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NCT Number: NCT03811470

China Diabetes Registry by Metabolic Management Center

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Metabolic Management center

Multiple Locations, China

Location status: Recruiting

Location contact

Guang Ning, Professor

CONTACT

[email protected]

8621-64370045 ext. 671817

Guang Ning, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard diabetes management model in each MMC center

Other

Standard diabetes management model in each MMC center

Primary outcomes

  1. Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity

    Time frame: through study completion, up to 20 years

  2. Microvascular morbidity

    Time frame: through study completion, up to 20 years

  3. Mortality

    Time frame: through study completion, up to 20 years

  4. Major infections - pulmonary and non-pulmonary requiring hospitalizations

    Time frame: through study completion, up to 20 years

  5. Heart failure

    Time frame: through study completion, up to 20 years

    including hospitalized or treated heart failure, or heart failure death

  6. 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

  7. 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

  1. HbA1c (%)

    Time frame: through study completion, up to 20 years

  2. Fasting and postprandial glucose (mmol/L)

    Time frame: through study completion, up to 20 years

  3. Blood pressures (mmHg)

    Time frame: through study completion, up to 20 years

  4. lipids (mg/dl)

    Time frame: through study completion, up to 20 years

  5. Body mass index (BMI)

    Time frame: through study completion, up to 20 years

    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2

  6. Visceral fat (cm^2)

    Time frame: through study completion, up to 20 years

  7. Health related quality of life

    Time frame: through study completion, up to 20 years

    Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire

  8. Cognitive function

    Time frame: through study completion, up to 20 years

    Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale

  9. Psychological well being

    Time frame: through study completion, up to 20 years

    using physiological parameter, questionnaire

  10. Cost-effectiveness

    Time frame: through study completion, up to 20 years

    The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Guang Ning, MD,PHD

CONTACT

[email protected]

008621-64370045 ext. 671817

Sponsors and collaborators

Lead sponsor

Guang Ning

Other

Registry information

Official study title

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

Acronym: CDR-MMC

Important dates

Study start
2017
Primary completion
2037
Study completion
2039
First posted
Jan 22, 2019
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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