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临床试验/NCT02574195
NCT02574195已完成不适用

Evolution of Effectiveness of Diabetes Medical Care in Russia

Endocrinology Research Centre, Moscow1 个研究点 分布在 1 个国家目标入组 599 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
599
试验地点
1
主要终点
Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications

研究概览

简要总结

The main aim of the present study is to evaluate the prevalence of individual microvascular and macrovascular complications among diabetes mellitus patients and to determine the percentage of diabetes mellitus patients achieved HbA1c<7,0%.

详细描述

Rationale for this Study Primary Existing routine health statistics underestimates the rate of morbidity due to diabetes complications. To provide more realistic estimation of morbidity, repeated epidemiological studies are essential in assessment of tendencies in diabetes medical care at the country level. They allow to reveal issues, which, being resolved, can contribute to the improvement of diabetes medical care effectiveness. Guidelines developed with this study data may save healthcare budgets and prevent financial losses due to diabetes-related morbidity and disability.

Objectives of the Study • Primary objective: To determine the prevalence of individual microvascular and macrovascular complications among patients with diabetes mellitus type 1 and type 2

• Secondary objective: To determine the percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7,0%.

Study design The hired medical team (9 specialists) is going to perform the technical study-related tasks in Moscow Region.

Target population includes approximately 147,000 diabetes mellitus patients included in Regional Diabetes Mellitus Register, from which patients will be selected via random sampling (600 patients).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications

时间窗: 30 days

macrovascular complications, i.e. with history of * chronic heart disease * myocardial infarction * ischaemic stroke * transient ischemic attack * any revascularization procedure * any peripheral atherosclerosis e) microvascular complications, i.e. * diabetic retinopathy * diabetic neuropathy * albuminuria * chronic kidney disease stage f) other complications diagnosed after diabetes mellitus has been established, i.e. * foot examination findings

次要结局

  • The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%(30 days)
  • Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)(30 days)

研究者

发起方
Endocrinology Research Centre, Moscow
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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