Actively Recruiting

Age: 0 - 17Years
All Genders
Healthy Volunteers
NCT06815081

Capillary OGTT Study

Led by University of Oxford · Updated on 2026-04-13

135

Participants Needed

4

Research Sites

182 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

U

University of Bristol

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Capillary OGTT Study

Who Can Participate

Age: 0 - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent or assent with parental consent
  • Aged under 18 years old
  • Able to consume oral glucose drink within 10 minutes
  • Undergoing an OGTT or consenting to have one (Cohort 1)
  • Positive for two or more islet autoantibodies at any time (Cohort 2)
  • Confirmed stage 1, 2, or 3 T1D and participation in Cohort 1 (CGM sub-study)
  • Young person positive for two or more islet autoantibodies (15 years or older) or parent of young person with metabolic test experience, or healthcare professional involved in metabolic testing (Qualitative sub-study)
  • Prediabetes diagnosis (Cohort 3)
Not Eligible

You will not qualify if you...

  • Known hemoglobinopathy (Cohorts 1, 2, CGM sub-study)
  • Cystic fibrosis related diabetes (Cohorts 1, CGM sub-study)
  • Non-English speaker (all cohorts and sub-studies)
  • Known clinical diabetes and on treatment (Cohorts 2, 3)
  • No recent weight measurement within 3 months of visit and unable to obtain new weight (Cohorts 2, 3)
  • Active skin issue preventing CGM use (CGM sub-study)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Noah's Ark Childrens Hospital for Wales

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

2

Royal London Barts Health NHS Trust

London, United Kingdom, E1 1FR

Actively Recruiting

3

Nottingham Childrens Hospital

Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

4

John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

R

Rabbi Swaby, BMBS

CONTACT

C

Claire Scudder

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Capillary OGTT Study | DecenTrialz