Evidence map›Paper›PMID 39030640›Full record

ArticleTrials2024

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.

Mariam Hachem, Tracey Hearn, Ray Kelly, Audrey Eer, Belinda Moore, Christine Sommerville, Sharon Atkinson-Briggs, Stephen Twigg, Meagan Freund, David O'Neal and 13 more

Erratum issuedAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Mariam HachemDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Tracey HearnDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Ray KellyDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Audrey EerDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Belinda MooreAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Christine SommervilleDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Sharon Atkinson-BriggsMedical Clinic, Rumbalara Aboriginal Cooperative, Mooroopna, Victoria, Australia.
Stephen TwiggAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Meagan FreundSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, Health Behaviour Research Collaborative, University of Newcastle, Newcastle, New South Wales, Australia.
David O'NealAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
David StoryCritical Care, FacultyofMedicine,DentistryandHealthSciences, University of Melbourne, Melbourne, Victoria, Australia.
Alex BrownIndigenous Genomics, Telethon Kids Institute, Adelaide, South Australia, Australia.
Anna McLeanDepartment of Endocrinology and Diabetes, Cairns Hospital, Cairns, Queensland, Australia.
Ashim SinhaDepartment of Endocrinology and Diabetes, Cairns Hospital, Cairns, Queensland, Australia.
John FurlerDepartment of General Practice, University of Melbourne, Melbourne, Victoria, Australia.
Richard O'BrienEndocrinology, Austin Health, Melbourne, Victoria, Australia.
An Tran-DuyAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Philip ClarkeAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Sabine BraatMethods and Implementation Support for Clinical and Health research (MISCH) Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Digsu N KoyeAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Sandra EadesCentre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Luke BurchillAustralian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Elif EkinciDepartment of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. elif.ekinci@unimelb.edu.au.ORCID http://orcid.org/0000-0003-2372-395X

Funding

National Health and Medical Research Council (AU) GNT1182464
6 · The paper itself

Abstract

backgroundAboriginal 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) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring 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 effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting.

methodsThis 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 effect 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 benefits in improving diabetes management and providing evidence for funding of CGM in this population.

trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringCost-Benefit AnalysisDiabetes Mellitus, Type 2Glycated HemoglobinAdultAustraliaAustralian Aboriginal and Torres Strait Islander PeoplesBiomarkersGlycemic ControlHumansHypoglycemiaHypoglycemic AgentsQuality of LifeRandomized Controlled Trials as TopicTime FactorsBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsAboriginal and torres Strait Islander peoplesContinuous glucose monitoringFirst NationsFlash Glucose MonitoringFreestyle Libre 2HbA1cIndigenous AustraliansRandomised controlled trialType 2 diabetes

Identifiers

PMID39030640
PMCPMC11264795

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.