Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Incidence of hypoglycemia
研究概览
简要总结
Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan
The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥14 years
- •Patients on insulin pump (more than 3 months)
- •Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
- •Diagnosis of type 1 DM of more than 6 months.
- •Willing to do Self Monitoring Blood Sugar (SMBG)
- •Have no other contraindication to fast
排除标准
- •Patient with renal or hepatic impairment
- •Patient with diagnosed adrenal insufficiency
- •Any diagnosed psychiatric disease
- •Can not do SMBG
结局指标
主要结局
Incidence of hypoglycemia
时间窗: 5 weeks
Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users \[Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)\]
次要结局
- Number of fasting days lost(5 weeks)
- Glycemic control(Two (2) months)
- Rate of acute complications(5 weeks)
- overnight hypoglycemia(5 weeks)
研究者
Reem Mohammad Alamoudi
Consultant Endocrinology
King Abdullah International Medical Research Center