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Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial

Othmar Moser, Max Eckstein, Olivia McCarthy, Rachel Deere, Jason Pitt, David M. Williams, Jennifer Hayes, Harald Sourij Orcid Logo, Steve Bain Orcid Logo, Richard Bracken Orcid Logo

Diabetes, Obesity and Metabolism, Volume: 21, Issue: 11, Pages: 2505 - 2512

Swansea University Authors: Othmar Moser, Max Eckstein, Olivia McCarthy, Rachel Deere, Jason Pitt, Steve Bain Orcid Logo, Richard Bracken Orcid Logo

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DOI (Published version): 10.1111/dom.13835

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AimsThe efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the pe...

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Published in: Diabetes, Obesity and Metabolism
ISSN: 1462-8902 1463-1326
Published: Wiley 2019
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This study aimed to determine the performance of the flash GM system during daily&#x2010;life glycaemic challenges such as carbohydrate&#x2010;rich meals, bolus insulin&#x2010;induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes.Materials and methodsThis study comprised four randomized trial visits with alternating pre&#x2010; and post&#x2010;exercise bolus insulin doses. Throughout the four 14&#x2010;hour inpatient phases, 19 participants received three carbohydrate&#x2010;rich meals and performed moderate&#x2010;intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland&#x2013;Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II&#x2013;510(K)).ResultsThe overall MARD (IQR) during inpatient phases was 14.3% (6.9%&#x2013;22.8%), during hypoglycaemia (&#x2264;3.9 mmol/L) was 31.6% (16.2%&#x2013;46.8%), during euglycaemia (4.0 mmol/L&#x2009;&#x2212; 9.9 mmol/L) was 16.0% (8.5%&#x2013;24.0%) and during hyperglycaemia (&#x2265;10 mmol/L) was 9.4% (5.1%&#x2013;15.7%). Overall Bland&#x2013;Altman analysis showed a bias (95% LoA) of 1.26&#x2009;mmol/L (&#x2212;1.67 to 4.19&#x2009;mmol/L). The overall MARD during acute exercise was 29.8% (17.5%&#x2013;39.8%), during hypoglycaemia was 45.1% (35.2%&#x2013;51.1%), during euglycaemia was 30.7% (18.7%&#x2013;39.2%) and during hyperglycaemia was 16.3% (10.0%&#x2013;22.8%).ConclusionFlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.</abstract><type>Journal Article</type><journal>Diabetes, Obesity and Metabolism</journal><volume>21</volume><journalNumber>11</journalNumber><paginationStart>2505</paginationStart><paginationEnd>2512</paginationEnd><publisher>Wiley</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1462-8902</issnPrint><issnElectronic>1463-1326</issnElectronic><keywords/><publishedDay>1</publishedDay><publishedMonth>11</publishedMonth><publishedYear>2019</publishedYear><publishedDate>2019-11-01</publishedDate><doi>10.1111/dom.13835</doi><url/><notes/><college>COLLEGE NANME</college><department>Sport and Exercise Sciences</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>STSC</DepartmentCode><institution>Swansea University</institution><apcterm/><funders/><projectreference/><lastEdited>2022-12-02T19:00:11.2383009</lastEdited><Created>2019-08-19T10:23:28.9268340</Created><path><level id="1">Faculty of Science and Engineering</level><level id="2">School of Aerospace, Civil, Electrical, General and Mechanical Engineering - Sport and Exercise Sciences</level></path><authors><author><firstname>Othmar</firstname><surname>Moser</surname><order>1</order></author><author><firstname>Max</firstname><surname>Eckstein</surname><order>2</order></author><author><firstname>Olivia</firstname><surname>McCarthy</surname><order>3</order></author><author><firstname>Rachel</firstname><surname>Deere</surname><order>4</order></author><author><firstname>Jason</firstname><surname>Pitt</surname><order>5</order></author><author><firstname>David M.</firstname><surname>Williams</surname><order>6</order></author><author><firstname>Jennifer</firstname><surname>Hayes</surname><order>7</order></author><author><firstname>Harald</firstname><surname>Sourij</surname><orcid>0000-0003-3510-9594</orcid><order>8</order></author><author><firstname>Steve</firstname><surname>Bain</surname><orcid>0000-0001-8519-4964</orcid><order>9</order></author><author><firstname>Richard</firstname><surname>Bracken</surname><orcid>0000-0002-6986-6449</orcid><order>10</order></author></authors><documents><document><filename>51468__15045__7d95c17fc8ea4ce8a95cbd9d3817c5b5.pdf</filename><originalFilename>moser2019(5).pdf</originalFilename><uploaded>2019-08-19T10:25:40.1100000</uploaded><type>Output</type><contentLength>1068966</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2019-08-19T00:00:00.0000000</embargoDate><documentNotes>Distributed under the terms of a Creative Commons Attribution (CC-BY-4.0)</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2022-12-02T19:00:11.2383009 v2 51468 2019-08-19 Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial 3b249efea402d5413effa1e67f31bdfa Othmar Moser Othmar Moser true false 88e3800018f862425765f3e36da8de30 Max Eckstein Max Eckstein true false 4fea3e19b39712dea1d051d317614572 Olivia McCarthy Olivia McCarthy true false 3fd2ee8d0217f8487c472f52ba7c6b0a Rachel Deere Rachel Deere true false 0103027605e3ccd2909f4170d9d2c96f Jason Pitt Jason Pitt true false 5399f4c6e6a70f3608a084ddb938511a 0000-0001-8519-4964 Steve Bain Steve Bain true false f5da81cd18adfdedb2ccb845bddc12f7 0000-0002-6986-6449 Richard Bracken Richard Bracken true false 2019-08-19 STSC AimsThe efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the performance of the flash GM system during daily‐life glycaemic challenges such as carbohydrate‐rich meals, bolus insulin‐induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes.Materials and methodsThis study comprised four randomized trial visits with alternating pre‐ and post‐exercise bolus insulin doses. Throughout the four 14‐hour inpatient phases, 19 participants received three carbohydrate‐rich meals and performed moderate‐intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland–Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II–510(K)).ResultsThe overall MARD (IQR) during inpatient phases was 14.3% (6.9%–22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%–46.8%), during euglycaemia (4.0 mmol/L − 9.9 mmol/L) was 16.0% (8.5%–24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%–15.7%). Overall Bland–Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (−1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%–39.8%), during hypoglycaemia was 45.1% (35.2%–51.1%), during euglycaemia was 30.7% (18.7%–39.2%) and during hyperglycaemia was 16.3% (10.0%–22.8%).ConclusionFlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements. Journal Article Diabetes, Obesity and Metabolism 21 11 2505 2512 Wiley 1462-8902 1463-1326 1 11 2019 2019-11-01 10.1111/dom.13835 COLLEGE NANME Sport and Exercise Sciences COLLEGE CODE STSC Swansea University 2022-12-02T19:00:11.2383009 2019-08-19T10:23:28.9268340 Faculty of Science and Engineering School of Aerospace, Civil, Electrical, General and Mechanical Engineering - Sport and Exercise Sciences Othmar Moser 1 Max Eckstein 2 Olivia McCarthy 3 Rachel Deere 4 Jason Pitt 5 David M. Williams 6 Jennifer Hayes 7 Harald Sourij 0000-0003-3510-9594 8 Steve Bain 0000-0001-8519-4964 9 Richard Bracken 0000-0002-6986-6449 10 51468__15045__7d95c17fc8ea4ce8a95cbd9d3817c5b5.pdf moser2019(5).pdf 2019-08-19T10:25:40.1100000 Output 1068966 application/pdf Version of Record true 2019-08-19T00:00:00.0000000 Distributed under the terms of a Creative Commons Attribution (CC-BY-4.0) true eng
title Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
spellingShingle Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
Othmar Moser
Max Eckstein
Olivia McCarthy
Rachel Deere
Jason Pitt
Steve Bain
Richard Bracken
title_short Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
title_full Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
title_fullStr Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
title_full_unstemmed Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
title_sort Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial
author_id_str_mv 3b249efea402d5413effa1e67f31bdfa
88e3800018f862425765f3e36da8de30
4fea3e19b39712dea1d051d317614572
3fd2ee8d0217f8487c472f52ba7c6b0a
0103027605e3ccd2909f4170d9d2c96f
5399f4c6e6a70f3608a084ddb938511a
f5da81cd18adfdedb2ccb845bddc12f7
author_id_fullname_str_mv 3b249efea402d5413effa1e67f31bdfa_***_Othmar Moser
88e3800018f862425765f3e36da8de30_***_Max Eckstein
4fea3e19b39712dea1d051d317614572_***_Olivia McCarthy
3fd2ee8d0217f8487c472f52ba7c6b0a_***_Rachel Deere
0103027605e3ccd2909f4170d9d2c96f_***_Jason Pitt
5399f4c6e6a70f3608a084ddb938511a_***_Steve Bain
f5da81cd18adfdedb2ccb845bddc12f7_***_Richard Bracken
author Othmar Moser
Max Eckstein
Olivia McCarthy
Rachel Deere
Jason Pitt
Steve Bain
Richard Bracken
author2 Othmar Moser
Max Eckstein
Olivia McCarthy
Rachel Deere
Jason Pitt
David M. Williams
Jennifer Hayes
Harald Sourij
Steve Bain
Richard Bracken
format Journal article
container_title Diabetes, Obesity and Metabolism
container_volume 21
container_issue 11
container_start_page 2505
publishDate 2019
institution Swansea University
issn 1462-8902
1463-1326
doi_str_mv 10.1111/dom.13835
publisher Wiley
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 Aerospace, Civil, Electrical, General and Mechanical Engineering - Sport and Exercise Sciences{{{_:::_}}}Faculty of Science and Engineering{{{_:::_}}}School of Aerospace, Civil, Electrical, General and Mechanical Engineering - Sport and Exercise Sciences
document_store_str 1
active_str 0
description AimsThe efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the performance of the flash GM system during daily‐life glycaemic challenges such as carbohydrate‐rich meals, bolus insulin‐induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes.Materials and methodsThis study comprised four randomized trial visits with alternating pre‐ and post‐exercise bolus insulin doses. Throughout the four 14‐hour inpatient phases, 19 participants received three carbohydrate‐rich meals and performed moderate‐intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland–Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II–510(K)).ResultsThe overall MARD (IQR) during inpatient phases was 14.3% (6.9%–22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%–46.8%), during euglycaemia (4.0 mmol/L − 9.9 mmol/L) was 16.0% (8.5%–24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%–15.7%). Overall Bland–Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (−1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%–39.8%), during hypoglycaemia was 45.1% (35.2%–51.1%), during euglycaemia was 30.7% (18.7%–39.2%) and during hyperglycaemia was 16.3% (10.0%–22.8%).ConclusionFlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.
published_date 2019-11-01T04:03:22Z
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score 11.036706

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