The Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

NCT ID: NCT06606509

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-06-30

Brief Summary

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This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). By reviewing clinical data, physical examinations, questionnaires, continuous glucose monitoring, and subcutaneous fat ultrasound, we aim to understand the current status of treatment and metabolism in Chinese T1DM patients and analyze the potential factors that may affect their blood sugar control and metabolic indicators. A cost-effectiveness analysis will be conducted on Chinese T1DM patients using continuous glucose monitoring systems to identify the groups that benefit most from these systems.

Detailed Description

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This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). This study will collect multicenter data on T1DM patients, including sociodemographic information, anthropometric measurements, glycemic indices (glycated hemoglobin, fasting blood glucose, postprandial blood glucose), acute and chronic complications, other important metabolic indicators (blood lipids, vitamin D), insulin treatment methods, blood glucose monitoring status, diabetes education, diet and exercise, social and psychological support, and extra-pancreatic autoimmune diseases. The aims are: 1. To understand the current state of treatment and glycemic metabolism in Chinese T1DM patients and to analyze the potential factors that may affect their glycemic indices. 2. To understand the current status of continuous glucose monitoring (CGM) usage in Chinese T1DM patients and to analyze the impact of CGM on blood glucose control, acute and chronic complications, and quality of life in T1DM patients. 3. Through cost-benefit analysis, to identify potential beneficiary groups for CGM, providing objective evidence for the demand of this technology to healthcare professionals and diabetes patients; to provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.

Conditions

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Type1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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T1DM patients

Patients with Type 1 Diabetes Mellitus (T1DM) will undergo a series of examinations, including physical examinations, surveys, continuous glucose monitoring, and subcutaneous fat ultrasonography.

Continuous Glucose Monitoring System (GX-01S)

Intervention Type DEVICE

Patients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.

Interventions

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Continuous Glucose Monitoring System (GX-01S)

Patients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Volunteer to participate and be able to sign informed consent
* Patients with type 1 diabetes
* At least one of the following three clinical characteristics must be met: The disease presents initially with diabetic ketoacidosis (DKA) or ketonuria; The presence of islet-related autoantibodies, such as islet cell antibodies, tyrosine phosphatase antibodies, or glutamic acid decarboxylase (GAD) antibodies, is detected positively; Both fasting and postprandial C-peptide levels are ≤0.6 ng/mL.

Exclusion Criteria

* Other types of diabetes.
* Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianhua Ma, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Anqing Municipal Hospital

Anqing, Anhui, China

Site Status

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

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Hefei First People's Hospital

Hefei, Anhui, China

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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The First Affiliated Hospital of USTC,

Hefei, Anhui, China

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The second People's Hospital,wuhu

Wuhu, Anhui, China

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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Peking University Shenzhen Hospital

Beijing, Beijing Municipality, China

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Peking University Shougang Hospital

Beijing, Beijing Municipality, China

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Childrens Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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University-Town Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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Fujian Medical University second Affiliated Hospital

Fuzhou, Fujian, China

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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Quanzhou First Hospital.Fujian

Quanzhou, Fujian, China

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Xiamen Fifth Hospital

Xiamen, Fujian, China

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Xiamen Hospital of T.C,M.

Xiamen, Fujian, China

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Zhangshang Hospital Xiamen University

Xiamen, Fujian, China

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Gansu Provincial central Hospital

Gansu, Gansu, China

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

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Affiliated Hospital of Youjiang Medical University for Nationalities

Guangxi, Guangxi, China

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The First Affiliated Hospital of Guangxi Medical University

Guangxi, Guangxi, China

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The people's Hospital of Guangxi Zhuang Autonomous Region

Guangxi, Guangxi, China

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The Second Affiliated Hospital of Guangxi Medical University

Guangxi, Guangxi, China

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The First People's Hospital of Qinzhou

Qinzhou, Guangxi, China

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Yulin Red Cross Hospital

Yulin, Guangxi, China

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Affiliated Hospital of Guangdong Medical University

Guangdong, Guangzhou, China

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GuangZhou Eighth People 's Hospital ,GuangZhou Medical University

Guangzhou, Guangzhou, China

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The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangzhou, China

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The First Affiliated Hospital of Shantou University Medical College

Guangzhou, Guangzhou, China

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The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangzhou, China

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The Third Hospital of Guangzhou Traditional Chinese Medical University

Guangzhou, Guangzhou, China

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People'S Hospital of Anshun City Guizhou Province

Anshun, Guizhou, China

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Maternal and Child Health Hospital of Guiyang City

