Objective To determine accuracy, safety and acceptability of the FreeStyle Libre Flash Glucose Monitoring System in the paediatric population.
Design, setting and patients Eighty-nine study participants, aged 4–17 years, with type 1 diabetes were enrolled across 9 diabetes centres in the UK. A factory calibrated sensor was inserted on the back of the upper arm and used for up to 14 days. Sensor glucose measurements were compared with capillary blood glucose (BG) measurements. Sensor results were masked to participants.
Results Clinical accuracy of sensor results versus BG results was demonstrated, with 83.8% of results in zone A and 99.4% of results in zones A and B of the consensus error grid. Overall mean absolute relative difference (MARD) was 13.9%. Sensor accuracy was unaffected by patient factors such as age, body weight, sex, method of insulin administration or time of use (day vs night). Participants were in the target glucose range (3.9–10.0 mmol/L) ∼50% of the time (mean 12.1 hours/day), with an average of 2.2 hours/day and 9.5 hours/day in hypoglycaemia and hyperglycaemia, respectively. Sensor application, wear/use of the device and comparison to self-monitoring of blood glucose were rated favourably by most participants/caregivers (84.3–100%). Five device related adverse events were reported across a range of participant ages.
Conclusions Accuracy, safety and user acceptability of the FreeStyle Libre System were demonstrated for the paediatric population. Accuracy of the system was unaffected by subject characteristics, making it suitable for a broad range of children and young people with diabetes.
Trial registration number NCT02388815.
- General Paediatrics
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Contributors Abbott Diabetes Care planned and funded (including provision of devices) the study described in the article. Prior to initiation of the study, site clinical staff were trained in use of the device by clinical staff from Abbott Diabetes Care. The study was conducted at the following sites: Oxford Children's Hospital, principal investigator: JE, Addenbrooke's Hospital, principal investigator: CA, Leeds Children's Hospital, principal investigator: FC, Bristol Royal Hospital for Children, principal investigator: JH-S, Royal Devon and Exeter NHS Foundation Trust, principal investigator: CM, Harrogate District Hospital, principal investigator: SR, Nottingham University Hospitals NHS Trust, principal investigator: TR, Northampton General Hospital, principal investigator: AS, Southampton General Hospital, principal investigator: NT. The Paediatric Diabetes and Endocrinology Team, in particular Loraine Bunton and Jane Bowen-Morris, at Oxford Children's Hospital aided in the design of the participant information sheets prior to submission to the ethics board. The NIHR Young Persons’ Advisory Group, Liverpool Regional Group, critically reviewed the design and content of participant information sheets prior to submission to the ethics board. Study staff at each site contributed to data collection. The principal investigator at each site contributed to the writing of the original article.
Funding Abbott Diabetes Care.
Competing interests All authors' institutions received financial support from Abbott Diabetes Care to conduct the clinical trial. TR received honoraria/fees for consulting from Abbott Diabetes Care outside of the submitted work. The study sponsor (Abbott Diabetes Care) designed the study protocol in collaboration with the principal investigator and provided all study materials. The sponsor was involved in collecting data and reporting results. The sponsor also gave approval to submit for publication. The corresponding author had full access to all the data in the study and, together with all authors, had final responsibility for the decision to submit for publication.
Ethics approval West Midland, Edgbaston Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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