Chinese Clinical Trial Register (ChiCTR) - The world health organization international clinical trials registered organization registered platform

注册号： Registration number：	ChiCTR-OPC-15006147
最近更新日期： Date of Last Refreshed on：	2015-03-28
注册时间： Date of Registration：	2015-03-25
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：
Public title：	A Multicenter Clinical Accuracy Evaluation of the Abbott Sensor Based Interstitial Glucose Monitoring System in Chinese Diabetes Subjects
注册题目简写：
English Acronym：
研究课题的正式科学名称：
Scientific title：	Clinical Accuracy Evaluation of the Abbott Sensor Based Interstitial Glucose Monitoring System
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：		研究负责人：
Applicant：	Jolyon Bugler	Study leader：	Professor Linong Ji
申请注册联系人电话： Applicant telephone：	+44 1993 863164	研究负责人电话： Study leader's telephone：	+86 10-88324516-3210
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：	joe.bugler@abbott.com	研究负责人电子邮件： Study leader's E-mail：	jilinong@gmail.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：		研究负责人通讯地址：
Applicant address：	Range Road, Witney, United Kingdom	Study leader's address：	Peking University People's Hospital, No.11 Xizhimen south street, Xicheng District, Beijing
申请注册联系人邮政编码： Applicant postcode：	OX29 0YL	研究负责人邮政编码： Study leader's postcode：
申请人所在单位：
Applicant's institution：	Abbott Diabetes Care

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：	2014PHA051-01	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：
Name of the ethic committee：	Medical Ethics Committee of Peking University People’s Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2015-01-21
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
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：
Primary sponsor：	Abbott Diabetes Care
研究实施负责（组长）单位地址：
Primary sponsor's address：	Range Road, Witney, OX29 0YL, United Kingdom
试验主办单位(项目批准或申办者)： Secondary sponsor：
经费或物资来源：
Source(s) of funding：	Abbott Diabetes Care
研究疾病：
Target disease：	Diabetes Mellitus
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：	IV期临床试验
Study phase：	4
研究目的：
Objectives of Study：	Primary Objective: -To demonstrate point accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System results (SG) against capillary Blood Glucose (BG) reference using the Consensus Error Grid. Secondary Objective: -To demonstrate point accuracy using other measures (e.g. Clarke Error Grid, difference measures). -To demonstrate trend accuracy incorporating Continuous Glucose Error Grid Analysis (CG-EGA) and rate deviation. -To evaluate the overall usability of the Abbott Sensor Based Glucose Monitoring System over a masked 14 days wear period. Safety Objective: -To evaluate the adverse events (AEs), application site signs and symptoms of the Abbott Sensor Based Glucose Monitoring System over a masked 14 days wear period and training period.
药物成份或治疗方案详述：
Description for medicine or protocol of treatment in detail：
研究设计：	队列研究
Study design：	Cohort study
纳入标准：
Inclusion criteria	1. Subject must be at least 18 years of age. 2. Subject must have type 1 or type 2 diabetes prior to enrollment. 3. Subject must require insulin therapy through an insulin pump and/or single or multiple daily insulin injections which were first started at least 6 months prior to enrollment and will be ongoing during the study. 4. Subject must be able to read and understand Chinese. 5. In the investigator’s opinion, the Subject must be able to follow the instructions provided to him/her by study site and perform all study tasks as specified by the protocol. 6. Subject must be available to participate in all study visits. 7. Subject must be willing and able to provide written signed and dated informed consent.
排除标准：
Exclusion criteria：	1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only). 3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. 4. Subject currently is participating in another clinical trial. 5. Subject has donated blood in 3 months prior to the beginning of the study activities. 6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to: ? History of Human Immunodeficiency Virus (HIV), Hepatitis B or C, or other blood-borne pathogen; ? History of abnormal hematocrit, platelet and hemoglobin within two months. ? History of anemia. 7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding (such as coagulation disorder). 8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends. 9. Subject is unsuitable for participation due to any other cause as determined by the investigator.

研究实施时间：

Study execute time：

从From2015-03-30至To

征募观察对象时间：

Recruiting time：

从From2015-04-01至To

干预措施：

Interventions：

组别：		样本量：	40
Group：	Evaluation	Sample size：	40
干预措施：		干预措施代码：
Intervention：	Accuracy of Device	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：		省(直辖市)：		市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：		单位级别：
Institution hospital：	Peking University People's Hospital	Level of the institution：	Tertiary A Hospital

国家：		省(直辖市)：		市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：		单位级别：
Institution hospital：	Peking University First Hospital	Level of the institution：	Tertiary A Hospital

国家：		省(直辖市)：		市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：		单位级别：
Institution hospital：	Beijing Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：		指标类型：	主要指标
Outcome：	Accuracy using Consensus Error Grid	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：		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	18	岁 years
最大 Max age		岁 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）：

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

NA

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results ater the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	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）：
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：
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：
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
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：	2015-03-25