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A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol

Rabbi Swaby Orcid Logo, Claire Scudder Orcid Logo, Tabitha Randell Orcid Logo, M. Loredana Marcovecchio Orcid Logo, Kathleen Gillespie, Yuk-Fun Liu Orcid Logo, John A Todd, Gareth Dunseath, Steve Luzio Orcid Logo, Colin Dayan, Rachel E J Besser Orcid Logo

Wellcome Open Research, Volume: 9, Start page: 601

Swansea University Author: Steve Luzio Orcid Logo

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Abstract

Type 1 diabetes (T1D) is a chronic condition caused by the immune destruction of the pancreatic beta cells. T1D has recognised asymptomatic pre-clinical stages, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. The oral glucose tolerance tes...

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Published in: Wellcome Open Research
ISSN: 2398-502X
Published: F1000 Research Ltd 2024
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa68027
Abstract: Type 1 diabetes (T1D) is a chronic condition caused by the immune destruction of the pancreatic beta cells. T1D has recognised asymptomatic pre-clinical stages, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. The oral glucose tolerance test (OGTT) is the gold standard method to stage and monitor early-stage T1D, which can be poorly tolerated and may contribute to marked loss to follow-up.Our study aims to test the accuracy, feasibility, and acceptability of a capillary alternative (‘GTT@home’ test kit) to the gold standard OGTT.We will invite 45 children and young people (CYP) across the spectrum of glycaemia with or without diabetes, from established research platforms or clinical care, to have a standard 2-hour OGTT, with capillary samples collected alongside their venous samples, at 0 and 120 minutes. A subgroup (n=20) will also have 60-minute capillary and venous samples collected.We will also invite 45 CYP from established research platforms, who are known to have two or more islet autoantibodies and are not on insulin, to undergo a capillary OGTT at home, using the GTT@home kit.We will assess the agreement of capillary and venous glucose and measure diagnostic accuracy by calculating the sensitivity and specificity of capillary measures at established diagnostic thresholds (fasting [5.6 mmol/L, 7.0 mmol/L], 60 minutes post glucose load [11.1 mmol/L] and 120 minutes post glucose load [7.8 mmol/L and 11.1 mmol/L]), using venous glucose as the gold standard.These studies will inform our understanding of whether the GTT@home device can be used in CYP in routine clinical care.
Item Description: Study Protocol
Keywords: Capillary, glucose, oral glucose tolerance test, method comparison, feasibility, acceptability, type 1 diabetes, monitoring, follow-up, screening
College: Faculty of Science and Engineering
Funders: This work was supported by Wellcome (107212/A/15/Z), Novo Nordisk UK Research Foundation. This study is sponsored by the University of Oxford, and the funder had no role in the design of this protocol
Start Page: 601