Flash glucose monitoring for Indigenous Australians with type 2 diabetes: a randomised pilot and feasibility study

Abstract

BACKGROUND: Flash glucose monitoring (FGM) can improve diabetes management, but no randomised controlled trials (RCTs) of FGM have been undertaken in Indigenous Australian populations. This study aimed to assess the feasibility of performing a RCT of FGM in Indigenous Australians with type 2 diabetes. METHODS: In this open-labelled pilot RCT, Indigenous adults with type 2 diabetes were randomised to FGM or standard care for 6 months. Eligible participants were being treated with injectable diabetes medications and had a glycosylated haemoglobin (HbA1c) ≥ 7.0%. The feasibility outcome was the proportion of participants completing the trial, and the primary outcome for the future trial was change in HbA1c from baseline to 6 months. Secondary outcomes included change in time spent in target blood glucose (4.0-10.0 mmol/L), safety (hypoglycaemic episodes), and quality of life (EuroQol 5-dimension 3-level (EQ-5D-3L) score). RESULTS: Of 126 screened individuals, 74 were eligible, 40 (54%) were randomised, and 39 (97.5%) completed the study. Participants' baseline characteristics were similar between the FGM and usual care groups, except for sex and body mass index. No between-group differences were observed for the following: change in HbA1c; percentage of time spent in target blood glucose (4.0-10.0 mmol/L), low glucose (< 3.9 mmol/L), and high glucose (> 15.0 mmol/L); or EQ-5D-3L scores. No severe hypoglycaemic episodes occurred. CONCLUSIONS: This is the first pilot RCT of FGM in Indigenous Australians with type 2 diabetes. The results support a larger RCT. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR12621000021875), retrospectively registered on 14 January 2021.