基于人工智能深度学习算法的2型糖尿病无创筛查和临床决策支持研究

注册号:

Registration number:

ChiCTR1900021480 

最近更新日期:

Date of Last Refreshed on:

2019-02-23 09:36:30 

注册时间:

Date of Registration:

2019-02-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于人工智能深度学习算法的2型糖尿病无创筛查和临床决策支持研究

Public title:

Non-invasive Screening and Clinical decision support for type 2 diabetes based on artificial intelligence deep learning algorithm

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于人工智能深度学习算法的2型糖尿病无创筛查和临床决策支持研究

Scientific title:

Non-invasive Screening and Clinical decision support for type 2 diabetes based on artificial intelligence deep learning algorithm

研究课题代号(代码):

Study subject ID:

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:

申请注册联系人:

张策 

研究负责人:

张策 

Applicant:

Ce Zhang 

Study leader:

Ce Zhang 

申请注册联系人电话:

Applicant telephone:

+86 17709873135

研究负责人电话:

Study leader's
telephone:

+86 17709873135

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

zhangce88@126.com

研究负责人电子邮件:

Study leader's E-mail:

zhangce88@126.com

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):

申请注册联系人通讯地址:

辽宁省大连市沙区中山路467号大连医科大学附属第二医院学科建设与科研管理部

研究负责人通讯地址:

辽宁省大连市沙区中山路467号大连医科大学附属第二医院学科建设与科研管理部

Applicant address:

467 Zhongshan Road, Shaqu District, Dalian, Liaoning, China

Study leader's address:

467 Zhongshan Road, Shaqu District, Dalian, Liaoning, China

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:

申请人所在单位:

大连医科大学附属第二医院

Applicant's institution:

The Second Hospital of DaLian Medical University

研究负责人所在单位:

大连医科大学附属第二医院

Affiliation of the Leader:

The Second Hospital of DaLian Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

大医二院伦审2019第020号

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

大连医科大学附属第二医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Second Affiliated Hospital of Dalian Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-14 00:00:00

伦理委员会联系人:

师明阳

Contact Name of the ethic committee:

Mingyang Shi

伦理委员会联系地址:

辽宁省大连市沙区中山路467号大连医科大学附属第二医院

Contact Address of the ethic committee:

467 Zhongshan Road, Shaqu District, Dalian, Liaoning, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

大连医科大学附属第二医院

Primary sponsor:

The Second Hospital of DaLian Medical University

研究实施负责(组长)单位地址:

辽宁省大连市沙区中山路467号

Primary sponsor's address:

467 Zhongshan Road, Shaqu District, Dalian, Liaoning, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁

市(区县):

大连

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

大连医科大学附属第二医院

具体地址:

辽宁省大连市沙区中山路467号

Institution
hospital:

The Second Hospital of DaLian Medical University

Address:

467 Zhongshan Road, Shaqu District, Dalian, Liaoning, China

经费或物资来源:

自筹经费

Source(s) of funding:

Self-financing

研究疾病:

2型糖尿病  

Target disease:

type 2 diabetes mellitus

研究疾病代码:

Target disease code:

研究类型:

筛查

Study type:

Screening

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

单臂 

Study design:

Single arm 

研究目的:

通过本课题的人工智能算法的探索,可以充分利用医院已经形成的大数据资源,从中提取有用的算法,用于临床2型糖尿病的精准治疗。算法形成后,将以手机APP等程序作为载体,实现人工智能转化,通过人机对话系统,为2型糖尿病的I级预防提供帮助,并辅助医生临床决策,帮助患者疾病管理。具有一定的经济和社会意义。  

Objectives of Study:

Through the exploration of the artificial intelligence algorithm of this subject, we can make full use of the big data resources that the hospital has formed, and extract useful algorithms for the accurate treatment of clinical type 2 diabetes. After the algorithm is formed, the program such as mobile APP will be used as a carrier to realize the transformation of artificial intelligence, help the level I prevention of type 2 diabetes through the human-machine dialogue system, and assist the doctor in clinical decision-making to help patients with disease management. It has certain economic and social significance.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

人工智能大数据研究中,基于TensorFlow算法进行大数据运算,在数据清洗阶段针对缺失值、异常值和离群值等进行数据清洗,排除掉极端数据进行建模计算。

Exclusion criteria:

In the research of artificial intelligence big data, the TensorFlow algorithm is used for big data operation. In the data cleaning stage, data is cleaned for missing values, outliers, and extreme data is excluded for modeling calculation.

研究实施时间:

Study execute time:

From 2019-04-01 00:00:00 To 2021-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2019-04-01 00:00:00 To 2019-03-31 00:00:00

干预措施:

Interventions:

组别:

糖尿病血糖控制好/不好

样本量:

250000

Group:

Control of diabetes blood sugar is good / bad

Sample size:

干预措施:

回顾性观察

干预措施代码:

Intervention:

Retrospective observation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

辽宁省 

市(区县):

大连市 

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

大连医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Hospital of DaLian Medical University

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

Blood sugar

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

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

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

原始数据不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Raw data is not shared

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:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-02-23 09:36:30