Assessment of Blood Glucose Monitoring Devices With New Insight Features
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 267
- 试验地点
- 6
- 主要终点
- A1c change from baseline after 12 weeks
研究概览
简要总结
To investigate whether novel insight features in new BGMs can improve glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
- •Currently performing SMBG at home for diabetes management decisions
- •Willingness to notify the study staff if they become pregnant during the study
- •Willing to sign an informed consent
排除标准
- •Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
- •Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
- •Conflict of Interest
研究组 & 干预措施
OneTouch Verio®
Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks
干预措施: OneTouch Verio® (Device)
Control
Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.
干预措施: Subject's Own Blood Glucose Meter (Device)
Intervention 02
Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.
干预措施: OneTouch Verio® Flex (Device)
结局指标
主要结局
A1c change from baseline after 12 weeks
时间窗: 12 weeks
A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.
次要结局
未报告次要终点