ChiCTR2400088927 版本V1.1 版本创建时间2024/08/29 10:26:35 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400088927 

最近更新日期：

Date of Last Refreshed on：

 2024-08-29 10:26:24 

注册时间：

Date of Registration：

 2024-08-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

“双C”方案对妊娠期糖尿病血糖控制及妊娠结局观察

Public title：

"Double C" plan for blood glucose control and pregnancy outcome of gestational diabetes observe

注册题目简写：

“双C”方案对妊娠期糖尿病血糖控制及妊娠结局观察

English Acronym：

"Double C" plan for blood glucose control and pregnancy outcome of gestational diabetes observe

研究课题的正式科学名称：

“双C”方案对妊娠期糖尿病血糖控制及妊娠结局观察

Scientific title：

"Double C" plan for blood glucose control and pregnancy outcome of gestational diabetes observe

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：

石喜玲 

研究负责人：

石喜玲 

Applicant：

shixili 

Study leader：

shixiling 

申请注册联系人电话：

Applicant telephone：

 +86 158 7068 6037

研究负责人电话：

Study leader's
telephone：

+86 158 7068 6037

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：

 shixilingnd@126.com

研究负责人电子邮件：

Study leader's E-mail：

 shixilingnd@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 江西省妇幼保健院

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 暂无

申请注册联系人通讯地址：

江西省南昌市红谷新区西站大街508号

研究负责人通讯地址：

江西省南昌市红谷新区西站大街508号

Applicant address：

No. 508, West Station Street, Honggu New District, Nanchang City, Jiangxi Province

Study leader's address：

No. 508, West Station Street, Honggu New District, Nanchang City, Jiangxi Province

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：

江西省妇幼保健院

Applicant's institution：

Jiangxi Maternal and Child Health Hospital

研究负责人所在单位：

江西省妇幼保健院

Affiliation of the Leader：

Jiangxi Maternal and Child Health Hospital

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：

 EC-KY-202369

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：

江西省妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Jiangxi Maternal and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-09-13 00:00:00

伦理委员会联系人：

李方元

Contact Name of the ethic committee：

Li Fangyuan

伦理委员会联系地址：

江西省南昌市红谷新区西站大街508号

Contact Address of the ethic committee：

No. 508, West Station Street, Honggu New District, Nanchang City, Jiangxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 187 7009 1221

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 jxfbec@163.com

研究实施负责（组长）单位：

江西省妇幼保健院

Primary sponsor：

Jiangxi Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

江西省南昌市红谷新区西站大街508号

Primary sponsor's address：

No. 508, West Station Street, Honggu New District, Nanchang City, Jiangxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江西

市(区县)：

南昌

Country：

China

Province：

jiangxi

City：

nanchang

单位(医院)：

江西省妇幼保健院

具体地址：

江西省南昌市红谷滩新区西站大街508号

Institution
hospital：

Jiangxi Maternal and Child Health Hospital

Address：

No. 508, West Station Street, Honggu New District, Nanchang City, Jiangxi Province

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

妊娠期糖尿病  

Target disease：

gestational diabetes mellitus

研究疾病代码：

024

Target disease code：

024

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本课题拟通过对GDM患者进行 “双C”方案治疗，比较其和常规血糖监测和胰岛素注射治疗的GDM患者在治疗前、治疗1月后患者空腹血糖（FBG）、餐后2h血糖（PBG）、睡前血糖及糖化血红蛋白水平（HbA1c）等指标变化，观察不良妊娠结局发生情况，包含妊娠期高血压、羊水过多、剖宫产、低血糖、胎膜早破、产后出血等发生率。观察新生儿并发症发生情况，包含早产、胎儿窘迫、巨大儿、新生儿窒息等。从而为改善GDM的治疗效果，降低GDM对患者和新生儿并发症的发生率提供临床证据。  

Objectives of Study：

This study intends to compare the changes of fasting blood glucose (FBG), 2h postprandial blood glucose (PBG), blood glucose before and after 1 month of treatment with GDM patients treated with routine blood glucose monitoring and insulin injection through the "double C" regimen. To observe the incidence of adverse pregnancy outcomes, including pregnancy-induced hypertension, hyperamniotic fluid, cesarean section, hypoglycemia, premature rupture of membranes, and postpartum hemorrhage. Neonatal complications were observed, including premature delivery, fetal distress, macrosomia, neonatal asphyxia, etc. It provides clinical evidence for improving the therapeutic effect of GDM and reducing the incidence of complications of GDM in patients and neonates.

