Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Hypoglycemia incidence
研究概览
简要总结
To compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan.
详细描述
The investigators aim to compare the effectiveness and safety of two management strategies currently used in basal insulin adjustment for treatment of Type1 diabetes (T1DM) during fasting the holy month of Ramadan.
Primary Objective:
To determine if taking basal insulin Glargine at 6 pm is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia ) - compared to bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM
Secondary Objectives:
- To estimate the difference between the two groups in glucose variability
- To estimate the difference between the two groups in number of days they needed to brake their fast
- To assess the difference in glycemic control between the two groups
- To estimate the difference between the two groups in overnight and daytime hyperglycemia.
- To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 14 years
- •Diagnosis of type 1 DM of more than 6 months.
- •Committed to do SMBG
排除标准
- •Renal and hepatic impairment
- •Adrenal insufficiency
- •Alcohol consumption
- •Any diagnosed psychiatric disease
结局指标
主要结局
Hypoglycemia incidence
时间窗: Through study completion, an average of 3 months
To determine if taking basal insulin Glargine at 6 pm is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia ) - compared to bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM.
次要结局
- Glucose variability(Through study completion, an average of 3 months)
- Hyperglycemia(Through study completion, an average of 3 months)
- Acute diabetes complications(Through study completion, an average of 3 months)
- Days fast broken(Through study completion, an average of 3 months)
- Glycemic control(Through study completion, an average of 3 months)