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
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.
