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A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
Rabbi Swaby ,
Claire Scudder ,
Tabitha Randell ,
M. Loredana Marcovecchio ,
Kathleen Gillespie,
Yuk-Fun Liu ,
John A Todd,
Gareth Dunseath,
Steve Luzio ,
Colin Dayan,
Rachel E J Besser
Wellcome Open Research, Volume: 9, Start page: 601
Swansea University Author: Steve Luzio
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DOI (Published version): 10.12688/wellcomeopenres.23028.1
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...
Published in: | Wellcome Open Research |
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ISSN: | 2398-502X |
Published: |
F1000 Research Ltd
2024
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Online Access: |
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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. |
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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 |