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Type1 Diabetes MellitusNCT06606509

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

An observational study of Type1 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 101 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Type1 Diabetes Mellitus
What is being tested?
Continuous Glucose Monitoring System (GX-01S)
How many people
1,000 participants
Where
101 sitesChina
Study dates
7 Nov 2024to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

101 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianhua Ma, Doctor contact

18951670116 ext. +8618951670116

majianhua196503@126.com

101 sites in 1 country

China101 sites

  • Anqing Municipal Hospital

    Anqing, Anhui

    Daxiang Huang, Doctor, 13955660703

  • People'S Hospital of Anshun City Guizhou Province

    Anshun, Guizhou

    Yu Li, Doctor, 15338536945

  • Baoji Central Hospital

    Baoji, Shanxi

    Lifen Ma, Doctor, 17392627866

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

    Weixin Qi, Doctor, 15801444838

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

    Miao Yu, Doctor, 18601255957

  • Peking University Shenzhen Hospital

    Beijing, Beijing Municipality

    Xiaofen Lian, Doctor, 15013559903

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

    Lan Wei, Doctor, 15801444838

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

    Xiaolei Hu, Doctor, 13855216339

  • Binzhou People's Hospital

    Binzhou, Shandong

    Wen Yu, Doctor, 18554301318

  • Chengdu University Affiliated Hospital

    Chengdu, Sichuan

    Shan Wang, Doctor, 18140151533

  • Piduoqudierrenmingyiyuan

    Chengdu, Sichuan

    Xueqin Yan, Doctor, 136 8817 5468

  • Childrens Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Li Li, Doctor, 18696968656

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Zhihong Wang, Doctor, 13883021919

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Gangyi Yang, Doctor, 13637796061

  • University-Town Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Houdi Zhou, Doctor, 13512397347

  • Fujian Medical University second Affiliated Hospital

    Fuzhou, Fujian

    Huibin Huang, Doctor, 13313872001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Sunjie Yan, Doctor, 13805015737

  • The First Affiliated Hospital of Gannan Medical University

    Gannan, Jiangxi

    Shihua Hong, Doctor, 13576709593

  • Gansu Provincial central Hospital

    Gansu, Gansu

    Bo Sun, Doctor, 13369310895

  • Affiliated Hospital of Guangdong Medical University

    Guangdong, Guangzhou

    Juhong Yang, Doctor, 13821024560

  • Affiliated Hospital of Youjiang Medical University for Nationalities

    Guangxi, Guangxi

    Biaoliang Wu, Doctor, 13977621889

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, Guangxi

    Yingfen Qin, Doctor, 13607862619

  • The people's Hospital of Guangxi Zhuang Autonomous Region

    Guangxi, Guangxi

    Luwen Chen, Doctor, 18677181430

  • The Second Affiliated Hospital of Guangxi Medical University

    Guangxi, Guangxi

    Yuzhen Liang, Doctor, 13517665676

  • GuangZhou Eighth People 's Hospital ,GuangZhou Medical University

    Guangzhou, Guangzhou

    Yajuan Han, Doctor, 13763393673

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangzhou

    Chunping Zeng, Doctor, 13500260675

  • The First Affiliated Hospital of Shantou University Medical College

    Guangzhou, Guangzhou

    Kun Lin, Doctor, 13556422916

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangzhou

    Ying Zhang, Doctor, 13556001042

  • The Third Hospital of Guangzhou Traditional Chinese Medical University

    Guangzhou, Guangzhou

    Feng Liu, Doctor, 15989185374

  • Maternal and Child Health Hospital of Guiyang City

    Guiyang, Guizhou

    Aimin Gao, Doctor, 13985467171

  • Guiqian International General Hospital

    Guizhou, Guizhou

    Yan Zhang, Doctor, 18685018424

  • The 2nd Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang

    Yanan Ni, Doctor, 13644501246

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang

    Binhong Duan, Doctor, 13796663517

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Hongyu Kuang, Doctor, 13339300885

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Zhifeng Cheng, Doctor, 18903602198

  • Hefei First People's Hospital

    Hefei, Anhui

    Fang Lv, Doctor, 15956972035

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Qiu Zhang, Doctor, 13965015060

