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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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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...

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Published in: Wellcome Open Research
ISSN: 2398-502X
Published: F1000 Research Ltd 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa68027
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spelling 2025-02-12T15:12:08.4813016 v2 68027 2024-10-20 A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol 01491e1cd582746a654fad9addf0de16 0000-0002-7206-6530 Steve Luzio Steve Luzio true false 2024-10-20 MEDS 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. Journal Article Wellcome Open Research 9 601 F1000 Research Ltd 2398-502X Capillary, glucose, oral glucose tolerance test, method comparison, feasibility, acceptability, type 1 diabetes, monitoring, follow-up, screening 17 10 2024 2024-10-17 10.12688/wellcomeopenres.23028.1 Study Protocol COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University External research funder(s) paid the OA fee (includes OA grants disbursed by the Library) 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 2025-02-12T15:12:08.4813016 2024-10-20T13:43:32.8490749 Faculty of Science and Engineering School of Biosciences, Geography and Physics - Biosciences Rabbi Swaby 0000-0001-5815-7279 1 Claire Scudder 0000-0002-2934-4427 2 Tabitha Randell 0000-0002-1703-1589 3 M. Loredana Marcovecchio 0000-0002-4415-316x 4 Kathleen Gillespie 5 Yuk-Fun Liu 0000-0002-8518-8756 6 John A Todd 7 Gareth Dunseath 8 Steve Luzio 0000-0002-7206-6530 9 Colin Dayan 10 Rachel E J Besser 0000-0002-4645-6324 11 68027__33211__77acab07ed3e48afa4086ea87982b6a0.pdf 68027.VoR.pdf 2024-12-20T13:37:23.3247234 Output 731491 application/pdf Version of Record true © 2024 Swaby R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License. true eng https://creativecommons.org/licenses/by/4.0/
title A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
spellingShingle A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
Steve Luzio
title_short A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
title_full A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
title_fullStr A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
title_full_unstemmed A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
title_sort A study to determine a capillary alternative to the gold standard oral glucose tolerance test - Protocol
author_id_str_mv 01491e1cd582746a654fad9addf0de16
author_id_fullname_str_mv 01491e1cd582746a654fad9addf0de16_***_Steve Luzio
author Steve Luzio
author2 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
format Journal article
container_title Wellcome Open Research
container_volume 9
container_start_page 601
publishDate 2024
institution Swansea University
issn 2398-502X
doi_str_mv 10.12688/wellcomeopenres.23028.1
publisher F1000 Research Ltd
college_str Faculty of Science and Engineering
hierarchytype
hierarchy_top_id facultyofscienceandengineering
hierarchy_top_title Faculty of Science and Engineering
hierarchy_parent_id facultyofscienceandengineering
hierarchy_parent_title Faculty of Science and Engineering
department_str School of Biosciences, Geography and Physics - Biosciences{{{_:::_}}}Faculty of Science and Engineering{{{_:::_}}}School of Biosciences, Geography and Physics - Biosciences
document_store_str 1
active_str 0
description 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.
published_date 2024-10-17T05:25:15Z
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