NCT00569452已完成不适用
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
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
- 12
- 试验地点
- 1
- 主要终点
- Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
研究概览
简要总结
This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Adult patients >= 18 years of age
- •Type 1 diabetes
- •Diabetic for >2 years, and treated with CSII for >= 3 months
- •HbA1c <=8.5%
排除标准
- •Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
- •Unstable chronic disease other than type 1 diabetes
- •Severe hypoglycemic event within last week prior to study start
- •Severe diabetic ketoacidosis within last month prior to study start
研究组 & 干预措施
A
Experimental
干预措施: Accu-Chek Spirit Insulin Pump (Device)
B
Experimental
干预措施: Accu-Chek Spirit Insulin Pump (Device)
结局指标
主要结局
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
时间窗: Study duration
次要结局
- AUC, MAGE, HbA1c, body weight change(Study duration)
研究者
研究点 (1)
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