药物成份或治疗方案详述：

诺和锐(Penfill No. S20153001)  

Description for medicine or protocol of treatment in detail：

NovoRapid (Penfill No. S20153001)  

纳入标准：

（１）均行饮食指导+适当运动后血糖控制不佳，住院接受胰岛素泵强化治疗者；（２）本研究经本院医学伦理委员会审批，所有患者均了解本研究基本事项，自愿参加并签署书面知情同意书；（３）依从性较好。

Inclusion criteria

(1) Patients with poor blood sugar control after diet guidance and appropriate exercise were hospitalized to receive intensive insulin pump therapy; (2) This study was approved by the Medical Ethics Committee of our hospital, and all patients understood the basic matters of this study, voluntarily participated in it and signed written informed consent; (3) Good compliance.

排除标准：

贫血患者；孕前糖尿病患者；糖尿病遗传史患者；肝肾功能异常患者；存在沟通或交流障碍者；胰岛素过敏反应患者；慢性感染性疾病患者；妊娠前及妊娠期间均未曾服用对机体糖代谢有影响的药物或保健品。

Exclusion criteria：

Patients with anemia; Diabetic patients before pregnancy; Patients with a genetic history of diabetes; Patients with abnormal liver and kidney function; People with communication or communication difficulties; Patients with insulin allergic reaction; Patients with chronic infectious diseases; Before and during pregnancy, no drugs or health products have been taken that have an impact on the body's sugar metabolism.

研究实施时间：

Study execute time：

从 From 2021-01-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-26 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

胰岛素注射组

样本量：

 60

Group：

Insulin injection group

Sample size：

干预措施：

通过皮下注射速效胰岛素进行血糖控制，包括NovoRapid (FlexPen NO.S20217021)和Levemir (FlexPen NO.S20217014)。方案为:餐前5min皮下给予NovoRapid 0.2 ~ 0.3 u /(kg-d)，睡前给予Levemir 0.1 ~ 0.3 u /(kg-d)。每天在7个特定时间用血糖仪监测血糖(饭前3次，饭后2小时3次，睡前1次)。根据FBG和PBG值调整基础剂量，根据餐后2小时的血糖水平和餐后值调整餐前胰岛素剂量。 观察指标：治疗前、治疗2周后患者空腹血糖（FBG）、餐后2h血糖（PBG）、睡前血糖等血糖指标变化，妊娠期高血压疾病、羊水过多、低血糖、胎膜早破、产后出血等，早产、胎儿窘迫、巨大儿、新生儿窒息等。

干预措施代码：

Intervention：

Blood glucose management was accomplished with subcutaneous injections of rapid-acting insulin, including NovoRapid (FlexPen NO.S20217021) and Levemir (FlexPen NO.S20217014). The regimen was: NovoRapid at 0.2-0.3U/(kg-d) was administered subcutaneously 5 min before each meal, and Levemir at 0.1-0.3U/(kg-d) at bedtime. Blood glucose was monitored daily at seven specific times using a glucometer (three times before meals, three times 2 hours after meals, and once at bedtime). Adjustments were made to the basal dose based on FBG and PBG values, and the preprandial insulin dose was adjusted based on glucose levels 2 h after a meal and postprandial values. Outcome measures: Changes of fasting blood glucose (FBG), 2h postpranational blood glucose (PBG), blood glucose before and after 2 weeks of treatment, hypertensive diseases during pregnancy, hyperamniotic fluid, hypoglycemia, premature rupture of membranes, postpartum hemorrhage, premature delivery, fetal distress, macrosomia, neonatal asphyxia, etc.

