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

The Chinese Clinical Research Plan for the Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

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.

Study Overview

Status

Not yet recruiting

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Anhui
      • Anqing, Anhui, China
        • Anqing Municipal Hospital
        • Contact:
          • Daxiang Huang, Doctor
          • Phone Number: 13955660703
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
          • Xiaolei Hu, Doctor
          • Phone Number: 13855216339
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Qiu Zhang, Doctor
          • Phone Number: 13965015060
      • Hefei, Anhui, China
        • Hefei First People's Hospital
        • Contact:
          • Fang Lv, Doctor
          • Phone Number: 15956972035
      • Hefei, Anhui, China
        • The First Affiliated Hospital of USTC,
        • Contact:
          • Wei Wang, Doctor
          • Phone Number: 13965144659
      • Wuhu, Anhui, China
        • The second People's Hospital,wuhu
        • Contact:
          • Wei Zhang, Doctor
          • Phone Number: 13965181927
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
        • Contact:
          • Miao Yu, Doctor
          • Phone Number: 18601255957
      • Beijing, Beijing, China
        • China-Japan Friendship Hospital
        • Contact:
          • Weixin Qi, Doctor
          • Phone Number: 15801444838
      • Beijing, Beijing, China
        • Peking University Shougang Hospital
        • Contact:
          • Lan Wei, Doctor
          • Phone Number: 15801444838
      • Beijing, Beijing, China
        • Peking University Shenzhen Hospital
        • Contact:
          • Xiaofen Lian, Doctor
          • Phone Number: 15013559903
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Zhihong Wang, Doctor
          • Phone Number: 13883021919
      • Chongqing, Chongqing, China
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Gangyi Yang, Doctor
          • Phone Number: 13637796061
      • Chongqing, Chongqing, China
        • Childrens Hospital of Chongqing Medical University
        • Contact:
          • Li Li, Doctor
          • Phone Number: 18696968656
      • Chongqing, Chongqing, China
        • University-Town Hospital of Chongqing Medical University
        • Contact:
          • Houdi Zhou, Doctor
          • Phone Number: 13512397347
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Sunjie Yan, Doctor
          • Phone Number: 13805015737
      • Fuzhou, Fujian, China
        • Fujian Medical University second Affiliated Hospital
        • Contact:
          • Huibin Huang, Doctor
          • Phone Number: 13313872001
      • Quanzhou, Fujian, China
        • Quanzhou First Hospital.Fujian
        • Contact:
          • Zhichun Sun, Doctor
          • Phone Number: 13110959700
      • Xiamen, Fujian, China
        • Xiamen Fifth Hospital
        • Contact:
          • Jun Mi, Doctor
          • Phone Number: 15759295993
      • Xiamen, Fujian, China
        • Xiamen Hospital of T.C,M.
        • Contact:
          • Yi Zhou, Doctor
          • Phone Number: 13720899619
      • Xiamen, Fujian, China
        • Zhangshang Hospital Xiamen University
        • Contact:
          • Xiaomin Chen, Doctor
          • Phone Number: 13860487599
    • Gansu
      • Gansu, Gansu, China
        • Gansu Provincial central Hospital
        • Contact:
          • Bo Sun, Doctor
          • Phone Number: 13369310895
      • Lanzhou, Gansu, China
        • Lanzhou University Second Hospital
        • Contact:
          • Jiangong Ren, Doctor
          • Phone Number: 13099158878
    • Guangxi
      • Guangxi, Guangxi, China
        • Affiliated Hospital of Youjiang Medical University for Nationalities
        • Contact:
          • Biaoliang Wu, Doctor
          • Phone Number: 13977621889
      • Guangxi, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Yingfen Qin, Doctor
          • Phone Number: 13607862619
      • Guangxi, Guangxi, China
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • Luwen Chen, Doctor
          • Phone Number: 18677181430
      • Guangxi, Guangxi, China
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Yuzhen Liang, Doctor
          • Phone Number: 13517665676
      • Qinzhou, Guangxi, China
        • The First People's Hospital of Qinzhou
        • Contact:
          • Pijian Yang, Doctor
          • Phone Number: 13471719878
      • Yulin, Guangxi, China
