Background and objective:
In non-Indigenous populations with diabetes, knowledge gained from continuously monitoring of blood glucose levels has led to behavioural change and a reduction in blood glucose levels. However, this has never been studied in Indigenous Australians. We therefore conducted a pilot and feasibility study aimed to assess the feasibility of performing a larger multicentre trial using flash glucose monitoring (FGM) compared to standard care in Indigenous Australians with type 2 diabetes on injectable therapies.

Methods:
In this non-masked, individually randomised controlled pilot and feasibility study, Indigenous people with type 2 diabetes were randomised to FGM or standard care for 6 months. Eligible participants were Indigenous Australians aged ≥18 years with type 2 diabetes, have high blood glucose (defined as HbA1c of ≥ 7.0%) and on diabetes treatment that included injectable therapies. Primary effectiveness outcome was change in HbA1c from baseline to 6 months.

Results:
We randomly assigned 40 participants, with 20 allocated to the intervention device (FGM) and 20 to the control arm, and 39 completed the study. Participants’ baseline characteristics were similar between groups except for sex and body mass index. The primary outcome, mean difference in HbA1c at 6 months was 0.19% (95% confidence interval -1.20 to 0.81). No participants experienced a severe hypoglycaemic event during the study period.

Conclusions:
This is the first randomised controlled pilot and feasibility study comparing FGM to standard care in Indigenous Australians with type 2 diabetes. The high recruitment and retention rates show promise for a larger multicentre randomised controlled trial which is currently in progress. REGISTRATION Registered at the Australian and New Zealand Clinical Trials Registry (ACTRN12621000021875).