi Swaby, BMBSPrincipal Investigator
Rachel Besser, PhDrachel.besser@ouh.nhs.uk

How to Get in Touch

Rabbi Swaby, BMBS

Sponsor contact

CONTACT

+44 1865287578 rabbi.swaby@well.ox.ac.uk

Claire Scudder

Sponsor contact

CONTACT

+44 (0)7765 932065 capogtt@ndm.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03