        • Yulin Red Cross Hospital
        • Contact:
          • Bingna Yao, Doctor
          • Phone Number: 15977068193
    • Guangzhou
      • Guangdong, Guangzhou, China
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Juhong Yang, Doctor
          • Phone Number: 13821024560
      • Guangzhou, Guangzhou, China
        • GuangZhou Eighth People 's Hospital ,GuangZhou Medical University
        • Contact:
          • Yajuan Han, Doctor
          • Phone Number: 13763393673
      • Guangzhou, Guangzhou, China
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Chunping Zeng, Doctor
          • Phone Number: 13500260675
      • Guangzhou, Guangzhou, China
        • The First Affiliated Hospital of Shantou University Medical College
        • Contact:
          • Kun Lin, Doctor
          • Phone Number: 13556422916
      • Guangzhou, Guangzhou, China
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Ying Zhang, Doctor
          • Phone Number: 13556001042
      • Guangzhou, Guangzhou, China
        • The Third Hospital of Guangzhou Traditional Chinese Medical University
        • Contact:
          • Feng Liu, Doctor
          • Phone Number: 15989185374
    • Guizhou
      • Anshun, Guizhou, China
        • People'S Hospital of Anshun City Guizhou Province
        • Contact:
          • Yu Li, Doctor
          • Phone Number: 15338536945
      • Guiyang, Guizhou, China
        • Maternal and Child Health Hospital of Guiyang City
        • Contact:
          • Aimin Gao, Doctor
          • Phone Number: 13985467171
      • Guizhou, Guizhou, China
        • Guiqian International General Hospital
        • Contact:
          • Yan Zhang, Doctor
          • Phone Number: 18685018424
      • Zunyi, Guizhou, China
        • The First People'S Hospital of Zunyi
        • Contact:
          • Hongjiao Gao, Doctor
          • Phone Number: 13984910556
    • Hebei
      • Qinhuangdao, Hebei, China
        • The First Hospital of Qinhuangdao
        • Contact:
          • Fuzai Yin, Doctor
          • Phone Number: 13633355511
      • Shijia Zhuang, Hebei, China
        • Hebei Provincial People's Hospital
        • Contact:
          • Shuchun Chen, Doctor
          • Phone Number: 13833166283
      • Shijia Zhuang, Hebei, China
        • The Second Hospital Of Hebe Medical University
        • Contact:
          • Lihui Zhang, Doctor
          • Phone Number: 15803210962
      • Tangshan, Hebei, China
        • Tangshan City Workers Hospital
        • Contact:
          • Hui Fang, Doctor
          • Phone Number: 13831581838
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
          • Zhifeng Cheng, Doctor
          • Phone Number: 18903602198
      • Ha'erbin, Heilongjiang, China
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Hongyu Kuang, Doctor
          • Phone Number: 13339300885
      • Ha'erbin, Heilongjiang, China
        • Heilongjiang Provincial Hospital
        • Contact:
          • Binhong Duan, Doctor
          • Phone Number: 13796663517
      • Haerbin, Heilongjiang, China
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:
          • Yanan Ni, Doctor
          • Phone Number: 13644501246
    • Henan
      • Nanyang, Henan, China
        • The central hospital of nanyang
        • Contact:
          • Xiaojin Zhang, Doctor
          • Phone Number: 13673371024
      • Xinxiang, Henan, China
        • Xinxiang Central Hospital
      • Xinxiang, Henan, China
        • First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China
        • the First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
        • Henan Provincial Peoples Hospital
        • Contact:
          • Huijuan Yuan, Doctor
          • Phone Number: 13513891997
      • Zhengzhou, Henan, China
        • People's Hospital of Zhengzhou
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Sensen Du, Doctor
          • Phone Number: 18903886605
      • Zhoukou, Henan, China
        • Zhoukou Central Hospital
        • Contact:
          • Donghui Yang, Doctor
          • Phone Number: 13938059080
      • Zhumadian, Henan, China
        • The central hospital of zhumadian
        • Contact:
          • Xiaojin Zhang, Doctor
          • Phone Number: 13673371024
    • Hubei
      • Jingmen, Hubei, China
        • Jingmen Central Hospital
        • Contact:
          • Cuifeng Wei, Doctor
          • Phone Number: 13971830674
      • Jingzhou, Hubei, China
        • Jingzhou Central Hospital
        • Contact:
          • Junli Xue, Doctor
          • Phone Number: 18972160273
      • Wuhan, Hubei, China
        • The Central Hospital of Wuhan
        • Contact:
          • Zhongjing Wang, Doctor
          • Phone Number: 13007111056
      • Wuhan, Hubei, China
        • Tongji Hospital
        • Contact:
          • Zhelong Liu, Doctor
          • Phone Number: 13986235028
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • The First People's Hospital of Lianyungang
        • Contact:
          • Guofeng Wang, Doctor
          • Phone Number: 189 6132 7083
      • Nanjing, Jiangsu, China, 210006
        • Jianhua Ma
      • Nanjing, Jiangsu, China
        • Jiangsu province hospital of Chinese Medical
        • Contact:
          • Xiqiao Zhou, Doctor
          • Phone Number: 13951826318
      • Nantong, Jiangsu, China
        • Affiliated Hospital of Nantong University
        • Contact:
          • Yunjuan Gu, Doctor
          • Phone Number: 15851207860
      • Suzhou, Jiangsu, China
        • the First Affiliated Hospital of Soochow University
        • Contact:
          • Bimin Shi, Doctor
          • Phone Number: 138 6256 9825
      • Wuxi, Jiangsu, China
        • Wuxi People's Hospital
        • Contact:
          • Yun Hu, Doctor
          • Phone Number: 189 5167 0359
      • Xuzhou, Jiangsu, China
        • Xuzhou Central Hospital
        • Contact:
          • Houfa Geng, Doctor
          • Phone Number: 180 6871 8580
    • Jiangxi
      • Gannan, Jiangxi, China
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Shihua Hong, Doctor
          • Phone Number: 13576709593
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Jixiong Xu, Doctor
          • Phone Number: 13307086069
    • Jilin
      • Jilin, Jilin, China
        • The First Hospital of Jilin University
        • Contact:
          • Guixia Wang, Doctor
          • Phone Number: 15843081103
      • Jilin, Jilin, China
        • Jilin Province People's Hospital
        • Contact:
          • Yadong Sun, Doctor
          • Phone Number: 15843076585
      • Jilin, Jilin, China
        • The Second Norman Bethune Hospital of Jilin University
        • Contact:
          • Hanqing Cai, Doctor
          • Phone Number: 13674315020
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
        • Contact:
          • Tianshu Gao, Doctor
          • Phone Number: 181 0245 9018
      • Shenyang, Liaoning, China
        • The People's Hospital of Liaoning Province
        • Contact:
          • Binhong Wen, Doctor
          • Phone Number: 13604925258
    • Ningxia
      • Yinchuan, Ningxia, China, 20817
        • Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital
        • Contact:
          • Hong Lei, Doctor
          • Phone Number: 13909571880
    • Qinghai
      • Qinghai, Qinghai, China
        • The Fifth People's Hospital of Qinghai Province
        • Contact:
          • Mingfu Ma, Doctor
          • Phone Number: 13519714619
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou People's Hospital
        • Contact:
          • Wen Yu, Doctor
          • Phone Number: 18554301318
      • Jining, Shandong, China
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Mei Zhang, Doctor
          • Phone Number: 13515374089
      • Liaocheng, Shandong, China
        • Liaocheng People's Hospital
        • Contact:
          • Jie Bai, Doctor
          • Phone Number: 13346258761
      • Linyi, Shandong, China
        • Linyi people's hospital
        • Contact:
          • Qingyu Dong, Doctor
          • Phone Number: 15092889280
      • Qingdao, Shandong, China
        • The affiliated hospital of Qingdao university
        • Contact:
          • Yangang Wang, Doctor
          • Phone Number: 18661807293
      • Rizhao, Shandong, China
        • People's Hospital of Rizhao
        • Contact:
          • Honghua Fei, Doctor
          • Phone Number: 18806331051
      • Zibo, Shandong, China
        • Zibo Central Hospital
        • Contact:
          • Xiaodong Zhao, Doctor
          • Phone Number: 18678186512
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Tenth People's Hospital
        • Contact:
          • Haibing Chen, Doctor
          • Phone Number: 18930173813
      • Shanghai, Shanghai, China
        • Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine
        • Contact:
          • Shan Huang, Doctor
          • Phone Number: 18121226290
    • Shanxi
      • Baoji, Shanxi, China
        • Baoji Central Hospital
        • Contact:
          • Lifen Ma, Doctor
          • Phone Number: 17392627866
