No Cover Image

Journal article 143 views 7 downloads

Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study

Gareth Dunseath Orcid Logo, Steve Luzio Orcid Logo, Ivy Cheung, Sharon Parsons Orcid Logo, Nicola John Orcid Logo, Mahmoud Chokor Orcid Logo, Michael Atkinson Orcid Logo, Rajesh Peter Orcid Logo

JMIR Diabetes, Volume: 11, Pages: e69695 - e69695

Swansea University Authors: Gareth Dunseath Orcid Logo, Steve Luzio Orcid Logo, Ivy Cheung, Sharon Parsons Orcid Logo

  • 71418.VoR.pdf

    PDF | Version of Record

    © Gareth J Dunseath, Stephen D Luzio, Wai Yee Cheung, Sharon N Parsons, Nicola John, Mahmoud Chokor, Michael Atkinson, Rajesh Peter. This is an open access article distributed under the terms of the Creative Commons Attribution License.

    Download (1.49MB)

Check full text

DOI (Published version): 10.2196/69695

Abstract

Background:The 75-g oral glucose tolerance test (OGTT) remains the optimal diagnostic test for use in pregnancy but needs to be performed in the clinical setting. The GTT@home OGTT device offers the potential to enable patients to perform the test at home using capillary blood samples.Objective:This...

