Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Glucose time
研究概览
简要总结
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.
详细描述
Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •type 1 diabetes for > 1 year
- •on using closed-loop hybrid insulin administration
- •scheduled Ramadan fasting
- •patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
- •percentage of continuous glucose monitoring sensor wear > 70% in at least one of the two 30-day periods
排除标准
- •patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
- •patient who is pregnant or wants to become pregnant immediately
- •patient informed of the study who objected to the collection of his/her data.
结局指标
主要结局
Glucose time
时间窗: Day 30
time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period
次要结局
- Glucose time(Day 60)