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; 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; Elif Ekinci

doi:10.1186/s13063-024-08267-7

Trials (Jul 2024)

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,
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,
Elif Ekinci

Affiliations

Mariam Hachem: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Tracey Hearn: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Ray Kelly: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Audrey Eer: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Belinda Moore: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Christine Sommerville: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Sharon Atkinson-Briggs: Medical Clinic, Rumbalara Aboriginal Cooperative
Stephen Twigg: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Meagan Freund: School of Medicine and Public Health, College of Health, Medicine and Wellbeing, Health Behaviour Research Collaborative, University of Newcastle
David O’Neal: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
David Story: Critical Care, FacultyofMedicine,DentistryandHealthSciences, University of Melbourne
Alex Brown: Indigenous Genomics, Telethon Kids Institute
Anna McLean: Department of Endocrinology and Diabetes, Cairns Hospital
Ashim Sinha: Department of Endocrinology and Diabetes, Cairns Hospital
John Furler: Department of General Practice, University of Melbourne
Richard O’Brien: Endocrinology, Austin Health
An Tran Duy: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Philip Clarke: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Sabine Braat: Methods and Implementation Support for Clinical and Health research (MISCH) Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Digsu N. Koye: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Sandra Eades: Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne
Luke Burchill: Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
Elif Ekinci: Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne

DOI: https://doi.org/10.1186/s13063-024-08267-7
Journal volume & issue: Vol. 25, no. 1
pp. 1 – 16

Abstract

Read online

Abstract Background 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) 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. 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 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 registration Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.

Published in Trials

ISSN: 1745-6215 (Online)
Publisher: BMC
Country of publisher: United Kingdom
LCC subjects: Medicine: Medicine (General)
Website: https://trialsjournal.biomedcentral.com

About the journal

Abstract

Keywords