Edge Julie, Acerini Carlo, Campbell Fiona, Hamilton-Shield Julian, Moudiotis Chris, Rahman Shakeel, Randell Tabitha, Smith Anne, Trevelyan Nicola
Department of Paediatric Endocrinology and Diabetes, Oxford Children's Hospital, Oxford, UK.
The Weston Centre for Childhood & Adolescent Diabetes and Endocrinology, Addenbrooke's Hospital, Cambridge, UK.
Arch Dis Child. 2017 Jun;102(6):543-549. doi: 10.1136/archdischild-2016-311530. Epub 2017 Jan 30.
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.
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.
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.
NCT02388815.
确定FreeStyle Libre Flash葡萄糖监测系统在儿科人群中的准确性、安全性和可接受性。
设计、地点和患者：89名年龄在4至17岁的1型糖尿病研究参与者在英国的9个糖尿病中心入组。将经过工厂校准的传感器插入上臂背部，使用长达14天。将传感器测得的葡萄糖值与毛细血管血糖（BG）测量值进行比较。向参与者隐瞒传感器结果。
证明了传感器结果与BG结果的临床准确性，在共识误差网格的A区，83.8%的结果在此区域，在A区和B区，99.4%的结果在此区域。总体平均绝对相对差异（MARD）为13.9%。传感器准确性不受患者因素如年龄、体重、性别、胰岛素给药方法或使用时间（白天与夜间）的影响。参与者约50%的时间处于目标血糖范围（3.9至10.0 mmol/L）（平均每天12.1小时），低血糖和高血糖时平均分别为每天2.2小时和9.5小时。大多数参与者/护理人员对传感器的应用、设备的佩戴/使用以及与自我血糖监测的比较给予了好评（84.3 - 100%）。在不同年龄的参与者中报告了5起与设备相关的不良事件。
证明了FreeStyle Libre系统在儿科人群中的准确性、安全性和用户可接受性。该系统的准确性不受受试者特征的影响，使其适用于广泛的糖尿病儿童和青少年。
NCT02388815。