Guiyang, Guizhou, China

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Guiqian International General Hospital

Guizhou, Guizhou, China

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the First People'S Hospital of Zunyi

Zunyi, Guizhou, China

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The First Hospital Of Qinhuangdao

Qinhuangdao, Hebei, China

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Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

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The Second Hospital Of Hebe Medical University

Shijiazhuang, Hebei, China

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Tangshan City Workers Hospital

Tangshan, Hebei, China

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The 2nd Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

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Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

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The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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The central hospital of nanyang

Nanyang, Henan, China

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First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

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Xinxiang central hospital

Xinxiang, Henan, China

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Henan Provincial Peoples Hospital

Zhengzhou, Henan, China

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People'S Hospital of Zhengzhou

Zhengzhou, Henan, China

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The First Affiliated Hospital of Henan University of Science and Technology

Zhengzhou, Henan, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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Zhoukou central hospital

Zhoukou, Henan, China

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The central hospital of zhumadian

Zhumadian, Henan, China

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Jingmen Central Hospital

Jingmen, Hubei, China

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Jingzhou central hospital

Jingzhou, Hubei, China

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The central hospital of wuhan

Wuhan, Hubei, China

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Tongji Hospital

Wuhan, Hubei, China

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the First People'S Hospital of Lianyungang

Lianyungang, Jiangsu, China

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Jianhua Ma

Nanjing, Jiangsu, China

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Jiangsu province hospital of Chinese Medical

Nanjing, Jiangsu, China

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Affiliated hospital of nantong university

Nantong, Jiangsu, China

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The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

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Wuxi People's Hospital

Wuxi, Jiangsu, China

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

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The First Affiliated Hospital of Gannan Medical University

Gannan, Jiangxi, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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Jilin Province People's Hospital

Jilin, Jilin, China

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The First Hospital of Jilin University

Jilin, Jilin, China

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The Second Norman Bethune Hospital of Jilin University

Jilin, Jilin, China

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The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

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The People's Hospital Of Liaoning Province

Shenyang, Liaoning, China

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Affiliated Hospital of Inner Mongolia University for the Nationalities

Neimeng, Neimenggu, China

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Inner Mongolia Medical University Affiliated Hospital

Neimeng, Neimenggu, China

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Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital

Yinchuan, Ningxia, China

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The fifth People's Hospital of Qinghai Province

Qinghai, Qinghai, China

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Binzhou People's Hospital

Binzhou, Shandong, China

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Affiliated Hospital of Jining Medical University

Jining, Shandong, China

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Liaocheng People's Hospital

Liaocheng, Shandong, China

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Linyi People's Hospital

Linyi, Shandong, China

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

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People's Hospital Of Rizhao

Rizhao, Shandong, China

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Zibo Central Hospital

Zibo, Shandong, China

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Shanghai Tenth People'S Hospital

Shanghai, Shanghai Municipality, China

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Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine

Shanghai, Shanghai Municipality, China

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Baoji Central Hospital

Baoji, Shanxi, China

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Weinan Central Hospital

Weinan, Shanxi, China

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The first affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, China

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The second affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, China

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The first hospital of yulin

Yulin, Shanxi, China

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Chengdu University Affiliated Hospital

Chengdu, Sichuan, China

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Piduoqudierrenmingyiyuan

Chengdu, Sichuan, China

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People's Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, Xinjiang, China

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The First Affiliated Hospital of Shihezi University Medical School

Xinjiang, Xinjiang, China

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The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

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Urumqi First People's Hospital

Xinjiang, Xinjiang, China

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Xinjiang Construction Corps fourth division hospital

Xinjiang, Xinjiang, China

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The Fifth Affiliated Hospital of Xinjiang Medical University

Xinxiang, Xinjiang, China

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Yunnan First People's Hospital

