The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Jena、德国、07740
- Friedrich-Schiller-University, department of internal medicine III
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes mellitus
- Aged 40 - 80 years
- Therapy with human insulin
Exclusion Criteria:
- Pregnancy
- Nutrition disorders
- Psychological disease
- Body Mass Index (BMI) less than 25 kg/m^2
- HbA1c greater than 9%
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：A
with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month
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The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks. |
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实验性的：B
without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month
|
The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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HbA1c
大体时间：Week 16 and 28
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Week 16 and 28
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Hypoglycemia
大体时间：Week 16 and 28
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Week 16 and 28
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Treatment satisfaction
大体时间：week 16 and 28
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week 16 and 28
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|
Quality of Life
大体时间：week 16 and 28
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week 16 and 28
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合作者和调查者
调查人员
- 首席研究员：Ulrich A Mueller, Professor、University of Jena, department of internal medicine III
出版物和有用的链接
一般刊物
- Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
- Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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