NCT02821117已完成不适用
An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 20
- 主要终点
- Change in Time in Range
研究概览
简要总结
The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥4 years and ≤17 years.
- •Has an identified Caregiver of ≥18 years.
- •Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year.
- •Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen.
- •Currently testing BG, on average at least 2 times per day.
排除标准
- •Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
- •Currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study).
- •Currently receiving dialysis treatment or planning to receive dialysis during the study.
- •Female participant known to be pregnant.
- •Participating in another device or drug study that could affect glucose measurements or glucose management.
- •Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study.
- •Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months.
- •Known (or suspected) allergy to medical grade adhesives.
- •In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).
结局指标
主要结局
Change in Time in Range
时间窗: Baseline and days 56 to 70
Time in range (Sensor glucose 3.9-10.0 mmol/L \[70-180 mg/dL\]) in days 56-70 minus time in range at baseline (days 1-15).
次要结局
未报告次要终点
研究者
研究点 (20)
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