Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2,104
- 试验地点
- 1
- 主要终点
- routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)
研究概览
简要总结
This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.
详细描述
The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Provision of signed written informed consent
- •Age of 18 years or older
- •Diagnosis of Type 2 Diabetes Mellitus (T2DM)
排除标准
- •Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.
研究组 & 干预措施
Type 2 Diabetes Mellitus
Patients with antidiabetic treatment for Type 2 Diabetes Mellitus
干预措施: antidiabetic treatment (ATC A10B) (Drug)
结局指标
主要结局
routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)
时间窗: From date of registration every 3 months until end of study (up to 120 months)
The objective of the project is to develop a sustainable Type 2 Diabetes Mellitus (T2DM) registry to collect daily routine treatment data (e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) to provide a better understanding of the disease specific epidemiology, treatment patterns, patient relevant outcomes, patient subgroups, specifically among patients with Type 2 Diabetes Mellitus. Further DDG ("Deutsche Diabetes Gesellschaft") guideline adherence and economic aspects of diabetes treatment should be evaluated on the basis of this registry data.
次要结局
未报告次要终点