Effect of 6 months’ flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a ‘flash’ randomised controlled trial protocol

BMC Endocrine Disorders

Andrew R. Gray¹  Esko J. Wiltshire²  Karen E. MacKenzie³  Martin de Bock³  Barbara C. Galland⁴  Sara E. Boucher⁴  Benjamin J. Wheeler⁵  Jenny Rayns⁶  Paul A. Tomlinson⁷ 

[1] 0000 0004 1936 7830, grid.29980.3a, Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand;0000 0004 1936 7830, grid.29980.3a, Department of Paediatrics and Child Health, University of Otago Wellington, Wellington, New Zealand;0000 0001 0244 0702, grid.413379.b, Paediatric Department, Capital and Coast District Health Board, Wellington, New Zealand;0000 0004 1936 7830, grid.29980.3a, Department of Paediatrics, University of Otago, Christchurch, New Zealand;0000 0001 0040 0934, grid.410864.f, Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand;0000 0004 1936 7830, grid.29980.3a, Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand;0000 0004 1936 7830, grid.29980.3a, Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand;Paediatric Department, Southern District Health Board, Dunedin, New Zealand;Endocrinology Department, Southern District Health Board, Dunedin, New Zealand;Paediatric Department, Southern District Health Board, Invercargill, New Zealand;

关键词: Adolescents;    Flash glucose monitoring;    FreeStyle libre;    Glucose monitoring;    Glycaemic control;    Intermittent continuous glucose monitoring;    Self-monitoring of blood glucose;    Type 1 diabetes;    Young adults;   

DOI  :  10.1186/s12902-019-0378-z

来源: publisher

【 摘 要 】

BackgroundTeenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D.MethodsThis is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13–20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability.Discussion>If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group.Trial registrationThis trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 (ACTRN12618000320257p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).

【 授权许可】

CC BY