<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811470</url>
  </required_header>
  <id_info>
    <org_study_id>CCEMD-2018-1201</org_study_id>
    <nct_id>NCT03811470</nct_id>
  </id_info>
  <brief_title>China Diabetes Registry by Metabolic Management Center</brief_title>
  <acronym>CDR-MMC</acronym>
  <official_title>China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang Ning</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and&#xD;
      related mortality worldwide. In order to meet all the challenges in the treatment of&#xD;
      metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in&#xD;
      2016. The objective of the MMC is to launch a new metabolic disease management model based on&#xD;
      the Internet health information platform. It allows the application and evaluation of&#xD;
      diabetes treatment strategies at these centers. The proprietary electronic medical database&#xD;
      in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention,&#xD;
      diagnosis, and treatment. It will also provide prospective data support including economic&#xD;
      evaluation in management of chronic diseases for the Healthy China 2030 strategy.&#xD;
&#xD;
      Objective&#xD;
&#xD;
        1. The purpose of the present study is to establish a multi-center nationwide prospective&#xD;
           database of diabetes patients in MMCs, including clinical data, biological samples&#xD;
           library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and&#xD;
           prognostic methods related to diabetes and its complications, as well as other metabolic&#xD;
           diseases.&#xD;
&#xD;
        2. To collect cross-sectional data from patients seen and treated at each MMC centers so as&#xD;
           to evaluate: the current status of care of patients with diabetes and its related&#xD;
           complications, as well as other risk factors treatment strategies at these centers.&#xD;
           Patients'costs and quality of life (QoL) will also be evaluated.&#xD;
&#xD;
        3. To collect the prospective data of patients treated at each MMC centers in order to&#xD;
           evaluate the strategies for the achievement of treatment goals, changes in management,&#xD;
           control of risk factors, incidence and progression of all-diabetes related clinical&#xD;
           endpoints (including mortality), behavioral changes, psychological well being as well as&#xD;
           costs and QoL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and&#xD;
      related mortality worldwide. The general population-based survey in China in 2010, using the&#xD;
      American Diabetes Association (ADA) 2010 criteria, revealed that the prevalence of diabetes&#xD;
      and prediabetes in adults was 11.6% and 50.1%, respectively, indicating that China has the&#xD;
      highest diabetes prevalence in Asia and largest absolute disease burden of diabetes in the&#xD;
      world. Lifestyle changes, aging, and obesity have become the main reasons for this increase&#xD;
      in the prevalence of diabetes.&#xD;
&#xD;
      In order to meet all the challenges in the treatment of metabolic diseases in China, the&#xD;
      National Metabolic Management Center (MMC) was founded in 2016. With advanced medical&#xD;
      equipment and Internet of Things (IoT) technology, the MMC is committed to creating an online&#xD;
      and offline integrated solution for diabetes, and for the entire spectrum of metabolic&#xD;
      disease, to achieve a more convenient and precise model of care for patients. The MMC is&#xD;
      focused on establishing highly efficient diagnosis and treatment, as well as comprehensive&#xD;
      disease management both in and out of hospital. All MMCs in China have the same structure in&#xD;
      terms of facilities, layout, and databases, as well as the same routine daily operations,&#xD;
      aiming to establish a platform with standardized diagnosis and treatment of metabolic&#xD;
      diseases and their long-term follow-up. This platform of treatment is called the'One Center,&#xD;
      One Stop, and One Standard Model'.&#xD;
&#xD;
      The objective of the MMC is to launch a new metabolic disease management model based on the&#xD;
      Internet health information platform. It allows the application and evaluation of diabetes&#xD;
      treatment strategies at these centers. The proprietary electronic medical database in the MMC&#xD;
      will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and&#xD;
      treatment. It will also provide prospective data support including economic evaluation in&#xD;
      management of chronic diseases for the Healthy China 2030 strategy.&#xD;
&#xD;
      Objective：&#xD;
&#xD;
        1. The purpose of the present study is to establish a multi-center nationwide prospective&#xD;
           database of diabetes patients in MMCs, including clinical data, biological samples&#xD;
           library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and&#xD;
           prognostic methods related to diabetes and its complications, as well as other metabolic&#xD;
           diseases.&#xD;
&#xD;
        2. To collect cross-sectional data from patients seen and treated at each MMC centers so as&#xD;
           to evaluate: the current status of care of patients with diabetes and its related&#xD;
           complications, as well as other risk factors treatment strategies at these centers.&#xD;
           Patients'costs and quality of life (QoL) will also be evaluated.&#xD;
&#xD;
        3. To collect the prospective data of patients treated at each MMC centers in order to&#xD;
           evaluate the strategies for the achievement of treatment goals, changes in management,&#xD;