  • The First Affiliated Hospital of USTC,

    Hefei, Anhui

    Wei Wang, Doctor, 13965144659

  • Jilin Province People's Hospital

    Jilin City, Jilin

    Yadong Sun, Doctor, 15843076585

  • The First Hospital of Jilin University

    Jilin City, Jilin

    Guixia Wang, Doctor, 15843081103

  • The Second Norman Bethune Hospital of Jilin University

    Jilin City, Jilin

    Hanqing Cai, Doctor, 13674315020

  • Jingmen Central Hospital

    Jingmen, Hubei

    Cuifeng Wei, Doctor, 13971830674

  • Jingzhou central hospital

    Jingzhou, Hubei

    Junli Xue, Doctor, 18972160273

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

    Mei Zhang, Doctor, 13515374089

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

    Jiangong Ren, Doctor, 13099158878

  • the First People'S Hospital of Lianyungang

    Lianyungang, Jiangsu

    Guofeng Wang, Doctor, 189 6132 7083

  • Liaocheng People's Hospital

    Liaocheng, Shandong

    Jie Bai, Doctor, 13346258761

  • Linyi People's Hospital

    Linyi, Shandong

    Qingyu Dong, Doctor, 15092889280

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Jixiong Xu, Doctor, 13307086069

  • Jianhua Ma

    Nanjing, Jiangsu, 210006

  • Jiangsu province hospital of Chinese Medical

    Nanjing, Jiangsu

    Xiqiao Zhou, Doctor, 13951826318

  • Affiliated hospital of nantong university

    Nantong, Jiangsu

    Yunjuan Gu, Doctor, 15851207860

  • The central hospital of nanyang

    Nanyang, Henan

    Xiaojin Zhang, Doctor, 13673371024

  • Affiliated Hospital of Inner Mongolia University for the Nationalities

    Neimeng, Neimenggu

    Hong Chang, Doctor, 139 4755 0162

  • Inner Mongolia Medical University Affiliated Hospital

    Neimeng, Neimenggu

    Wuyun Zhang, Doctor, 15848378806

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yangang Wang, Doctor, 18661807293

  • The fifth People's Hospital of Qinghai Province

    Qinghai, Qinghai

    Mingfu Ma, Doctor, 13519714619

  • The First Hospital Of Qinhuangdao

    Qinhuangdao, Hebei

    Fuzai Yin, Doctor, 13633355511

  • The First People's Hospital of Qinzhou

    Qinzhou, Guangxi

    Pijian Yang, Doctor, 13471719878

  • Quanzhou First Hospital.Fujian

    Quanzhou, Fujian

    Zhichun Sun, Doctor, 13110959700

  • People's Hospital Of Rizhao

    Rizhao, Shandong

    Honghua Fei, Doctor, 18806331051

  • Shanghai Tenth People'S Hospital

    Shanghai, Shanghai Municipality

    Haibing Chen, Doctor, 18930173813

  • Tong Ren Hospitalshanghaijiaotong Universityschool Ofmedicine

    Shanghai, Shanghai Municipality

    Shan Huang, Doctor, 18121226290

  • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Tianshu Gao, Doctor, 181 0245 9018

