Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of glycemia
研究概览
简要总结
The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.
详细描述
The functional insulin therapy is a method for adjusting insulin doses which tends to mimic the physiology, especially when food intake with proportional dose calculation to the amount of carbohydrates ingested by the use of ratios. This method of adaptation, increasingly used in France, is an extension in the use of subcutaneous insulin pump with a more precise determination of bolus doses with meals, and use of aids dose calculations (assistant wizard for instance). In practice every day, some patients perform their bolus immediately after eating, not just before, allowing them to know exactly the amount of ingested carbohydrates and not the one provided in advance.
This study is very interesting because it allows to compare the injection of an analogous bolus of fast insulin before and after the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients with type 1 diabetes treated with insulin pump.
排除标准
- •Unbalanced diabetes,
- •Ongoing pregnancy known,
- •Gastrointestinal neuropathy known,
- •Chronic medical illness and psychiatric
研究组 & 干预措施
Group 1
Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF).
Intervention: drug (insulin Aspart)
干预措施: Insulin Aspart (Drug)
Group 2
Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE).
Intervention: drug (insulin Aspart)
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Area Under Curve (AUC) of glycemia
时间窗: During 14 days
Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
次要结局
- Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability(During 14 days)
- Area Under Curve (AUC) during 4H after a high-fat meal(4 hours)