Clinical trial NCT03811470: China Diabetes Registry by Metabolic Management Center
Official title: China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Type1 Diabetes Mellitus
Monogenetic Diabetes
Pancreatogenic Diabetes
Drug-Induced Diabetes Mellitus
Other Forms of Diabetes Mellitus
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

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

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: 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：

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.

Eligibility criteria: Main 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

Main 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

Primary outcomes:
measure: Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity
timeFrame: through study completion, up to 20 years
measure: Microvascular morbidity
timeFrame: through study completion, up to 20 years
measure: Mortality
timeFrame: through study completion, up to 20 years
measure: Major infections - pulmonary and non-pulmonary requiring hospitalizations
timeFrame: through study completion, up to 20 years
measure: Heart failure
timeFrame: through study completion, up to 20 years
measure: Neuropathy
timeFrame: through study completion, up to 20 years
measure: All cancers
timeFrame: through study completion, up to 20 years
Secondary outcomes:
measure: HbA1c (%)
timeFrame: through study completion, up to 20 years
measure: Fasting and postprandial glucose (mmol/L)
timeFrame: through study completion, up to 20 years
measure: Blood pressures (mmHg)
timeFrame: through study completion, up to 20 years
measure: lipids (mg/dl)
timeFrame: through study completion, up to 20 years
measure: Body mass index (BMI)
timeFrame: through study completion, up to 20 years
measure: Visceral fat (cm^2)
timeFrame: through study completion, up to 20 years
measure: Health related quality of life
timeFrame: through study completion, up to 20 years
measure: Cognitive function
timeFrame: through study completion, up to 20 years
measure: Psychological well being
timeFrame: through study completion, up to 20 years
measure: Cost-effectiveness
timeFrame: through study completion, up to 20 years
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: National Metabolic Management center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.