NCT00313742已完成4 期
An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise
研究概览
简要总结
This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.
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
- •Current basal-bolus insulin therapy
- •HbA1c < 10%
- •BMI < 32 kg/m2
排除标准
- •Proliferative Retinopathy / Maculopathy
- •Recurrent major hypoglycaemias
- •Impaired hepatic or renal function
- •Cardiac Problems
- •Uncontrolled hypertension
结局指标
主要结局
The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise
时间窗: following 4 weeks of treatment
次要结局
- Plasma glucose pre-exercise & post-exercise
- Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning
- Plasma glucose profile post-exercise
- Incidence of adverse events during the trial
研究者
研究点 (2)
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