Audrey S Eer, Mariam Hachem, Tracey Hearn, Digsu N Koye, Sharon Atkinson-Briggs, Jessica Jones, Sandra Eades, Sabine Braat, Stephen M Twigg, Ashim Sinha, Anna McLean, Richard C O'Brien, Phillip Clarke, David O'Neal, David Story, Jeffrey D Zajac, Raymond J Kelly, Luke Burchill, Elif I Ekinci
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引用次数: 0
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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