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.
Author:
Hachem Mariam1ORCID, Hearn Tracey1, Kelly Ray1, Eer Audrey1, Moore Belinda1, Sommerville Christine1, Atkinson-Briggs Sharon1, Twigg Stephen2, Freund Meagan3, O'Neal David1, Story David1, Brown Alex4, McLean Anna5, Sinha Ashim6, Furler John1, O'Brien Richard1, Clarke Philip1, Duy-Tran An1, Braat Sabine1, Koye Digsu1, Eades Sandra1, Burchill Luke J1, Ekinci Elif Ilhan1ORCID
Affiliation:
1. University of Melbourne 2. The University of Sydney Sydney Medical School: The University of Sydney School of Medicine 3. University of Newcastle 4. Telethon Kids Institute 5. Menzies School of Health Research 6. Cairns Hospital
Abstract
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 peoples 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).
Publisher
Springer Science and Business Media LLC
Reference57 articles.
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