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

Not yet recruiting
Conditions
Type1 Diabetes Mellitus
Interventions
Device: Continuous Glucose Monitoring System (GX-01S)
Registration Number
NCT06606509
Lead Sponsor
Nanjing First Hospital, Nanjing Medical University
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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
T1DM patientsContinuous Glucose Monitoring System (GX-01S)Patients with Type 1 Diabetes Mellitus (T1DM) will undergo a series of examinations, including physical examinations, surveys, continuous glucose monitoring, and subcutaneous fat ultrasonography.
Primary Outcome Measures
NameTimeMethod
Current status of blood sugar control in Chinese patients with type 1 diabetes3 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.

Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes3 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

Potential beneficiary groups of continuous glucose monitoring3 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.

Secondary Outcome Measures
NameTimeMethod
Current treatment status of Chinese patients with type 1 diabetes3 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.

Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes3 years

Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes

Trial Locations

Locations (101)

Anqing Municipal Hospital

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Anqing, Anhui, China

The First Affiliated Hospital of Bengbu Medical University

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Bengbu, Anhui, China

Hefei First People's Hospital

🇨🇳

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

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Hefei, Anhui, China

The First Affiliated Hospital of USTC,

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Hefei, Anhui, China

The second People's Hospital,wuhu

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Wuhu, Anhui, China

China-Japan Friendship Hospital

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Beijing, Beijing, China

Peking Union Medical College Hospital

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Beijing, Beijing, China

Peking University Shenzhen Hospital

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Beijing, Beijing, China

Peking University Shougang Hospital

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Beijing, Beijing, China

Childrens Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

The First Affiliated Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

University-Town Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

Fujian Medical University second Affiliated Hospital

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Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University

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Fuzhou, Fujian, China

Quanzhou First Hospital.Fujian

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Quanzhou, Fujian, China

Xiamen Fifth Hospital

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Xiamen, Fujian, China

Xiamen Hospital of T.C,M.

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Xiamen, Fujian, China

Zhangshang Hospital Xiamen University

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Xiamen, Fujian, China

Gansu Provincial central Hospital

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Gansu, Gansu, China

Lanzhou University Second Hospital

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Lanzhou, Gansu, China

Affiliated Hospital of Youjiang Medical University for Nationalities

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Guangxi, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

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Guangxi, Guangxi, China

The people's Hospital of Guangxi Zhuang Autonomous Region

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Guangxi, Guangxi, China

The Second Affiliated Hospital of Guangxi Medical University

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Guangxi, Guangxi, China

The First People's Hospital of Qinzhou

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Qinzhou, Guangxi, China

Yulin Red Cross Hospital

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Yulin, Guangxi, China

Affiliated Hospital of Guangdong Medical University

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Guangdong, Guangzhou, China

GuangZhou Eighth People 's Hospital ,GuangZhou Medical University

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Guangzhou, Guangzhou, China

The Fifth Affiliated Hospital of Guangzhou Medical University

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Guangzhou, Guangzhou, China

The First Affiliated Hospital of Shantou University Medical College

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Guangzhou, Guangzhou, China

The Third Affiliated Hospital of Guangzhou Medical University

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Guangzhou, Guangzhou, China

The Third Hospital of Guangzhou Traditional Chinese Medical University

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Guangzhou, Guangzhou, China

People'S Hospital of Anshun City Guizhou Province

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Anshun, Guizhou, China

Maternal and Child Health Hospital of Guiyang City

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Guiyang, Guizhou, China

Guiqian International General Hospital

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Guizhou, Guizhou, China

the First People'S Hospital of Zunyi

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Zunyi, Guizhou, China

The First Hospital Of Qinhuangdao

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Qinhuangdao, Hebei, China

Hebei Provincial People's Hospital

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Shijia Zhuang, Hebei, China

The Second Hospital Of Hebe Medical University

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Shijia Zhuang, Hebei, China

Tangshan City Workers Hospital

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Tangshan, Hebei, China

Heilongjiang Provincial Hospital

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Ha'erbin, Heilongjiang, China

The First Affiliated Hospital of Harbin Medical University

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Ha'erbin, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University

