Clinical trial NCT06606509: The Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).
Official title: The Chinese Clinical Research Plan for the Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type1 Diabetes Mellitus
Keywords: Continuous Glucose Monitoring (CGN)
Glucose fluctuations
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Current status of blood sugar control in Chinese patients with type 1 diabetes
timeFrame: 3 years
measure: Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes
timeFrame: 3 years
measure: Potential beneficiary groups of continuous glucose monitoring
timeFrame: 3 years
Secondary outcomes:
measure: Current treatment status of Chinese patients with type 1 diabetes
timeFrame: 3 years
measure: Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
timeFrame: 3 years
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC,
state: Anhui
city: Wuhu
country: China
facility: The second People's Hospital,wuhu
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shenzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Chongqing
country: China
facility: Childrens Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: University-Town Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University second Affiliated Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital.Fujian
state: Fujian
city: Xiamen
country: China
facility: Xiamen Fifth Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen Hospital of T.C,M.
state: Fujian
city: Xiamen
country: China
facility: Zhangshang Hospital Xiamen University
state: Fujian
city: Gansu
country: China
facility: Gansu Provincial central Hospital
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangxi
country: China
facility: Affiliated Hospital of Youjiang Medical University for Nationalities
state: Guangxi
city: Guangxi
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Guangxi
country: China
facility: The people's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guangxi
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Qinzhou
country: China
facility: The First People's Hospital of Qinzhou
state: Guangxi
city: Yulin
country: China
facility: Yulin Red Cross Hospital
state: Guangxi
city: Guangdong
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangzhou
city: Guangzhou
country: China
facility: GuangZhou Eighth People 's Hospital ,GuangZhou Medical University
state: Guangzhou
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangzhou
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangzhou
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangzhou
city: Guangzhou
country: China
facility: The Third Hospital of Guangzhou Traditional Chinese Medical University
state: Guangzhou
city: Anshun
country: China
facility: People'S Hospital of Anshun City Guizhou Province
state: Guizhou
city: Guiyang
country: China
facility: Maternal and Child Health Hospital of Guiyang City
state: Guizhou
city: Guizhou
country: China
facility: Guiqian International General Hospital
state: Guizhou
city: Zunyi
country: China
facility: the First People'S Hospital of Zunyi
state: Guizhou
city: Qinhuangdao
country: China
facility: The First Hospital Of Qinhuangdao
state: Hebei
city: Shijia Zhuang
country: China
facility: Hebei Provincial People's Hospital
state: Hebei
city: Shijia Zhuang
country: China
facility: The Second Hospital Of Hebe Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan City Workers Hospital
state: Hebei
city: Ha'erbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Haerbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: The central hospital of nanyang
state: Henan
city: Xinxiang
country: China
facility: First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinxiang
country: China
facility: Xinxiang central hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
state: Henan
city: Zhengzhou
country: China
facility: People'S Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhoukou
country: China
facility: Zhoukou central hospital
state: Henan
city: Zhumadian
country: China
facility: The central hospital of zhumadian
state: Henan
city: Jingmen
country: China
facility: Jingmen Central Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou central hospital
state: Hubei
city: Wuhan
country: China
facility: The central hospital of wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Lianyungang
country: China
facility: the First People'S Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jianhua Ma
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu province hospital of Chinese Medical
state: Jiangsu
city: Nantong
country: China
facility: Affiliated hospital of nantong university
state: Jiangsu
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Gannan
country: China
facility: The First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jilin
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Jilin
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jilin
country: China
facility: The Second Norman Bethune Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital Of Liaoning Province
state: Liaoning
city: Neimeng
country: China
facility: Affiliated Hospital of Inner Mongolia University for the Nationalities
state: neimenggu
city: Neimeng
country: China
facility: Inner Mongolia Medical University Affiliated Hospital
state: neimenggu
city: Yinchuan
country: China
facility: Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital
state: Ningxia
city: Qinghai
country: China
facility: The fifth People's Hospital of Qinghai Province
state: Qinghai
city: Binzhou
country: China
facility: Binzhou People's Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Rizhao
country: China
facility: People's Hospital Of Rizhao
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tenth People'S Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Weinan
country: China
facility: Weinan Central Hospital
state: Shanxi
city: Xi'an
country: China
facility: The first affiliated hospital of xi'an jiaotong university
state: Shanxi
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shanxi
city: Yulin
country: China
facility: The first hospital of yulin
state: Shanxi
city: Chengdu
country: China
facility: Chengdu University Affiliated Hospital
state: Sichuan
city: Chengdu
country: China
facility: Piduoqudierrenmingyiyuan
state: Sichuan
city: Xinjiang
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Shihezi University Medical School
state: Xinjiang
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Xinjiang
country: China
facility: Urumqi First People's Hospital
state: Xinjiang
city: Xinjiang
country: China
facility: Xinjiang Construction Corps fourth division hospital
state: Xinjiang
city: Xinxiang
country: China
facility: The Fifth Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Yunnan
country: China
facility: Yunnan First People's Hospital
state: Yunnan
city: Yunnan
country: China
facility: Yunnan University Affiliated Hospital
state: Yunnan
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianhua Ma, Doctor
role: STUDY_CHAIR
References: