ArticleJournal of diabetes and metabolic disorders2021
A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol.
Article in Journal of diabetes and metabolic disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbADiabetic medicine : a journal of the British Diabetic Association · 2025Trial
- Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.Diabetes technology & therapeutics · 2023Trial
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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. DISCUSSION: This 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).
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