Incidence of Hypoglycemia in Pregnant Women With or Without Diabetes During Fasting in Ramadan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hypoglycemia incidence with fasting
研究概览
简要总结
The physiological change in food and sleep pattern during Ramadan impacted hypoglycemia risks among pregnant women. Few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in Ramadan in Saudi Arabia. This study aims to understand the glucose variability in pregnant women during fasting Ramadan in Saudi Arabia.
详细描述
Women with normal pregnancy will be compared to women with gestational diabetes on diet or Metformin alone during Fasting Ramadan. They will be monitored and will be observed for incidence of hypoglycemia using continuous glucose monitoring devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old.
- •Pregnant women without diabetes.
- •Pregnant women with diabetes (pregestational and gestational) on diet +/- metformin.
- •Dedicated to applying a continuous glucose monitoring (CGM) device.
排除标准
- •Age below18 years
- •Pregnant women with diabetes on insulin (type 1 and type 2 diabetes)
- •Renal and liver impairment.
- •Adrenal insufficiency
- •Psychiatric diseases.
结局指标
主要结局
Hypoglycemia incidence with fasting
时间窗: 1 month
To estimate the incidence of hypoglycemia defined as blood glucose \< 70 mg/dl during fasting in pregnant women with gestational diabetes on diet therapy or metformin alone compared to women without diabetes
次要结局
- Time above range (TAR)(1 month)
- Time below range (TBR)(1 month)
- Time in range (TIR)(1 month)
- Glucose variability during fasting Ramadan(1 month)
- Number of days that needed to break fasting(1 month)