Study Results
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Basic Information
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RECRUITING
1000000 participants
OBSERVATIONAL
2017-05-31
2039-05-31
Brief Summary
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Objective
1. The purpose of the present study is to establish a multi-center nationwide prospective database of diabetes patients in MMCs, including clinical data, biological samples library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and prognostic methods related to diabetes and its complications, as well as other metabolic diseases.
2. To collect cross-sectional data from patients seen and treated at each MMC centers so as to evaluate: the current status of care of patients with diabetes and its related complications, as well as other risk factors treatment strategies at these centers. Patients'costs and quality of life (QoL) will also be evaluated.
3. To collect the prospective data of patients treated at each MMC centers in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of all-diabetes related clinical endpoints (including mortality), behavioral changes, psychological well being as well as costs and QoL.
Detailed Description
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In order to meet all the challenges in the treatment of metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in 2016. With advanced medical equipment and Internet of Things (IoT) technology, the MMC is committed to creating an online and offline integrated solution for diabetes, and for the entire spectrum of metabolic disease, to achieve a more convenient and precise model of care for patients. The MMC is focused on establishing highly efficient diagnosis and treatment, as well as comprehensive disease management both in and out of hospital. All MMCs in China have the same structure in terms of facilities, layout, and databases, as well as the same routine daily operations, aiming to establish a platform with standardized diagnosis and treatment of metabolic diseases and their long-term follow-up. This platform of treatment is called the'One Center, One Stop, and One Standard Model'.
The objective of the MMC is to launch a new metabolic disease management model based on the Internet health information platform. It allows the application and evaluation of diabetes treatment strategies at these centers. The proprietary electronic medical database in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and treatment. It will also provide prospective data support including economic evaluation in management of chronic diseases for the Healthy China 2030 strategy.
Objective：
1. The purpose of the present study is to establish a multi-center nationwide prospective database of diabetes patients in MMCs, including clinical data, biological samples library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and prognostic methods related to diabetes and its complications, as well as other metabolic diseases.
2. To collect cross-sectional data from patients seen and treated at each MMC centers so as to evaluate: the current status of care of patients with diabetes and its related complications, as well as other risk factors treatment strategies at these centers. Patients'costs and quality of life (QoL) will also be evaluated.
3. To collect the prospective data of patients treated at each MMC centers in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of all-diabetes related clinical endpoints (including mortality), behavioral changes, psychological well being as well as costs and QoL.
Methods： After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each MMC centers. Then patients will be followed by clinical/laboratory visits at MMC every 3-6 month later on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for glycemic and risk factors control, safety, as well as diabetes-specific complications will be scheduled once a year.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms
Standard diabetes management model in each MMC center
Standard diabetes management model in each MMC center
Interventions
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Standard diabetes management model in each MMC center
Standard diabetes management model in each MMC center
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus based on self-reported history of diagnosed diabetes by clinicians or in line with the current domestic diagnostic criteria for diabetes
* Gender: males and females
* Provide written informed consent
* Satisfactory compliance
Exclusion Criteria
* With Drug abuse
* With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis in active phase at enrollment
18 Years
ALL
No
Sponsors
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Guang Ning
OTHER
Responsible Party
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Guang Ning
Vice-president of Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Chairman of the Chinese National Clinical Research Center for Endocrine and Metabolic Diseases
Locations
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National Metabolic Management center
Multiple Locations, , China
Countries
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Central Contacts
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Facility Contacts
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Guang Ning, Professor
Role: primary
References
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Zhang Y, Wang W, Ning G. Metabolic Management Center: An innovation project for the management of metabolic diseases and complications in China. J Diabetes. 2019 Jan;11(1):11-13. doi: 10.1111/1753-0407.12847. Epub 2018 Oct 3. No abstract available.
Mu L, Li C, Zhao W, Li A, Zhao D, Zhang B. Association between Sleep Duration and Left Ventricular Hypertrophy for Patients with Type 2 Diabetes Mellitus. Int J Endocrinol. 2023 Nov 28;2023:5532778. doi: 10.1155/2023/5532778. eCollection 2023.
Li L, Mi Y, Xu M, Ruan L, Sun J, Song Q. Influence of Dietary Salt Intake on T2D Treatment. Front Endocrinol (Lausanne). 2022 Jun 15;13:926143. doi: 10.3389/fendo.2022.926143. eCollection 2022.
Yang X, Lin Y, Xu GD, Chen YS, Zhou Y, Sun J, Li L. Optimal Cut-Off Values of Visceral Fat Area for Predicting Metabolic Syndrome Among Type 2 Diabetes Patients in Ningbo, China. Diabetes Metab Syndr Obes. 2021 Mar 25;14:1375-1383. doi: 10.2147/DMSO.S304164. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CCEMD-2018-1201
Identifier Type: -
Identifier Source: org_study_id