China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000,000
- Locations
- 1
- Primary Endpoint
- Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity
Study Overview
Brief Summary
Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. 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. 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
- 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.
- 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.
- 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
Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. The general population-based survey in China in 2010, using the American Diabetes Association (ADA) 2010 criteria, revealed that the prevalence of diabetes and prediabetes in adults was 11.6% and 50.1%, respectively, indicating that China has the highest diabetes prevalence in Asia and largest absolute disease burden of diabetes in the world. Lifestyle changes, aging, and obesity have become the main reasons for this increase in the prevalence of diabetes.
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：
- 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.
- 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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •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
- •Patients with significantly reduced life expectancy (less than 5 years)
- •With Drug abuse
- •With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis in active phase at enrollment
Outcomes
Primary Outcomes
Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity
Time Frame: through study completion, up to 20 years
Microvascular morbidity
Time Frame: through study completion, up to 20 years
Mortality
Time Frame: through study completion, up to 20 years
Heart failure
Time Frame: through study completion, up to 20 years
including hospitalized or treated heart failure, or heart failure death
Neuropathy
Time Frame: through study completion, up to 20 years
defined as a composite score by the assessment of positive responses among symptoms (by a careful history), sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy, and at least one abnormal nerve conduction
Major infections - pulmonary and non-pulmonary requiring hospitalizations
Time Frame: through study completion, up to 20 years
All cancers
Time Frame: through study completion, up to 20 years
The occurrence of any of the following cancers: prostate, breast, lung/bronchus, endometrial, colon, gastric, leukemia, lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma, etc
Secondary Outcomes
- HbA1c (%)(through study completion, up to 20 years)
- Fasting and postprandial glucose (mmol/L)(through study completion, up to 20 years)
- Blood pressures (mmHg)(through study completion, up to 20 years)
- Health related quality of life(through study completion, up to 20 years)
- Cognitive function(through study completion, up to 20 years)
- lipids (mg/dl)(through study completion, up to 20 years)
- Body mass index (BMI)(through study completion, up to 20 years)
- Visceral fat (cm^2)(through study completion, up to 20 years)
- Cost-effectiveness(through study completion, up to 20 years)
- Psychological well being(through study completion, up to 20 years)
Investigators
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
Shanghai Jiao Tong University School of Medicine