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Ha'erbin, Heilongjiang, China

The 2nd Affiliated Hospital of Harbin Medical University

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Haerbin, Heilongjiang, China

The central hospital of nanyang

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Nanyang, Henan, China

First Affiliated Hospital of Xinxiang Medical University

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Xinxiang, Henan, China

Xinxiang central hospital

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Xinxiang, Henan, China

Henan Provincial Peoples Hospital

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Zhengzhou, Henan, China

People'S Hospital of Zhengzhou

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Zhengzhou, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

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Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

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Zhengzhou, Henan, China

Zhoukou central hospital

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Zhoukou, Henan, China

The central hospital of zhumadian

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Zhumadian, Henan, China

Jingmen Central Hospital

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Jingmen, Hubei, China

Jingzhou central hospital

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Jingzhou, Hubei, China

The central hospital of wuhan

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Wuhan, Hubei, China

Tongji Hospital

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Wuhan, Hubei, China

the First People'S Hospital of Lianyungang

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Lianyungang, Jiangsu, China

Jianhua Ma

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Nanjing, Jiangsu, China

Jiangsu province hospital of Chinese Medical

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Nanjing, Jiangsu, China

Affiliated hospital of nantong university

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Nantong, Jiangsu, China

The first affiliated hospital of soochow university

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Suzhou, Jiangsu, China

Wuxi People's Hospital

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Wuxi, Jiangsu, China

Xuzhou Central Hospital

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Xuzhou, Jiangsu, China

The First Affiliated Hospital of Gannan Medical University

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Gannan, Jiangxi, China

The First Affiliated Hospital of Nanchang University

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Nanchang, Jiangxi, China

Jilin Province People's Hospital

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Jilin, Jilin, China

The First Hospital of Jilin University

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Jilin, Jilin, China

The Second Norman Bethune Hospital of Jilin University

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Jilin, Jilin, China

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

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Shenyang, Liaoning, China

The People's Hospital Of Liaoning Province

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Shenyang, Liaoning, China

Affiliated Hospital of Inner Mongolia University for the Nationalities

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Neimeng, neimenggu, China

Inner Mongolia Medical University Affiliated Hospital

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Neimeng, neimenggu, China

Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital

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Yinchuan, Ningxia, China

The fifth People's Hospital of Qinghai Province

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Qinghai, Qinghai, China

Binzhou People's Hospital

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Binzhou, Shandong, China

Affiliated Hospital of Jining Medical University

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Jining, Shandong, China

Liaocheng People's Hospital

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Liaocheng, Shandong, China

Linyi People's Hospital

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Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

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Qingdao, Shandong, China

People's Hospital Of Rizhao

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Rizhao, Shandong, China

Zibo Central Hospital

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Zibo, Shandong, China

Shanghai Tenth People'S Hospital

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Shanghai, Shanghai, China

Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine

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Shanghai, Shanghai, China

Baoji Central Hospital

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Baoji, Shanxi, China

Weinan Central Hospital

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Weinan, Shanxi, China

The first affiliated hospital of xi'an jiaotong university

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Xi'an, Shanxi, China

The second affiliated hospital of xi'an jiaotong university

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Xi'an, Shanxi, China

The first hospital of yulin

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Yulin, Shanxi, China

Chengdu University Affiliated Hospital

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Chengdu, Sichuan, China

Piduoqudierrenmingyiyuan

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Chengdu, Sichuan, China

People's Hospital of Xinjiang Uygur Autonomous Region

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Xinjiang, Xinjiang, China

The First Affiliated Hospital of Shihezi University Medical School

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Xinjiang, Xinjiang, China

The First Affiliated Hospital of Xinjiang Medical University

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Xinjiang, Xinjiang, China

Urumqi First People's Hospital

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Xinjiang, Xinjiang, China

Xinjiang Construction Corps fourth division hospital

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Xinjiang, Xinjiang, China

The Fifth Affiliated Hospital of Xinjiang Medical University

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Xinxiang, Xinjiang, China

Yunnan First People's Hospital

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Yunnan, Yunnan, China

Yunnan University Affiliated Hospital

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Yunnan, Yunnan, China

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