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).
1 other identifier
observational
1,000
1 country
101
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Typical duration for all trials
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
September 23, 2024
August 1, 2024
2 years
August 26, 2024
September 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Current status of blood sugar control in Chinese patients with type 1 diabetes
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
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
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 Outcomes (2)
Current treatment status of Chinese patients with type 1 diabetes
3 years
Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
3 years
Study Arms (1)
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.
Interventions
Patients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Other types of diabetes.
- Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Anqing Municipal Hospital
Anqing, Anhui, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Hefei First People's Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC,
Hefei, Anhui, China
The second People's Hospital,wuhu
Wuhu, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Shenzhen Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University second Affiliated Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Quanzhou First Hospital.Fujian
Quanzhou, Fujian, China
Xiamen Fifth Hospital
Xiamen, Fujian, China
Xiamen Hospital of T.C,M.
Xiamen, Fujian, China
Zhangshang Hospital Xiamen University
Xiamen, Fujian, China
Gansu Provincial central Hospital
Gansu, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Affiliated Hospital of Youjiang Medical University for Nationalities
Guangxi, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Guangxi, Guangxi, China
The people's Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, China
The Second Affiliated Hospital of Guangxi Medical University
Guangxi, Guangxi, China
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, China
Yulin Red Cross Hospital
Yulin, Guangxi, China
Affiliated Hospital of Guangdong Medical University
Guangdong, Guangzhou, China
GuangZhou Eighth People 's Hospital ,GuangZhou Medical University
Guangzhou, Guangzhou, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
The First Affiliated Hospital of Shantou University Medical College
Guangzhou, Guangzhou, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
The Third Hospital of Guangzhou Traditional Chinese Medical University
Guangzhou, Guangzhou, China
People'S Hospital of Anshun City Guizhou Province
Anshun, Guizhou, China
Maternal and Child Health Hospital of Guiyang City
Guiyang, Guizhou, China
Guiqian International General Hospital
Guizhou, Guizhou, China
the First People'S Hospital of Zunyi
Zunyi, Guizhou, China
The First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
The Second Hospital Of Hebe Medical University
Shijiazhuang, Hebei, China
Tangshan City Workers Hospital
Tangshan, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The central hospital of nanyang
Nanyang, Henan, China
First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang central hospital
Xinxiang, Henan, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China
People'S Hospital of Zhengzhou
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhoukou central hospital
Zhoukou, Henan, China
The central hospital of zhumadian
Zhumadian, Henan, China
Jingmen Central Hospital
Jingmen, Hubei, China
Jingzhou central hospital
Jingzhou, Hubei, China
The central hospital of wuhan
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
the First People'S Hospital of Lianyungang
Lianyungang, Jiangsu, China
Jianhua Ma
Nanjing, Jiangsu, 210006, China
Jiangsu province hospital of Chinese Medical
Nanjing, Jiangsu, China
Affiliated hospital of nantong university
Nantong, Jiangsu, China
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Province People's Hospital
Jilin, Jilin, China
The First Hospital of Jilin University
Jilin, Jilin, China
The Second Norman Bethune Hospital of Jilin University
Jilin, Jilin, China
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China
Affiliated Hospital of Inner Mongolia University for the Nationalities
Neimeng, Neimenggu, China
Inner Mongolia Medical University Affiliated Hospital
Neimeng, Neimenggu, China
Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital
Yinchuan, Ningxia, 20817, China
The fifth People's Hospital of Qinghai Province
Qinghai, Qinghai, China
Binzhou People's Hospital
Binzhou, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
People's Hospital Of Rizhao
Rizhao, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Shanghai Tenth People'S Hospital
Shanghai, Shanghai Municipality, China
Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine
Shanghai, Shanghai Municipality, China
Baoji Central Hospital
Baoji, Shanxi, China
Weinan Central Hospital
Weinan, Shanxi, China
The first affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, China
The second affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, China
The first hospital of yulin
Yulin, Shanxi, China
Chengdu University Affiliated Hospital
Chengdu, Sichuan, China
Piduoqudierrenmingyiyuan
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, Xinjiang, China
The First Affiliated Hospital of Shihezi University Medical School
Xinjiang, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
Urumqi First People's Hospital
Xinjiang, Xinjiang, China
Xinjiang Construction Corps fourth division hospital
Xinjiang, Xinjiang, China
The Fifth Affiliated Hospital of Xinjiang Medical University
Xinxiang, Xinjiang, China
Yunnan First People's Hospital
Yunnan, Yunnan, China
Yunnan University Affiliated Hospital
Yunnan, Yunnan, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianhua Ma, Doctor
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2024
First Posted
September 23, 2024
Study Start
November 7, 2024
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
September 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share