NCT01223547已完成不适用
The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Diabetes duration at least 12 months
- •MDI therapy
- •HbA1c 8-10,5% (both included)
排除标准
- •Gastroparesis
- •Present or former practice of carbohydrate counting
- •Pregnancy or nursing
研究组 & 干预措施
Control group
No Intervention
Participants in this arm continues their usual insulin therapy
Carb counting
Active Comparator
Participants in this arm are taught carb counting
干预措施: Education (Other)
Carb counting and bolus calculator
Active Comparator
Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
干预措施: Education (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 4 months
次要结局
- Total daily insulin dose(4 months)
- Treatment satisfaction(4 months)
- Weight(4 months)
- Variation in blood glucose(4 months)
- Number of hypoglycemic events(4 months)
研究者
Signe Schmidt
MD
Hvidovre University Hospital
研究点 (1)
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