Full description

Published in: JMIR Diabetes
ISSN: 2371-4379
Published: JMIR Publications Inc. 2026
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa71418
first_indexed 2026-02-13T14:26:21Z
last_indexed 2026-03-17T05:37:10Z
id cronfa71418
recordtype SURis
fullrecord <?xml version="1.0"?><rfc1807><datestamp>2026-03-16T14:37:26.6228937</datestamp><bib-version>v2</bib-version><id>71418</id><entry>2026-02-13</entry><title>Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study</title><swanseaauthors><author><sid>fccbba9edcaee08a839a3c5cff8cbe19</sid><ORCID>0000-0001-6022-862X</ORCID><firstname>Gareth</firstname><surname>Dunseath</surname><name>Gareth Dunseath</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>01491e1cd582746a654fad9addf0de16</sid><ORCID>0000-0002-7206-6530</ORCID><firstname>Steve</firstname><surname>Luzio</surname><name>Steve Luzio</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>a9142ffd398f89eff40ada503e315639</sid><firstname>Ivy</firstname><surname>Cheung</surname><name>Ivy Cheung</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>f428211d8324336eb2bc7f4e6a08a421</sid><ORCID>0000-0002-5841-8309</ORCID><firstname>Sharon</firstname><surname>Parsons</surname><name>Sharon Parsons</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2026-02-13</date><deptcode>MEDS</deptcode><abstract>Background:The 75-g oral glucose tolerance test (OGTT) remains the optimal diagnostic test for use in pregnancy but needs to be performed in the clinical setting. The GTT@home OGTT device offers the potential to enable patients to perform the test at home using capillary blood samples.Objective:This study aimed to determine the accuracy of the GTT@home device compared to the routine National Health Service laboratory reference method using blood samples during an OGTT from pregnant women at high risk of developing gestational diabetes mellitus (GDM).Methods:A total of 65 women (aged &gt;18 y), at high risk for GDM (per the National Institute for Health and Care Excellence guidelines) were recruited for this performance evaluation. Following an overnight fast, participants went for a 75-g OGTT. Fasting and 2-hour capillary glucose levels were measured using the GTT@home device with corresponding venous samples measured in the laboratory.Results:The complete data for analysis was available for 61/65 devices. The overall bias for the GTT@home device was +0.16 mmol/L. Correlation analysis of the clinical performance of the two methods using a surveillance error grid showed 79.8% of results in the lowest, 16.9% in the &#x201C;slight, lower&#x201D; and 2.4% in the &#x201C;slight, higher&#x201D; risk categories. Only 0.8% were &#x201C;moderate, lower&#x201D; risk, and none were in any higher risk categories. There was agreement in the classification in 54/61 cases. The GTT@home device under-classified 2 cases and over-classified 5 cases.Conclusions:The GTT@home device worked well in a controlled, antenatal clinical setting. Differences in classification observed were generally due to small differences in glucose values close to the diagnostic cut-offs. The GTT@home device shows promise for home testing of glucose tolerance in pregnant women.</abstract><type>Journal Article</type><journal>JMIR Diabetes</journal><volume>11</volume><journalNumber/><paginationStart>e69695</paginationStart><paginationEnd>e69695</paginationEnd><publisher>JMIR Publications Inc.</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>2371-4379</issnElectronic><keywords>device; diagnosis; gestational diabetes; OGTT; glucose; oral glucose tolerance test</keywords><publishedDay>11</publishedDay><publishedMonth>2</publishedMonth><publishedYear>2026</publishedYear><publishedDate>2026-02-11</publishedDate><doi>10.2196/69695</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Other</apcterm><funders>This clinical study was funded by Digostics Ltd.</funders><projectreference/><lastEdited>2026-03-16T14:37:26.6228937</lastEdited><Created>2026-02-13T14:21:59.2400672</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Biomedical Science</level></path><authors><author><firstname>Gareth</firstname><surname>Dunseath</surname><orcid>0000-0001-6022-862X</orcid><order>1</order></author><author><firstname>Steve</firstname><surname>Luzio</surname><orcid>0000-0002-7206-6530</orcid><order>2</order></author><author><firstname>Ivy</firstname><surname>Cheung</surname><order>3</order></author><author><firstname>Sharon</firstname><surname>Parsons</surname><orcid>0000-0002-5841-8309</orcid><order>4</order></author><author><firstname>Nicola</firstname><surname>John</surname><orcid>0009-0005-3111-5593</orcid><order>5</order></author><author><firstname>Mahmoud</firstname><surname>Chokor</surname><orcid>0000-0002-6400-6933</orcid><order>6</order></author><author><firstname>Michael</firstname><surname>Atkinson</surname><orcid>0000-0002-7767-9715</orcid><order>7</order></author><author><firstname>Rajesh</firstname><surname>Peter</surname><orcid>0009-0008-1671-627x</orcid><order>8</order></author></authors><documents><document><filename>71418__36422__08e61f8312224e549a8f79cf5697aa3f.pdf</filename><originalFilename>71418.VoR.pdf</originalFilename><uploaded>2026-03-16T14:32:30.6054466</uploaded><type>Output</type><contentLength>1558130</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; Gareth J Dunseath, Stephen D Luzio, Wai Yee Cheung, Sharon N Parsons, Nicola John, Mahmoud Chokor, Michael Atkinson, Rajesh Peter. This is an open access article distributed under the terms of the Creative Commons Attribution License.