Abstract
PurposeFrequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control.MethodsThis open-label randomised controlled trial will enrol 100 children (4–13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58–110 mmol/mol [7.5–12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability.DiscussionThis research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes.Trial registrationThis trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).
Highlights
Extended author information available on the last page of the articleIn New Zealand, there are an estimated 2,500 youth aged 0–18 years living with type 1 diabetes [1,2,3]
The PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary scores have demonstrated excellent measurement properties and are recommended as useful standardised patient-reported outcomes of diabetes symptoms and diabetes management in clinical research in children with type 1 diabetes [37]
If generation intermittently scanned glucose monitoring (isCGM) is effective in an RCT, it will increase our ability to have this device available and funded for children worldwide
Summary
In New Zealand, there are an estimated 2,500 youth aged 0–18 years living with type 1 diabetes [1,2,3]. Journal of Diabetes & Metabolic Disorders mol [< 7.5%]) [5,6,7]. This increases their risk for short and long-term diabetes complications as shown by the Diabetes Care and Control Trial [8,9,10]. Frequent and timely self-monitoring of blood glucose (SMBG) is essential for guiding diabetes management decisions and keeping glucose levels in a safe range. Conventional SMBG involves finger-stick blood tests six or more times each day [11]. Children may infrequently perform SMBG because of social pressure to not be seen as ‘different’ [12], physical discomfort from pricking their fingers, and the technology is not user friendly (requires multiple steps to obtain a reading) [13]
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