China Diabetes Registry by Metabolic Management Center

Type 2 Diabetes Mellitus Clinical Trial

— CDR-MMC  

Official title:

China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811470
• Other study ID #: CCEMD-2018-1201
• Status: Recruiting
• Start date: May 31, 2017
• Est. completion date: May 31, 2039

Study information

• Verified date: June 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Guang Ning, MD,PHD
• Phone: 008621-64370045
• Email: gning[@]sibs.ac.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: May 31, 2039
• Est. primary completion date: May 31, 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Drug-Induced Diabetes Mellitus
• Monogenetic Diabetes
• Other Forms of Diabetes Mellitus
• Pancreatogenic Diabetes
• Type 2 Diabetes Mellitus
• Type1 Diabetes Mellitus

Intervention

Other:
• Standard diabetes management model in each MMC center
Standard diabetes management model in each MMC center

Locations

Country	Name	City	State
China	National Metabolic Management center	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Guang Ning

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity		through study completion, up to 20 years
Primary	Microvascular morbidity		through study completion, up to 20 years
Primary	Mortality		through study completion, up to 20 years
Primary	Major infections - pulmonary and non-pulmonary requiring hospitalizations		through study completion, up to 20 years
Primary	Heart failure	including hospitalized or treated heart failure, or heart failure death	through study completion, up to 20 years
Primary	Neuropathy	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	through study completion, up to 20 years
Primary	All cancers	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	through study completion, up to 20 years
Secondary	HbA1c (%)		through study completion, up to 20 years
Secondary	Fasting and postprandial glucose (mmol/L)		through study completion, up to 20 years
Secondary	Blood pressures (mmHg)		through study completion, up to 20 years
Secondary	lipids (mg/dl)		through study completion, up to 20 years
Secondary	Body mass index (BMI)	Body weight (kg) and height (m) will be combined to report BMI in kg/m^2	through study completion, up to 20 years
Secondary	Visceral fat (cm^2)		through study completion, up to 20 years
Secondary	Health related quality of life	Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire	through study completion, up to 20 years
Secondary	Cognitive function	Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale	through study completion, up to 20 years
Secondary	Psychological well being	using physiological parameter, questionnaire	through study completion, up to 20 years
Secondary	Cost-effectiveness	The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire	through study completion, up to 20 years