NCT04605497已完成不适用
A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Average time-in-range over a 24 hour period
研究概览
简要总结
The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •Singleton pregnancy ≥20 weeks gestation
- •Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
- •Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver
排除标准
- •Chronic immunosuppression
- •Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
- •Known allergy to medical grade adhesives
- •Pre-gestational diabetes
- •Multifetal gestation
- •Current alcohol or illicit drug use
- •Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.
结局指标
主要结局
Average time-in-range over a 24 hour period
时间窗: From enrollment to10 days after discharge from hospital following delivery
次要结局
- Average time-in-range during waking hours(From enrollment to10 days after discharge from hospital following delivery)
- Average time-in-range while asleep(From enrollment to10 days after discharge from hospital following delivery)
研究者
Amy Miyoshi Valent
Assistant Professor
Oregon Health and Science University
研究点 (2)
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