The Effectiveness of Flash Glucose Monitoring System on Glycemic Control in Patients With New-onset Type 2 Diabetes#A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the between-group difference in mean HbA1c
研究概览
简要总结
The purpose of this study is to determine if Flash glucose monitoring system improves glycemic control in adults with new-onset type 2 diabetes
详细描述
People with new-onset type 2 diabetes who achieve and sustain glycemic targets is important for reducing the risk of complications and all-cause mortality.Glucose monitoring is the key point of diabetes management.Continuous glucose monitoring(CGM)can identify day-to-day glucose profiles to guide management decisions.Flash glucose monitoring is a variant of CGM and is factory calibrated,requiring no finger pricks.The purpose of this study is to determine if Flash glucose monitoring improves glycemic control in adults with new-onset type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peolpe with type 2 diabetes in accordance with the dignosed criteria of CDS2017
- •type 2 diabetes duration of <6months
- •with certain read-write ability
- •willing to use FSL or follow study protocol
排除标准
- •acute complication of diabetes condition(DKA,HHH)
- •pregnancy,lactating or planning pregnancy
- •allergy to adhesive tape
- •skin with large area of rubefaction and wounds
结局指标
主要结局
the between-group difference in mean HbA1c
时间窗: 3months
difference in mean HbA1c between FSL group and SMBG group
次要结局
- the between-group difference in mean time in hypoglycemia(3months)
- the between-group difference in mean time in other biochemical indexes,such as LDL-C,TC,TG and so on(3months)
- the between-group difference in mean time in target glucose range(3months)
研究者
Yufan Wang
Director of endocrinology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine