NCT02887898已完成不适用
Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study
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
- 80
- 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-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.
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
- •Type 2 diabetes > 1 year
- •Age 18 years or older
- •HbA1C > 64 mmol/mol (8.0 %)
- •Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months
- •GAD-antibody negative
- •Naïve to bolus calculators
排除标准
- •Pregnancy or breast feeding
- •Gastroparesis
- •Severe nephropathy (eGFR<30 mL/min/1,73 m2)
- •Use of sulfonylurea
研究组 & 干预措施
Carb counting and bolus calculator
Active Comparator
Education in carb counting and the use of an automated bolus calculator
干预措施: Automated bolus calculator (Device)
Carb counting and bolus calculator
Active Comparator
Education in carb counting and the use of an automated bolus calculator
干预措施: Education (Other)
Carb counting
Placebo Comparator
Education in carb counting and manual calculation of insulin bolus
干预措施: Education (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
次要结局
- Change in treatment satisfaction(6 months)
- Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM)(6 months)
- Change in diet habits/diet composition(6 months)
- Frequency of blood glucose measurements assessed by meter download before randomization and at each visit(6 months)
- Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)(6 months)
研究者
Merete Bechmann Christensen
MD
Hvidovre University Hospital
研究点 (1)
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