今天是:2019-06-17 星期一

实时动态葡萄糖监测系统的性能评价关键研究(中国)
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注册号:

Registration number:

ChiCTR1900022106 

最近更新日期:

Date of Last Refreshed on:

2019-03-25 

注册时间:

Date of Registration:

2019-03-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

实时动态葡萄糖监测系统的性能评价关键研究(中国) 

Public title:

A Pivotal Study to Evaluate Guardian Connect CGM System Performance in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

实时动态葡萄糖监测系统的性能评价关键研究(中国) 

Scientific title:

A Pivotal Study to Evaluate Guardian Connect CGM System Performance in China 

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:

伯坚 

研究负责人:

伯坚 

Applicant:

Bo Jian 

Study leader:

Bo Jian 

申请注册联系人电话:

Applicant telephone:

+86 158 1139 1874 

研究负责人电话:

Study leader's telephone:

+86 158 1139 1874 

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:

jian.bo@medtronic.com 

研究负责人电子邮件:

Study leader's E-mail:

jian.bo@medtronic.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:

北京市朝阳区光华路9号世贸天阶天阶大厦D座 

研究负责人通讯地址:

北京市朝阳区光华路9号世贸天阶天阶大厦D座 

Applicant address:

23rd Floor, Block D, The Place Tower, 9 Guanghua Road, Chaoyang District, Beijing, China 

Study leader's address:

23rd Floor, Block D, The Place Tower, 9 Guanghua Road, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100020 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

美敦力(上海)管理有限公司 

Applicant's institution:

Medtronic (Shanghai) Management Co., Ltd. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018-0650(1) 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-26 

伦理委员会联系人:

龚小玉 

Contact Name of the ethic committee:

Gong Xiaoyu 

伦理委员会联系地址:

中国上海市宜山路600号19号楼 

Contact Address of the ethic committee:

Building 19, 600 Yishan Road, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021 24056428 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

liuyuanec@163.com 

研究实施负责(组长)单位:

上海市第六人民医院 

Primary sponsor:

Shanghai Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市宜山路600号 

Primary sponsor's address:

600 Yishan Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

美敦力(上海)管理有限公司

具体地址:

浦东新区东育路255弄5号前滩世贸中心

Institution
hospital:

Medtronic (Shanghai) Management Co., Ltd.

Address:

11th Floor, Building B, 5, Lane 255, DongYu Road, Pudong District

经费或物资来源:

美敦力(上海)管理有限公司 

Source(s) of funding:

Medtronic (Shanghai) Management Co., Ltd. 

研究疾病:

1型糖尿病,2型糖尿病 

Target disease:

Type 1 diabetes, Type 2 diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究的主要目的是证明Guardian Sensor (3)葡萄糖探头配合实时动态葡萄糖监测系统时的性能和安全性,插入受试者腹部使用170小时(7天),受试者年龄为14-75岁。 本研究的次要目的是采集可表明Guardian Sensor (3)葡萄糖探头与以下系统一起使用时的准确性的数据: MiniMed 600G/700G系列胰岛素泵系统 Envision系统 

Objectives of Study:

The primary purpose of this study is to demonstrate the performance and safety of the Guardian Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects aged 14-75 years with the Guardian Connect System. The secondary purpose of this study is to collect data that will be used to characterize the accuracy of the Guardian Sensor (3) when used with the following systems: MiniMed 600G/700G series insulin pump systems Envision system 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 筛查时,受试者年龄为14-75岁。 2. 受试者患有临床诊断的1或2型糖尿病,通过医疗记录或由有资格进行医学诊断的个人提供的源文件来确定。 3. 受试者具有足够的静脉通路,由研究者或适当的工作人员评估。 4. 受试者愿意遵循研究程序,并愿意进行研究访视。 

Inclusion criteria

1. Subject is 14 - 75 years of age at time of screening. 2. Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 3. Subject has adequate venous access as assessed by investigator or appropriate staff. 4. Subject is willing to follow the study procedures and willing to come to study visits. 

