About this trial
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
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All the patients who are seen and treated at each MMC centers, and meet the In-/Ex-clusion Criteria will be included in this study
Trial design
Cohort
Prospective
Treatments tested in this trial
Standard diabetes management model in each MMC center
Other interventionStandard diabetes management model in each MMC center
Treatment groups
Trial outcomes
Primary outcomes
Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity
Microvascular morbidity
Mortality
Major infections - pulmonary and non-pulmonary requiring hospitalizations
Secondary outcomes
HbA1c (%)
Fasting and postprandial glucose (mmol/L)
Blood pressures (mmHg)
lipids (mg/dl)
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
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Guang Ning
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor institution