Yunnan, Yunnan, China

Site Status

Yunnan University Affiliated Hospital

Yunnan, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Jianhua Ma, Doctor

Role: CONTACT

18951670116 ext. +8618951670116

Facility Contacts

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Daxiang Huang, Doctor

Role: primary

13955660703

Xiaolei Hu, Doctor

Role: primary

13855216339

Fang Lv, Doctor

Role: primary

15956972035

Qiu Zhang, Doctor

Role: primary

13965015060

Wei Wang, Doctor

Role: primary

13965144659

Wei Zhang, Doctor

Role: primary

13965181927

Weixin Qi, Doctor

Role: primary

15801444838

Miao Yu, Doctor

Role: primary

18601255957

Xiaofen Lian, Doctor

Role: primary

15013559903

Lan Wei, Doctor

Role: primary

15801444838

Li Li, Doctor

Role: primary

18696968656

Zhihong Wang, Doctor

Role: primary

13883021919

Gangyi Yang, Doctor

Role: primary

13637796061

Houdi Zhou, Doctor

Role: primary

13512397347

Huibin Huang, Doctor

Role: primary

13313872001

Sunjie Yan, Doctor

Role: primary

13805015737

Zhichun Sun, Doctor

Role: primary

13110959700

Jun Mi, Doctor

Role: primary

15759295993

Yi Zhou, Doctor

Role: primary

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Xiaomin Chen, Doctor

Role: primary

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Bo Sun, Doctor

Role: primary

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Jiangong Ren, Doctor

Role: primary

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Biaoliang Wu, Doctor

Role: primary

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Yingfen Qin, Doctor

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Luwen Chen, Doctor

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Yuzhen Liang, Doctor

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Pijian Yang, Doctor

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Bingna Yao, Doctor

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Juhong Yang, Doctor

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Yajuan Han, Doctor

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Chunping Zeng, Doctor

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Kun Lin, Doctor

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Ying Zhang, Doctor

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Feng Liu, Doctor

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Yu Li, Doctor

Role: primary

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Aimin Gao, Doctor

Role: primary

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Yan Zhang, Doctor

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Hongjiao Gao, Doctor

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Fuzai Yin, Doctor

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Shuchun Chen, Doctor

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Lihui Zhang, Doctor

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Hui Fang, Doctor

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Yanan Ni, Doctor

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Binhong Duan, Doctor

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Hongyu Kuang, Doctor

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Zhifeng Cheng, Doctor

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Xiaojin Zhang, Doctor

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Huijuan Yuan, Doctor

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Sensen Du, Doctor

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Donghui Yang, Doctor

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Xiaojin Zhang, Doctor

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Cuifeng Wei, Doctor

Role: primary

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Junli Xue, Doctor

Role: primary

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Zhongjing Wang, Doctor

Role: primary

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Zhelong Liu, Doctor

Role: primary

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Guofeng Wang, Doctor

Role: primary

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Xiqiao Zhou, Doctor

Role: primary

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Yunjuan Gu, Doctor

Role: primary

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Bimin Shi, Doctor

Role: primary

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Yun Hu, Doctor

Role: primary

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Houfa Geng, Doctor

Role: primary

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Shihua Hong, Doctor

Role: primary

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Jixiong Xu, Doctor

Role: primary

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Yadong Sun, Doctor

Role: primary

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Guixia Wang, Doctor

Role: primary

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Hanqing Cai, Doctor

Role: primary

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Tianshu Gao, Doctor

Role: primary

181 0245 9018

Binhong Wen, Doctor

Role: primary

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Hong Chang, Doctor

Role: primary

139 4755 0162

Wuyun Zhang, Doctor

Role: primary

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Hong Lei, Doctor

Role: primary

13909571880

Mingfu Ma, Doctor

Role: primary

13519714619

Wen Yu, Doctor

Role: primary

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Mei Zhang, Doctor

Role: primary

13515374089

Jie Bai, Doctor

Role: primary

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Qingyu Dong, Doctor

Role: primary

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Yangang Wang, Doctor

Role: primary

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Honghua Fei, Doctor

Role: primary

18806331051

Xiaodong Zhao, Doctor

Role: primary

18678186512

Haibing Chen, Doctor

Role: primary

18930173813

Shan Huang, Doctor

Role: primary

18121226290

Lifen Ma, Doctor

Role: primary

17392627866

Yingli Ma, Doctor

Role: primary

13992307005

Fengping Lei, Doctor

Role: primary

18821688160

Jing Xu, Doctor

Role: primary

13772151682

Aihua Jia, Doctor

Role: primary

18992275174

Shan Wang, Doctor

Role: primary

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Xueqin Yan, Doctor

Role: primary

136 8817 5468

Jun Li, Doctor

Role: primary

18703093580

Shen Jiang, Doctor

Role: primary

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yu wen, Doctor

Role: primary

13579868626

Jing Xu, Doctor

Role: primary

18099800011

Minzhe Wang, Doctor

Role: primary

18999858628

Yan Wang, Doctor

Role: primary

13888612322

Ying Yang, Doctor

Role: primary

13808792563

Other Identifiers

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KY20240514-10

Identifier Type: -

Identifier Source: org_study_id

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