Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Change in HbA1C From Baseline to 6 Months
研究概览
简要总结
To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.
详细描述
Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period of 20 days at the start of the study, after which their Healthcare Professionals (HCPs) may recommend changes to their glucose management based on the continuous glucose monitoring(CGM) data. Subjects will then return to self-managing their diabetes with a blood glucose meter. After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review their results and glucose management with their HCPs. Subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic variability are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for >1yr)
- •Age 18-65 years
- •HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment
- •Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment.
- •Testing Blood Glucose ≥ 4 times a day for previous 12 months
排除标准
- •Subject is currently on an insulin pump.
- •Subject has known allergy to medical grade adhesives
- •Subject has concomitant disease that influences metabolic control
- •Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- •Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring.
- •Subject is receiving peritoneal dialysis solutions containing icodextrin
- •Subject is pregnant / planning to become pregnant during study
结局指标
主要结局
Change in HbA1C From Baseline to 6 Months
时间窗: Baseline and 6 months
HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)
次要结局
- Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%(Baseline and 6 months)
- Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked(Baseline & 6 months)
- Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked(2 weeks following baseline & 3 months)