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>https://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2026-03-16T14:37:26.6228937 v2 71418 2026-02-13 Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study fccbba9edcaee08a839a3c5cff8cbe19 0000-0001-6022-862X Gareth Dunseath Gareth Dunseath true false 01491e1cd582746a654fad9addf0de16 0000-0002-7206-6530 Steve Luzio Steve Luzio true false a9142ffd398f89eff40ada503e315639 Ivy Cheung Ivy Cheung true false f428211d8324336eb2bc7f4e6a08a421 0000-0002-5841-8309 Sharon Parsons Sharon Parsons true false 2026-02-13 MEDS Background:The 75-g oral glucose tolerance test (OGTT) remains the optimal diagnostic test for use in pregnancy but needs to be performed in the clinical setting. The GTT@home OGTT device offers the potential to enable patients to perform the test at home using capillary blood samples.Objective:This study aimed to determine the accuracy of the GTT@home device compared to the routine National Health Service laboratory reference method using blood samples during an OGTT from pregnant women at high risk of developing gestational diabetes mellitus (GDM).Methods:A total of 65 women (aged >18 y), at high risk for GDM (per the National Institute for Health and Care Excellence guidelines) were recruited for this performance evaluation. Following an overnight fast, participants went for a 75-g OGTT. Fasting and 2-hour capillary glucose levels were measured using the GTT@home device with corresponding venous samples measured in the laboratory.Results:The complete data for analysis was available for 61/65 devices. The overall bias for the GTT@home device was +0.16 mmol/L. Correlation analysis of the clinical performance of the two methods using a surveillance error grid showed 79.8% of results in the lowest, 16.9% in the “slight, lower” and 2.4% in the “slight, higher” risk categories. Only 0.8% were “moderate, lower” risk, and none were in any higher risk categories. There was agreement in the classification in 54/61 cases. The GTT@home device under-classified 2 cases and over-classified 5 cases.Conclusions:The GTT@home device worked well in a controlled, antenatal clinical setting. Differences in classification observed were generally due to small differences in glucose values close to the diagnostic cut-offs. The GTT@home device shows promise for home testing of glucose tolerance in pregnant women. Journal Article JMIR Diabetes 11 e69695 e69695 JMIR Publications Inc. 2371-4379 device; diagnosis; gestational diabetes; OGTT; glucose; oral glucose tolerance test 11 2 2026 2026-02-11 10.2196/69695 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Other This clinical study was funded by Digostics Ltd. 2026-03-16T14:37:26.6228937 2026-02-13T14:21:59.2400672 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Gareth Dunseath 0000-0001-6022-862X 1 Steve Luzio 0000-0002-7206-6530 2 Ivy Cheung 3 Sharon Parsons 0000-0002-5841-8309 4 Nicola John 0009-0005-3111-5593 5 Mahmoud Chokor 0000-0002-6400-6933 6 Michael Atkinson 0000-0002-7767-9715 7 Rajesh Peter 0009-0008-1671-627x 8 71418__36422__08e61f8312224e549a8f79cf5697aa3f.pdf 71418.VoR.pdf 2026-03-16T14:32:30.6054466 Output 1558130 application/pdf Version of Record true © Gareth J Dunseath, Stephen D Luzio, Wai Yee Cheung, Sharon N Parsons, Nicola John, Mahmoud Chokor, Michael Atkinson, Rajesh Peter. 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 Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
spellingShingle Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
Gareth Dunseath
Steve Luzio
Ivy Cheung
Sharon Parsons
title_short Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
title_full Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
title_fullStr Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
title_full_unstemmed Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
title_sort Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study
author_id_str_mv fccbba9edcaee08a839a3c5cff8cbe19
01491e1cd582746a654fad9addf0de16
a9142ffd398f89eff40ada503e315639
f428211d8324336eb2bc7f4e6a08a421
author_id_fullname_str_mv fccbba9edcaee08a839a3c5cff8cbe19_***_Gareth Dunseath
01491e1cd582746a654fad9addf0de16_***_Steve Luzio
a9142ffd398f89eff40ada503e315639_***_Ivy Cheung
f428211d8324336eb2bc7f4e6a08a421_***_Sharon Parsons
author Gareth Dunseath
Steve Luzio
Ivy Cheung
Sharon Parsons
author2 Gareth Dunseath
Steve Luzio
Ivy Cheung
Sharon Parsons
Nicola John
Mahmoud Chokor
Michael Atkinson
Rajesh Peter
format Journal article
container_title JMIR Diabetes
container_volume 11
container_start_page e69695
publishDate 2026
institution Swansea University
issn 2371-4379
doi_str_mv 10.2196/69695
publisher JMIR Publications Inc.
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str 1
active_str 0
description Background:The 75-g oral glucose tolerance test (OGTT) remains the optimal diagnostic test for use in pregnancy but needs to be performed in the clinical setting. The GTT@home OGTT device offers the potential to enable patients to perform the test at home using capillary blood samples.Objective:This study aimed to determine the accuracy of the GTT@home device compared to the routine National Health Service laboratory reference method using blood samples during an OGTT from pregnant women at high risk of developing gestational diabetes mellitus (GDM).Methods:A total of 65 women (aged >18 y), at high risk for GDM (per the National Institute for Health and Care Excellence guidelines) were recruited for this performance evaluation. Following an overnight fast, participants went for a 75-g OGTT. Fasting and 2-hour capillary glucose levels were measured using the GTT@home device with corresponding venous samples measured in the laboratory.Results:The complete data for analysis was available for 61/65 devices. The overall bias for the GTT@home device was +0.16 mmol/L. Correlation analysis of the clinical performance of the two methods using a surveillance error grid showed 79.8% of results in the lowest, 16.9% in the “slight, lower” and 2.4% in the “slight, higher” risk categories. Only 0.8% were “moderate, lower” risk, and none were in any higher risk categories. There was agreement in the classification in 54/61 cases. The GTT@home device under-classified 2 cases and over-classified 5 cases.Conclusions:The GTT@home device worked well in a controlled, antenatal clinical setting. Differences in classification observed were generally due to small differences in glucose values close to the diagnostic cut-offs. The GTT@home device shows promise for home testing of glucose tolerance in pregnant women.
published_date 2026-02-11T05:34:02Z
_version_ 1860792108902776832
score 11.100225

Similar Items