Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- postprandial glycaemia
研究概览
简要总结
A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.
The aim of the investigators study is to assess if these results are confirmed in a clinical trial.
The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
- •with confirmed Negative C-peptide or diabetes duration>5 years
- •Treated by external insulin pump and rapid insulin analog for more than 3 months
- •using a Medtronic Paradigm Real-Time or Veo™ model
- •Educated to and practicing functional insulin treatment and carbohydrate counting for more than 3 months
- •Able to use the "basal temp" and "glycaemia reminder" functions of their pump
- •Basal infusion rate ≥ 0,5 Unit/h
- •Self-monitoring of blood glucose frequency > 4/days
- •Aware of hypoglycaemia
排除标准
- •known impaired renal function (creatinin clearance <60ml/min)
- •Gastroparesis
- •Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids
研究组 & 干预措施
Normal then Coordinated
normal bolus during 2 weeks then coordinated bolus during 2 weeks
干预措施: Normal bolus (Drug)
Normal then Coordinated
normal bolus during 2 weeks then coordinated bolus during 2 weeks
干预措施: Coordinated bolus (Drug)
Coordinated then Normal
coordinated bolus during 2 weeks then normal bolus during 2 weeks
干预措施: Normal bolus (Drug)
Coordinated then Normal
coordinated bolus during 2 weeks then normal bolus during 2 weeks
干预措施: Coordinated bolus (Drug)
结局指标
主要结局
postprandial glycaemia
时间窗: 2 hours after eating during 4 weeks
measured by Self Monitoring of Blood Glucose
次要结局
- mean glycaemia(before eating and 2 hours after eating during 4 weeks)
- adverse events(Throughout the study (4 weeks))
- severe hypoglycaemia frequency(Throughout the study (4 weeks))
- frequency of glycaemia < or = 60mg/dl(before eating and 2 hours after eating during 4 weeks)
- insulin doses(basal rate and boluses)
- frequency of glycaemia between 61-140mg/dl(before eating and 2 hours after eating during 4 weeks)
- standard deviation of glycaemia(before eating and 2 hours after eating during 4 weeks)
- frequency of glycaemia >140mg/dl(before eating and 2 hours after eating during 4 weeks)
- mean glycemia(Throughout the day during 4 weeks)
- standard deviation(Throughout the day during 4 weeks)
- time spent within glucose range < or = 60mg/dl(Throughout the day during 4 weeks)
- time spent within glucose range between 61-140mg/dl(Throughout the day during 4 weeks)
- time spent within glucose range mg/dl(Throughout the day during 4 weeks)
- fructosamine(day 1 + 4 weeks)