      • Weinan, Shanxi, China
        • Weinan Central Hospital
        • Contact:
          • Yingli Ma, Doctor
          • Phone Number: 13992307005
      • Xi'an, Shanxi, China
        • The First Affiliated Hospital Of Xi'an Jiaotong University
        • Contact:
          • Fengping Lei, Doctor
          • Phone Number: 18821688160
      • Xi'an, Shanxi, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jing Xu, Doctor
          • Phone Number: 13772151682
      • Yulin, Shanxi, China
        • The first hospital of yulin
        • Contact:
          • Aihua Jia, Doctor
          • Phone Number: 18992275174
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu University Affiliated Hospital
        • Contact:
          • Shan Wang, Doctor
          • Phone Number: 18140151533
      • Chengdu, Sichuan, China
        • Piduoqudierrenmingyiyuan
        • Contact:
          • Xueqin Yan, Doctor
          • Phone Number: 136 8817 5468
    • Xinjiang
      • Xinjiang, Xinjiang, China
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Xinjiang, Xinjiang, China
        • The First Affiliated Hospital of Shihezi University Medical School
        • Contact:
          • Jun Li, Doctor
          • Phone Number: 18703093580
      • Xinjiang, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Shen Jiang, Doctor
          • Phone Number: 18999936571
      • Xinjiang, Xinjiang, China
        • Urumqi First People's Hospital
        • Contact:
          • yu wen, Doctor
          • Phone Number: 13579868626
      • Xinjiang, Xinjiang, China
        • Xinjiang Construction Corps fourth division hospital
        • Contact:
          • Jing Xu, Doctor
          • Phone Number: 18099800011
      • Xinxiang, Xinjiang, China
        • The Fifth Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Minzhe Wang, Doctor
          • Phone Number: 18999858628
    • Yunnan
      • Yunnan, Yunnan, China
        • Yunnan First People's Hospital
        • Contact:
          • Yan Wang, Doctor
          • Phone Number: 13888612322
      • Yunnan, Yunnan, China
        • Yunnan University Affiliated Hospital
        • Contact:
          • Ying Yang, Doctor
          • Phone Number: 13808792563
    • neimenggu
      • Neimeng, neimenggu, China
        • Affiliated Hospital of Inner Mongolia University for the Nationalities
        • Contact:
          • Hong Chang, Doctor
          • Phone Number: 139 4755 0162
      • Neimeng, neimenggu, China
        • Inner Mongolia Medical University Affiliated Hospital
        • Contact:
          • Wuyun Zhang, Doctor
          • Phone Number: 15848378806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study aims to recruit 1,000 patients with Type 1 Diabetes Mellitus (T1DM) from endocrinology departments across various centers between June 2024 and June 2025, both inpatient and outpatient.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current status of blood sugar control in Chinese patients with type 1 diabetes
Time Frame: 3 years
Using continuous glucose monitoring systems to understand the current status of blood sugar control in Chinese patients with type 1 diabetes; analyzing the possible factors that may affect the glycometabolic indicators of Chinese patients with type 1 diabetes.
3 years
Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes
Time Frame: 3 years
Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes, and analyze its impact on blood sugar control, acute and chronic complications, and quality of life for patients with type 1 diabetes
3 years
Potential beneficiary groups of continuous glucose monitoring
Time Frame: 3 years
Through cost-effectiveness analysis, identify the potential beneficiary groups of continuous glucose monitoring to provide objective evidence for the demand for this technology by healthcare professionals and diabetes patients; provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current treatment status of Chinese patients with type 1 diabetes
Time Frame: 3 years
Gain a multi-dimensional understanding of the current treatment status of Chinese patients with type 1 diabetes, including aspects such as blood glucose monitoring, education, drug treatment, nutrition, and social support.
3 years
Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
Time Frame: 3 years
Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jianhua Ma, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 7, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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