Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.
研究概览
简要总结
Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of these criteria should be present.
- •Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
- •HbA1c in the past three months ≤ 10%
- •Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
- •Age > 18 years
排除标准
- •Any of the following:
- •Patients with a diagnosis of type 1 diabetes
- •Hypoglycemia unawareness
- •Hypersensitivity to levemir
- •Hypersensitivity to NovoMix70
- •Creatinine > 2.5 mg/l
- •AST and or ALT > 1.5 times the upper limit
- •Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation
研究组 & 干预措施
Insulin treatment during Ramadan
Insulin analogs will be used: Levemir and NovoMix70. .
干预措施: Insulin treatment during Ramadan (Drug)
Standard treatment during Ramadan
Standard of care according to physicians choice
干预措施: Standard of care (Drug)
结局指标
主要结局
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.
时间窗: days 23-30 of treatment
次要结局
未报告次要终点