排除标准:

1. 受试者不能耐受Guardian Sensor (3)葡萄糖探头放置区域的胶带,由有资质的个人评估。 2. 受试者在研究器械或器械放置区域患有任何未痊愈的不良皮肤病(例如,牛皮癣、皮疹、葡萄球菌感染)。 3. 受试者正积极参与一项调查型研究(药物或器械),其中他们在过去2周内接受了调查型研究(药物或器械)的治疗。 4. 受试者为女性,并且妊娠筛查测试结果为阳性。 5. 如果未使用研究者认为可靠的避孕措施,则应排除育龄女性和性活跃的女性。 6. 受试者是女性,并计划在研究过程中怀孕。 7. 受试者的血细胞压积(Hct)低于正常参考范围。 8. 受试者不可为进行这项研究的研究人员。 

Exclusion criteria:

1. Subject will not tolerate tape adhesive in the area of Guardian? Sensor (3) placement as assessed by qualified individual. 2. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection). 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks. 4. Subject is female and has a positive pregnancy screening test. 5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator. 6. Subject is female and plans to become pregnant during the course of the study. 7. Subject has a hematocrit (Hct) lower than the normal reference range. 8. Subject may not be on the research staff of those performing this study. 

研究实施时间:

Study execute time:

From2018-11-11To 2019-12-31 

干预措施:

Interventions:

组别:

单组

样本量:

72

Group:

Single-arm

Sample size:

干预措施:

Guardian Sensor (3)葡萄糖探头配合实时动态葡萄糖监测

干预措施代码:

Intervention:

Guardian Sensor with the Guardian Connect System

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

解放军总医院第七医学中心 

单位级别:

三级甲等 

Institution
hospital:

The Seventh Medical Center of PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血细胞压积

指标类型:

主要指标 

Outcome:

HCT

Type:

Primary indicator 

测量时间点:

访视1

测量方法:

血液学检测

Measure time point of outcome:

Visit 1

Measure method:

Blood test

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

A1C

Type:

Primary indicator 

测量时间点:

访视1

测量方法:

血液学检查

Measure time point of outcome:

Visit 1

Measure method:

Blood test

指标中文名:

妊娠尿检

指标类型:

主要指标 

Outcome:

Pregnancy Urine

Type:

Primary indicator 

测量时间点:

访视1

测量方法:

尿液检查

Measure time point of outcome:

Visit 1

Measure method:

Uronalysis

指标中文名:

人口统计学和基线特征

指标类型:

主要指标 

Outcome:

demographic andbaseline characteristics

Type:

Primary indicator 

测量时间点:

访视1

测量方法:

Measure time point of outcome:

Visit 1

Measure method:

指标中文名:

手指针刺血糖值

指标类型:

主要指标 

Outcome:

fingerstick glucose

Type:

Primary indicator 

测量时间点:

访视3

测量方法:

手指针刺

Measure time point of outcome:

Visit 3

Measure method:

fingerstick

指标中文名:

组织间液葡萄糖水平

指标类型:

主要指标 

Outcome:

interstitial fluid glucose levels

Type:

Primary indicator 

测量时间点:

访视3或访视4:根据随机分组情况

测量方法:

数据信息

Measure time point of outcome:

Visit 3 or 4, according to the RDC randomize

Measure method:

data information

指标中文名:

血浆葡萄糖水平

指标类型:

主要指标 

Outcome:

blood plasma glucose

Type:

Primary indicator 

测量时间点:

访视4

测量方法:

静脉血液

Measure time point of outcome:

Visit 4

Measure method:

IV blood samples

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

N/A

Sample Name:

N/A

Tissue:

N/A

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

N/A

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 75 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

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

还未开始

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

not start yet

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.受试者问卷,2.受试者日志表,3.研究病历,4.临床研究数据库CRF需求,5.门诊病历。

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

1.Subject Questionnaire,2.Patient Log,3.Worksheet,4.CRF,5.Out-patient medical records.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-25
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