Intervention code：

组别：

双“C”方案组

样本量：

 60

Group：

Double "C" group

Sample size：

干预措施：

使用胰岛素泵（Model: TruCare II）给药。方案为:连续皮下输注0.4 ~ 0.5 U/(kg-d)的NovoRapid(Penfill No. S20153001) 。基础剂量为每日总剂量的一半，餐前丸为每日总剂量的一半，每次餐前5分钟给药。每天监测血糖(与MDI组一样)，并根据每日血糖波动和第二天餐前水平调整胰岛素剂量。 观察指标：治疗前、治疗2周后患者空腹血糖（FBG）、餐后2h血糖（PBG）、睡前血糖等血糖指标变化，妊娠期高血压疾病、羊水过多、低血糖、胎膜早破、产后出血等，早产、胎儿窘迫、巨大儿、新生儿窒息等。

干预措施代码：

Intervention：

An insulin pump (Model: TruCare II) was used for NovoRapid (Penfill No. S20153001) administration. The regimen was: a continuous infusion of NovoRapid at 0.4-0.5 U/(kg-d) was delivered subcutaneously. The basal dose was half the total daily dose, and a pre-meal bolus was half the total daily dose, administered 5 min before each meal. Blood glucose was monitored daily (as in the MDI group), and insulin doses were adjusted based on daily glucose fluctuations and pre-meal levels the following day. Outcome measures: Changes of fasting blood glucose (FBG), 2h postpranational blood glucose (PBG), blood glucose before and after 2 weeks of treatment, hypertensive diseases during pregnancy, hyperamniotic fluid, hypoglycemia, premature rupture of membranes, postpartum hemorrhage, premature delivery, fetal distress, macrosomia, neonatal asphyxia, etc.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

 南昌 

Country：

China

Province：

jiangxi

City：

nanchang

单位(医院)：

 江西省妇幼保健院 

单位级别：

 三甲 

Institution
hospital：

Jiangxi Maternal and Child Health Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血糖

指标类型：

主要指标

Outcome：

FBG

Type：

Primary indicator

测量时间点：

治疗前后一个月

测量方法：

末梢血

Measure time point of outcome：

One month before and after treatment

Measure method：

Peripheral blood

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destroy after use

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 18 岁 years
最大 Max age 45 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）：

抽签随机分组法

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

Lottery random grouping method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

日期填写时间2024.8.6；ResMan管理平台:http://www.medresman.org.cn/login.aspx

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

date:2024.8.6;ResMan:http://www.medresman.org.cn/login.aspx

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、病例记录表 (Case Record Form, CRF)： 设计与内容： CRF包含患者的基本信息、治疗记录、随访数据等必要的临床数据项。 数据收集与填写： 研究人员将在患者每次就诊时填写CRF，确保数据的及时性和准确性。 2、电子数据采集和管理系统 (Electronic Data Capture, EDC)： 本研究将使用ResMan电子数据采集和管理系统（http://www.medresman.org.cn/login.aspx）注册账号：sxl19861122,管理员：石喜玲。 数据录入与存储： 所有CRF数据在结束后转录到ResMan系统中。 数据管理与安全： ResMan系统提供严格的访问控制和数据加密存储，确保数据安全。 数据共享与访问： 研究数据将在研究结束后适时公开，授权的研究人员可以通过ResMan系统申请访问。

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

1. Case Record Form (CRF) : Design and Content: CRF contains basic patient information, treatment records, follow-up data and other necessary clinical data items. Data collection and filling: Researchers will fill out the CRF at each patient visit, ensuring the timeliness and accuracy of the data. 2, Electronic Data Capture and management system (EDC) : This study will use the ResMan electronic data collection and management system (http://www.medresman.org.cn/login.aspx) registered account sxl19861122, administrator Shi Xiling. Data entry and storage: All CRF data is transcribed into the ResMan system after completion. Data Management and Security: ResMan systems provide strict access control and encrypted data storage to ensure data security. Data sharing and access: The study data will be publicly available at the end of the study, and authorized researchers can request access through the ResMan system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-08-29 10:26:18