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

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

Trials. 2024 Jul 19;25(1):493. doi: 10.1186/s13063-024-08267-7.

Authors

Mariam Hachem^{1

2

3}, Tracey Hearn^{1

3

4}, Ray Kelly^{1

3}, Audrey Eer^{1

2}, Belinda Moore^{3

5}, Christine Sommerville^{1

3}, Sharon Atkinson-Briggs⁴, Stephen Twigg³, Meagan Freund⁶, David O'Neal^{3

7

8}, David Story⁹, Alex Brown^{10

11}, Anna McLean¹², Ashim Sinha¹², John Furler¹³, Richard O'Brien², An Tran-Duy^{3

14

15}, Philip Clarke^{3

14

16}, Sabine Braat^{15

17}, Digsu N Koye^{3

15

17}, Sandra Eades¹⁴, Luke Burchill^{3

18}, Elif Ekinci^{19

20

21}

Affiliations

¹ Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
² Endocrinology, Austin Health, Melbourne, Victoria, Australia.
³ Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
⁴ Medical Clinic, Rumbalara Aboriginal Cooperative, Mooroopna, Victoria, Australia.
⁵ Implementation Science Research Group, University of Melbourne, Melbourne, Victoria, Australia.
⁶ School of Medicine and Public Health, College of Health, Medicine and Wellbeing, Health Behaviour Research Collaborative, University of Newcastle, Newcastle, New South Wales, Australia.
⁷ Department of Medicine, FacultyofMedicine,DentistryandHealth Sciences, University of Melbourne, Melbourne, Victoria, Australia.
⁸ Endocrinology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
⁹ Critical Care, FacultyofMedicine,DentistryandHealthSciences, University of Melbourne, Melbourne, Victoria, Australia.
¹⁰ Indigenous Genomics, Telethon Kids Institute, Adelaide, South Australia, Australia.
¹¹ Indigenous Genomics, The Australian National University, Canberra, Australian Capital Territory, Australia.
¹² Department of Endocrinology and Diabetes, Cairns Hospital, Cairns, Queensland, Australia.
¹³ Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia.
¹⁴ Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
¹⁵ Methods and Implementation Support for Clinical and Health research (MISCH) Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
¹⁶ Health Economics Research Centre, University of Oxford, Oxford, United Kingdom.
¹⁷ Centre for Epidemiology and BiostatisticsMelbourne School of Population and Global HealthFaculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
¹⁸ Cardiovascular Medicine, Rochester, Minnesota, United States of America.
¹⁹ Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. [email protected].
²⁰ Endocrinology, Austin Health, Melbourne, Victoria, Australia. [email protected].
²¹ Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. [email protected].

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.

Keywords: Aboriginal and torres Strait Islander peoples; Continuous glucose monitoring; First Nations; Flash Glucose Monitoring; Freestyle Libre 2; HbA1c; Indigenous Australians; Randomised controlled trial; Type 2 diabetes.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Australia
Australian Aboriginal and Torres Strait Islander Peoples
Biomarkers / blood
Blood Glucose Self-Monitoring*
Blood Glucose* / metabolism
Cost-Benefit Analysis*
Diabetes Mellitus, Type 2* / blood
Diabetes Mellitus, Type 2* / diagnosis
Diabetes Mellitus, Type 2* / ethnology
Diabetes Mellitus, Type 2* / therapy
Glycated Hemoglobin* / analysis
Glycated Hemoglobin* / metabolism
Glycemic Control
Humans
Hypoglycemia / blood
Hypoglycemia / prevention & control
Hypoglycemic Agents / therapeutic use
Quality of Life
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome

Substances

Biomarkers
Blood Glucose
Glycated Hemoglobin
hemoglobin A1c protein, human
Hypoglycemic Agents

Grants and funding

GNT1182464/National Health and Medical Research Council (AU)