The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- HbA1c (Glycated hemoglobin)
研究概览
简要总结
Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.
详细描述
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above).
Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7- 18 years old
- •type 1 diabetes mellitus for over 1 year
- •treatment with insulin pump with bolus calculator function
- •HbA1c < 10%
- •expressed written informed consent
排除标准
- •recall the consent
结局指标
主要结局
HbA1c (Glycated hemoglobin)
时间窗: 3 months
次要结局
- Frequency of meal boluses(3 months)
- Post- prandial glycaemia(2 hours after the meals)
- Hypoglycaemia episodes and severe hypoglycaemia events(3 months)
- Frequency of self- blood glucose monitoring(3 months)
- Treatment satisfaction(3 months)
- Hyperglycaemic episodes(3 months)
- Frequency of bolus calculator using(3 months)