Actively Recruiting

Age: 0 - 17Years
All Genders
Healthy Volunteers
ID06815081

A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test

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

135

Participants Needed

4

Research Sites

26 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 long-lasting condition affecting many children under 15, caused by the immune system damaging the pancreas, which makes insulin. Type 2 diabetes (T2D) is also chronic and related to the body's inability to use insulin properly, often linked to obesity and appearing more in adults but beginning in childhood. Early diagnosis of both T1D and T2D is important and usually involves an oral glucose tolerance test (OGTT), which can be uncomfortable and requires blood samples over 2-3 hours in a healthcare setting. This research tests if an OGTT can be done at home using a finger-prick blood test called 'GTT@home,' where blood glucose is measured before and two hours after drinking a sugary drink. The study includes groups assessing the accuracy of the finger-prick test compared to the usual vein blood test, and the acceptability and feasibility of doing the test at home for children at risk of T1D or pre-clinical T2D. A subgroup with T1D will also explore using a continuous glucose monitor (CGM) as an alternative. Participants will be involved in clinical or home settings depending on their group, undergoing OGTTs with blood glucose measurements from finger-pricks and veins, wearing CGM devices, and completing questionnaires about test acceptability. Researchers will also conduct interviews with young people, parents, and healthcare professionals to understand experiences and factors influencing monitoring uptake. The main outcomes are how well the capillary blood glucose matches venous blood glucose and how feasible the home test is, with total participation lasting up to the end of each study visit.

CONDITIONS

Brief 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
  • Under 18 years old
  • Able to drink a glucose drink within 10 minutes
  • Undergoing or consenting to have an oral glucose tolerance test (OGTT)
  • Positive for two or more islet autoantibodies (for certain groups)
  • Confirmed stage 1, 2, or 3 Type 1 Diabetes (for CGM sub-study participants)
  • Diagnosed with prediabetes as defined by raised BMI and markers of insulin resistance (for Type 2 Diabetes group)
  • Healthcare professionals involved in metabolic testing (for qualitative sub-study)
  • Young people aged 15 and above or parents involved in metabolic testing (for qualitative sub-study)
Not Eligible

You will not qualify if you...

  • Known haemoglobinopathy
  • Cystic fibrosis related diabetes
  • Non-English speaker
  • Known clinical diabetes currently on treatment (for some groups)
  • No recent weight available within 3 months and unable to obtain new measurement (for some groups)
  • Active skin issues preventing use of continuous glucose monitor (for CGM sub-study)
  • For qualitative sub-study, non-English speakers are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo oral glucose tolerance tests (OGTT) involving capillary and/or venous blood samples to assess glucose levels. Some tests are done in clinical settings while others are completed at home using a test kit with instructions.

1 to 2 visits depending on cohort assignment

Monitoring

Duration - Up to 10 days

A subgroup of participants with type 1 diabetes wear a continuous glucose monitor (CGM) sensor for up to 10 days to explore glucose monitoring as an alternative to OGTT and complete related questionnaires and food diaries.

1 in-person visit to fit CGM and home monitoring

Qualitative Assessment

Duration - 1 day

Participants, parents, and healthcare professionals take part in interviews to discuss their experiences and views on metabolic testing and the acceptability of the capillary OGTT device.

1 interview session (in-person or remote)

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

C

Claire Scudder

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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Published Research Related To This Trial

CGM Metrics Identify Dysglycemic States in Participants From the TrialNet Pathway to Prevention Study.

Darrell M Wilson, Susan L Pietropaolo, Maria Acevedo-Calado...

https://pubmed.ncbi.nlm.nih.gov/36730530

OGTT Metrics Surpass Continuous Glucose Monitoring Data for T1D Prediction in Multiple-Autoantibody-Positive Individuals.

Alyssa Ylescupidez, Cate Speake, Susan L Pietropaolo...

https://pubmed.ncbi.nlm.nih.gov/37572381

Use of self-collected capillary blood samples for islet autoantibody screening in relatives: a feasibility and acceptability study.

Y Liu, L E Rafkin, D Matheson...

https://pubmed.ncbi.nlm.nih.gov/28226181

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Erik von Elm, Douglas G Altman, Matthias Egger...

https://pubmed.ncbi.nlm.nih.gov/18313558

Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems.

Gareth J Dunseath, Dominic Bright, Stephen D Luzio

https://pubmed.ncbi.nlm.nih.gov/30623673