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注册号: Registration number: |
ChiCTR2600121747 |
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最近更新日期: Date of Last Refreshed on: |
2026-04-02 11:05:20 |
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注册时间: Date of Registration: |
2026-04-02 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
中国1型糖尿病慢性并发症基线流行病学与评估研究 |
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Public title: |
Baseline Epidemiology and Assessment of Chronic Complications of Type 1 Diabetes in China |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
中国1型糖尿病慢性并发症基线流行病学与评估研究 |
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Scientific title: |
Baseline Epidemiology and Assessment of Chronic Complications of Type 1 Diabetes in China |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
段晓晔 |
研究负责人: |
郭立新 |
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Applicant: |
Duan Xiaoye |
Study leader: |
Guo Lixin |
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申请注册联系人电话: Applicant telephone: |
+86 10 6513 2266 |
研究负责人电话:
Study leader's |
+86 10 6513 2266 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
duanxiaoye1992@163.com |
研究负责人电子邮件: Study leader's E-mail: |
glx1218@163.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
北京市东城区东单大华路1号 |
研究负责人通讯地址: |
北京市东城区东单大华路1号 |
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Applicant address: |
1 Dahua Road, Dongdan, Dongcheng District, Beijing 100005, China |
Study leader's address: |
1 Dahua Road, Dongdan, Dongcheng District, Beijing 100005, China |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
北京医院 |
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Applicant's institution: |
Beijing Hospital |
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研究负责人所在单位: |
北京医院 |
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Affiliation of the Leader: |
Beijing Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2026BJYYEC-KY038-02 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
北京医院伦理委员会 |
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Name of the ethic committee: |
Research Ethics Committee of Beijing Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-02-09 00:00:00 | ||
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伦理委员会联系人: |
秦梓淋 |
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Contact Name of the ethic committee: |
Qin zilin |
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伦理委员会联系地址: |
北京市东城区东单大华路 1 号 |
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Contact Address of the ethic committee: |
1 Dahua Road, Dongdan, Dongcheng District, Beijing 100005, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 5811 5035 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
北京医院 |
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Primary sponsor: |
Beijing Hospital |
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研究实施负责(组长)单位地址: |
北京市东城区东单大华路 1 号 |
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Primary sponsor's address: |
1 Dahua Road, Dongdan, Dongcheng District, Beijing 100005, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
北京白求恩公益基金会 |
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Source(s) of funding: |
Beijing Bethune Public Welfare Foundation |
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研究疾病: |
1型糖尿病 |
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Target disease: |
Type 1 Diabetes |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
流行病学研究 |
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Study type: |
Epidemilogical research |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
1. 估计中国1型糖尿病患者人群大血管及微血管慢性并发症的患病率。 2. 初步探索中国1型糖尿病患者人群慢性并发症的风险因素。 3. 为政府制定1型糖尿病慢性发症预防控制策略和措施提供科学依据。 |
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Objectives of Study: |
1. To estimate the prevalence of macrovascular and microvascular chronic complications in the Chinese population with type 1 diabetes. 2. To preliminarily explore the risk factors for chronic complications in the Chinese population with type 1 diabetes. 3. To provide scientific evidence for the government to formulate strategies and measures for the prevention and control of chronic complications of type 1 diabetes. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
孕妇和患精神疾病者伴发1型糖尿病者。 |
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Exclusion criteria: |
Pregnant women and individuals with mental disorders with concurrent type 1 diabetes. |
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研究实施时间: Study execute time: |
从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-04-13 00:00:00 至 To 2027-09-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
1. 回顾性登记数据录入及质量控制: (1) 参与医院全面负责该地区病例登记的具体实施。 (2) 参加医院负责人定期向项目组报告下列项目:已经添加至登记系统的1型糖尿病患者人数,及录入的表格数量和质量; 2. 横断面调查数据核查和管理的内容和方式 参加医院负责人定期报告抽样病例完成并发症筛查、数据录入和标本采集情况。 3. 数据存档 原始表格将保存5年。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,将分类保存,并有多个备份保存于不同磁盘或记录介质上,防止丢失及损坏。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
1. Retrospective Registry Data Entry and Quality Control: (1) Participating hospitals are fully responsible for the specific implementation of case registration in the region. (2) The designated individual in charge of the participating hospitals regularly reports to the project team on the following items: the number of patients with type 1 diabetes added to the registry system, as well as the quantity and quality of the entered forms. 2. Content and Methods of Cross-Sectional Survey Data Verification and Management The individual in charge of the participating hospitals regularly reports on the progress of complication screenings, data entry, and specimen collection for the sampled cases. 3. Data Archiving Original forms will be preserved for five years. Electronic data files, including databases, inspection programs, analysis programs, analysis results, codebooks, and documentation files, will be categorized and stored. Multiple backups will be kept on different disks or recording media to prevent loss and damage. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |