Eer Audrey S, Hachem Mariam, Hearn Tracey, Koye Digsu N, Atkinson-Briggs Sharon, Jones Jessica, Eades Sandra, Braat Sabine, Twigg Stephen M, Sinha Ashim, McLean Anna, O'Brien Richard C, Clarke Phillip, O'Neal David, Story David, Zajac Jeffrey D, Kelly Raymond J, Burchill Luke, Ekinci Elif I
Department of Endocrinology, Austin Health, Heidelberg, Australia.
Department of Medicine, The University of Melbourne (Austin Health), Heidelberg, Australia.
Pilot Feasibility Stud. 2025 May 24;11(1):72. doi: 10.1186/s40814-025-01607-7.
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.
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).
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.
This is the first pilot RCT of FGM in Indigenous Australians with type 2 diabetes. The results support a larger RCT.
Australian New Zealand Clinical Trials Registry (ANZCTR12621000021875), retrospectively registered on 14 January 2021.
动态血糖监测（FGM）可改善糖尿病管理，但尚未在澳大利亚原住民群体中开展FGM的随机对照试验（RCT）。本研究旨在评估在患有2型糖尿病的澳大利亚原住民中开展FGM的RCT的可行性。
在这项开放标签的试点RCT中，患有2型糖尿病的成年原住民被随机分配接受FGM或标准护理6个月。符合条件的参与者正在接受注射用糖尿病药物治疗，糖化血红蛋白（HbA1c）≥7.0%。可行性结果是完成试验的参与者比例，未来试验的主要结果是HbA1c从基线到6个月的变化。次要结果包括目标血糖（4.0 - 10.0 mmol/L）时间的变化、安全性（低血糖事件）和生活质量（欧洲五维健康量表3级（EQ - 5D - 3L）评分）。
在126名筛查个体中，74名符合条件，40名（54%）被随机分组，39名（97.5%）完成了研究。除性别和体重指数外，FGM组和常规护理组参与者的基线特征相似。在以下方面未观察到组间差异：HbA1c的变化；目标血糖（4.0 - 10.0 mmol/L）、低血糖（<3.9 mmol/L）和高血糖（>15.0 mmol/L）时间的百分比；或EQ - 5D - 3L评分。未发生严重低血糖事件。
这是在患有2型糖尿病的澳大利亚原住民中进行的首次FGM试点RCT。结果支持开展更大规模的RCT。
澳大利亚新西兰临床试验注册中心（ANZCTR12621000021875），于2021年1月14日追溯注册。
