Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial

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dc.contributor.authorHachem, M.
dc.contributor.authorHearn, T.
dc.contributor.authorKelly, R.
dc.contributor.authorEer, A.
dc.contributor.authorMoore, B.
dc.contributor.authorSommerville, C.
dc.contributor.authorAtkinson-Briggs, S.
dc.contributor.authorTwigg, S.
dc.contributor.authorFreund, M.
dc.contributor.authorO’Neal, D.
dc.contributor.authorStory, D.
dc.contributor.authorBrown, A.
dc.contributor.authorMcLean, A.
dc.contributor.authorSinha, A.
dc.contributor.authorFurler, J.
dc.contributor.authorO’Brien, R.
dc.contributor.authorTran Duy, A.
dc.contributor.authorClarke, P.
dc.contributor.authorBraat, S.
dc.contributor.authorKoye, D.N.
dc.contributor.authoret al.
dc.date.issued2024
dc.descriptionCorrection to : Following the publication of the original article [1], we were notified that the name of the 17th author was missing a hyphen. Originally published name: An Tran Duy Corrected name: An Tran-Duy The original article has been corrected.
dc.description.abstractBackground: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) ofers real-time glucose monitoring that is convenient and easy to use compared to self-mon‑ itoring of blood glucose (SMBG). However, this technology’s use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the efect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-efective healthcare in an Aboriginal and Torres Strait Islander people health setting. Methods: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c≥7.5% (n=350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia. Discussion: The trial will assess the efect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefts in improving diabetes management and providing evidence for funding of CGM in this population.
dc.description.statementofresponsibilityMariam Hachem, Tracey Hearn, Ray Kelly, Audrey Eer, Belinda Moore, Christine Sommerville, Sharon Atkinson, Briggs, Stephen Twigg, Meagan Freund, David O'Neal, David Story, Alex Brown, Anna McLean, Ashim Sinha, John Furler, Richard O'Brien, An Tran-Duy, Philip Clarke, Sabine Braat, Digsu N. Koye, Sandra Eades, Luke Burchill, and Elif Ekinci
dc.identifier.citationTrials, 2024; 25(1):493-1-493-16
dc.identifier.doi10.1186/s13063-024-08267-7
dc.identifier.issn1745-6215
dc.identifier.issn1745-6215
dc.identifier.orcidBrown, A. [0000-0003-2112-3918]
dc.identifier.urihttps://hdl.handle.net/2440/144086
dc.language.isoen
dc.publisherBMC
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT1182464
dc.rights© The Author(s) 2024, corrected publication 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
dc.source.urihttp://dx.doi.org/10.1186/s13063-024-08267-7
dc.subjectType 2 diabetes; Aboriginal and Torres Strait Islander peoples; Indigenous Australians; First Nations; Continuous glucose monitoring; Flash Glucose Monitoring; HbA1c; Randomised controlled trial; Freestyle Libre 2
dc.subject.meshHumans
dc.subject.meshDiabetes Mellitus, Type 2
dc.subject.meshHypoglycemia
dc.subject.meshBlood Glucose
dc.subject.meshHypoglycemic Agents
dc.subject.meshBlood Glucose Self-Monitoring
dc.subject.meshTreatment Outcome
dc.subject.meshTime Factors
dc.subject.meshQuality of Life
dc.subject.meshAdult
dc.subject.meshCost-Benefit Analysis
dc.subject.meshAustralia
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshBiomarkers
dc.subject.meshGlycemic Control
dc.subject.meshGlycated Hemoglobin
dc.subject.meshAustralian Aboriginal and Torres Strait Islander Peoples
dc.titleCan flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial
dc.typeJournal article
pubs.publication-statusPublished

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