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/36730530Actively Recruiting
Led by University of Oxford · Updated on 2026-04-13
135
Participants Needed
4
Research Sites
26 weeks
Total Duration
U
University of Oxford
Lead Sponsor
U
University of Bristol
Collaborating Sponsor
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
Capillary OGTT Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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)
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
R
Rabbi Swaby, BMBS
C
Claire Scudder
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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