A Randomized Controlled Large Study of Flexible Intensified Insulin Therapy (FIIT) With Carbohydrate Counting (CHC) Versus FIIT With Carbohydrate Counting and Automated Bolus Calculation (ABC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 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 Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.
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
- •Patients with type 1 diabetes
- •Age >18 years
- •Diabetes duration more than 12 months
- •Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
- •HbA1c between 8.0% and 11.3%
排除标准
- •Present or former practice of carbohydrate counting
- •Gastroparesis
- •Pregnancy or nursing
研究组 & 干预措施
ACC
Training in advanced carbohydrate counting
干预措施: Advanced Carbohydrate Counting (Behavioral)
ACC + ABC
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
干预措施: Automated bolus calculator (Device)
ACC + ABC
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
干预措施: Advanced Carbohydrate Counting (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 12 months
次要结局
- Frequency of serious hypoglycemic events(Baseline, 12 months)
研究者
Eva Hommel
Senior Consultant
Steno Diabetes Center Copenhagen