  • The People's Hospital Of Liaoning Province

    Shenyang, Liaoning

    Binhong Wen, Doctor, 13604925258

  • Hebei Provincial People's Hospital

    Shijiazhuang, Hebei

    Shuchun Chen, Doctor, 13833166283

  • The Second Hospital Of Hebe Medical University

    Shijiazhuang, Hebei

    Lihui Zhang, Doctor, 15803210962

  • The first affiliated hospital of soochow university

    Suzhou, Jiangsu

    Bimin Shi, Doctor, 138 6256 9825

  • Tangshan City Workers Hospital

    Tangshan, Hebei

    Hui Fang, Doctor, 13831581838

  • Weinan Central Hospital

    Weinan, Shanxi

    Yingli Ma, Doctor, 13992307005

  • The central hospital of wuhan

    Wuhan, Hubei

    Zhongjing Wang, Doctor, 13007111056

  • Tongji Hospital

    Wuhan, Hubei

    Zhelong Liu, Doctor, 13986235028

  • The second People's Hospital,wuhu

    Wuhu, Anhui

    Wei Zhang, Doctor, 13965181927

  • Wuxi People's Hospital

    Wuxi, Jiangsu

    Yun Hu, Doctor, 189 5167 0359

  • The first affiliated hospital of xi'an jiaotong university

    Xi’an, Shanxi

    Fengping Lei, Doctor, 18821688160

  • The second affiliated hospital of xi'an jiaotong university

    Xi’an, Shanxi

    Jing Xu, Doctor, 13772151682

  • Xiamen Fifth Hospital

    Xiamen, Fujian

    Jun Mi, Doctor, 15759295993

  • Xiamen Hospital of T.C,M.

    Xiamen, Fujian

    Yi Zhou, Doctor, 13720899619

  • Zhangshang Hospital Xiamen University

    Xiamen, Fujian

    Xiaomin Chen, Doctor, 13860487599

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang, Xinjiang

  • The First Affiliated Hospital of Shihezi University Medical School

    Xinjiang, Xinjiang

    Jun Li, Doctor, 18703093580

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Xinjiang

    Shen Jiang, Doctor, 18999936571

  • Urumqi First People's Hospital

    Xinjiang, Xinjiang

    yu wen, Doctor, 13579868626

  • Xinjiang Construction Corps fourth division hospital

    Xinjiang, Xinjiang

    Jing Xu, Doctor, 18099800011

  • First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Xinxiang central hospital

    Xinxiang, Henan

  • The Fifth Affiliated Hospital of Xinjiang Medical University

    Xinxiang, Xinjiang

    Minzhe Wang, Doctor, 18999858628

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Houfa Geng, Doctor, 180 6871 8580

  • Ningxia Yikedaxuezongyiyuan Xixueguanbing Hospital

    Yinchuan, Ningxia, 20817

    Hong Lei, Doctor, 13909571880

  • Yulin Red Cross Hospital

    Yulin, Guangxi

    Bingna Yao, Doctor, 15977068193

  • The first hospital of yulin

    Yulin, Shanxi

    Aihua Jia, Doctor, 18992275174

  • Yunnan First People's Hospital

    Yunnan, Yunnan

    Yan Wang, Doctor, 13888612322

  • Yunnan University Affiliated Hospital

    Yunnan, Yunnan

    Ying Yang, Doctor, 13808792563

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan

    Huijuan Yuan, Doctor, 13513891997

  • People'S Hospital of Zhengzhou

    Zhengzhou, Henan

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan

    Sensen Du, Doctor, 18903886605

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhoukou central hospital

    Zhoukou, Henan

    Donghui Yang, Doctor, 13938059080

  • The central hospital of zhumadian

    Zhumadian, Henan

    Xiaojin Zhang, Doctor, 13673371024

  • Zibo Central Hospital

    Zibo, Shandong

    Xiaodong Zhao, Doctor, 18678186512

  • the First People'S Hospital of Zunyi

    Zunyi, Guizhou

    Hongjiao Gao, Doctor, 13984910556

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Continuous Glucose Monitoring System (GX-01S)
Keywords
Continuous Glucose Monitoring (CGN), Glucose fluctuations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Monitoring System (GX-01S)Device

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

Study groups in NCT06606509
Study groupRoleWhat they receive
T1DM patientsPatients with Type 1 Diabetes Mellitus (T1DM) will undergo a series of examinations, including physical examinations, surveys, continuous glucose monitoring, and subcutaneous fat ultrasonography.
Receives: Device: Continuous Glucose Monitoring System (GX-01S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. 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

    Measured: 3 years

  3. 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.

    Measured: 3 years

Secondary outcomes (2)

  1. Current treatment status of Chinese patients with type 1 diabetes

    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.

    Measured: 3 years

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

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start7 Nov 2024 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606509
Sponsor's protocol ID
KY20240514-10
Status last verified
Aug 2024
First submitted
26 Aug 2024
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type1 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 101 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianhua Ma, Doctor (18951670116 ext. +8618951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Current status of blood sugar control in Chinese patients with type 1 diabetes (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06606509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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