The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus：A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- time in range at Week 8 after enrollment
研究概览
简要总结
The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus
详细描述
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with gestational diabetes
- •18-45 years old
- •24-28 weeks gestation of pregnancy
- •singleton pregnancy
- •BMI≥18kg/m2
排除标准
- •pregestational type 1 or 2 diabetes mellitus
- •aged <18 or >45 years
- •BMI<18kg/m2
- •multiple pregnancy
- •Cushing's syndrome/ using exogenous steroids
- •chronic infection ( HIV, Hepatitis B/C, Tuberculosis)
- •any active chronic systemic disease ( except essential hypertension)
- •Severe liver and kidney dysfunction
研究组 & 干预措施
Continuous Glucose Monitoring System
干预措施: Continuous Glucose Monitoring System (Device)
结局指标
主要结局
time in range at Week 8 after enrollment
时间窗: at Week 8 after enrollment
time in range of CGMS at Week 8 after enrollment
次要结局
- the level of HbA1c before delivery(37 weeks of gestation)
- adverse pregnancy outcomes(3 month)
- the incidence of hypoglycemic events(14 weeks)
研究者
Yufan Wang
Director of endocrinology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine