Adolescence is a time when healthy glycaemic control is the hardest to achieve for those living with type 1 diabetes mellitus (T1DM). Self-monitoring is essential for maintaining safe glucose levels and preventing long-term diabetes complications, but adequate glucose monitoring during this life stage is difficult. Conventional glucose monitoring involves painful fingerstick blood tests six or more times each day. Young people infrequently monitor glucose levels because of social pressure to not be seen as "different," and physical discomfort from pricking their fingers. Adolescents need new effective tools to manage their chronic condition. Novel flash continuous glucose monitoring (FGM) technology has been effective for diabetes management among adherent adults with healthy glycaemic control. We hypothesise that "flash" technology may reduce diabetes burden by facilitating glucose monitoring, which may in turn result in improved glycaemic control among adolescents, especially those with unhealthy glycaemic control. Research is needed to investigate the impact of FGM on glucose monitoring behaviour and glycaemic control among adolescents with poorly controlled diabetes, as they experience the greatest burden of diabetes and may benefit the most if the technology is effective.
The overall study aim is to investigate the use of flash continuous glucose monitoring (FGM) in a real-world setting among adolescents with type 1 diabetes mellitus (T1D) and a history of suboptimal glycaemic control. The primary objective is to investigate the impact of FGM on glycaemic control as measured by HbA1c. The secondary objectives are to investigate the frequency of sensor scanning (i.e. the feasibility of using FGM to self-monitor glucose levels), acceptability and safety of FGM (i.e. diabetic ketoacidosis, severe hypoglycaemia), and changes in treatment satisfaction and psychosocial variables.
This research is divided into two phases. The first phase of this research is a 6-month randomised controlled trial (RCT) investigating FGM in addition to usual care vs usual care only (control). The RCT is designed to explore the effectiveness and safety of FGM among adolescent patients with type 1 diabetes with a history of suboptimal glycaemic control (mean HbA1c >80mmol/mol in past 6 months). Participants will be randomised in equal numbers to either six months of FGM supplies or a waitlist control group.
During the second phase of this research, the intervention group will continue FGM for an additional six months to explore all outcomes at 12 months. During the same extended trial period, the waitlist control group will cross over and commence FGM for six months. The purpose of offering FGM to the waitlist group is to encourage retention and engagement. Neither group will undergo a washout period. The longitudinal study of the intervention group will enable an investigation of FGM on 12-month outcomes. The 6-month follow-on study of FGM among the waitlist control group will provide further evidence of the impact of FGM over a 6-month time period.
64 participants will be recruited for the study and equal numbers of participants will be allocated to either FGM group or the waitlist control group. The target population is Southern District Health Board (SDHB) catchment (including south Canterbury), Canterbury District Health Board (CDHB), and Capital and Coast District Health Board (CCDHB) adolescent patients with type 1 diabetes aged 13-20 years (inclusive), with a pre-study mean HbA1c of ≥ 80 mmol/mol in the previous six months.
This will be the first study to explore the effectiveness of FGM among adolescents who are struggling to monitor and maintain blood glucose levels in the ideal range. If the present study demonstrates clinically significant improvements in glucose testing frequency and glycaemic control among these participants, the data will support funding applications for larger and longer studies. Some of these studies could potentially focus on particular subpopulations to determine whether FGM should be integrated into regular and best practice care, with the expectation that more patients will experience improved glycaemic control and, in the long term, reduce their risk for diabetes-related complications. While glycaemic control is paramount, other salient outcomes may justify using FGM for purposes beyond glycaemic control, such as the possibility of improved quality of life, reduced treatment burden, and treatment satisfaction.
This study is supported by Cure Kids, Dunedin School of Medicine (DSM) Dean's Bequest, and a Dunedin School of Medicine Research Equipment Grant
Ethics approval number: Provisional approval, ethics ref 17/STH/240
Universal Trial Number (UTN): U1111-1205-5784
Australian New Zealand Clinical Trials Registry number: In progress
Dr Ben Wheeler
Dr Sara Boucher
Andrew Gray is the Biostatistician on the project.
Dr Martin de Bock
Dr Martin de Bock is a Paediatric Endocrinologist at Princess Margaret Hospital in Perth. He began working at the University of Otago, Christchurch in February 2018.
Associate Professor Esko Wiltshire
Professor Barbara Galland
Dr Paul Tomlinson
Jenny Rayns is a Diabetes Nurse Specialist for the Southern District Health Board.
Dr Karen Mackenzie
Dr Karen Mackenzie is a Paediatric Endocrinologist for the Canterbury District Health Board.