           control of risk factors, incidence and progression of all-diabetes related clinical&#xD;
           endpoints (including mortality), behavioral changes, psychological well being as well as&#xD;
           costs and QoL.&#xD;
&#xD;
      Methods： After obtaining informed consent, patients will be invited and initiated with a&#xD;
      comprehensive baseline evaluation at each MMC centers. Then patients will be followed by&#xD;
      clinical/laboratory visits at MMC every 3-6 month later on according to individualized&#xD;
      patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for&#xD;
      glycemic and risk factors control, safety, as well as diabetes-specific complications will be&#xD;
      scheduled once a year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 31, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2039</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2037</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Microvascular morbidity</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major infections - pulmonary and non-pulmonary requiring hospitalizations</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart failure</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>including hospitalized or treated heart failure, or heart failure death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropathy</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All cancers</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c (%)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting and postprandial glucose (mmol/L)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressures (mmHg)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipids (mg/dl)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>Body weight (kg) and height (m) will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral fat (cm^2)</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological well being</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>using physiological parameter, questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>through study completion, up to 20 years</time_frame>
    <description>The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000000</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Type1 Diabetes Mellitus</condition>
  <condition>Monogenetic Diabetes</condition>
  <condition>Pancreatogenic Diabetes</condition>
  <condition>Drug-Induced Diabetes Mellitus</condition>
  <condition>Other Forms of Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard diabetes management model in each MMC center</intervention_name>
    <description>Standard diabetes management model in each MMC center</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA, Serum, plasma and full blood samples are retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients who are seen and treated at each MMC centers, and meet the In-/Ex-clusion&#xD;
        Criteria will be included in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus based on self-reported history of diagnosed diabetes by&#xD;
             clinicians or in line with the current domestic diagnostic criteria for diabetes&#xD;
&#xD;
          -  Gender: males and females&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Satisfactory compliance&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Patients with significantly reduced life expectancy (less than 5 years)&#xD;
&#xD;
          -  With Drug abuse&#xD;
&#xD;
          -  With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis&#xD;
             in active phase at enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Guang Ning, MD,PHD</last_name>
    <phone>008621-64370045</phone>
    <phone_ext>671817</phone_ext>
    <email>gning@sibs.ac.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Metabolic Management center</name>
      <address>
        <city>Multiple Locations</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guang Ning, Professor</last_name>
      <phone>8621-64370045</phone>
      <phone_ext>671817</phone_ext>
      <email>gning@sibs.ac.cn</email>
    </contact>
    <investigator>
      <last_name>Guang Ning, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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>
    <PMID>30284373</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Guang Ning</investigator_full_name>
    <investigator_title>Vice-president of Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Chairman of the Chinese National Clinical Research Center for Endocrine and Metabolic Diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811470
org study id: CCEMD-2018-1201
nct id: NCT03811470
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity
time frame: through study completion, up to 20 years
measure: Microvascular morbidity
time frame: through study completion, up to 20 years
measure: Mortality
time frame: through study completion, up to 20 years
measure: Major infections - pulmonary and non-pulmonary requiring hospitalizations
time frame: through study completion, up to 20 years
measure: Heart failure
time frame: through study completion, up to 20 years
description: including hospitalized or treated heart failure, or heart failure death
measure: Neuropathy
time frame: through study completion, up to 20 years
description: 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
measure: All cancers
time frame: through study completion, up to 20 years
description: 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
measure: HbA1c (%)
time frame: through study completion, up to 20 years
measure: Fasting and postprandial glucose (mmol/L)
time frame: through study completion, up to 20 years
measure: Blood pressures (mmHg)
time frame: through study completion, up to 20 years
measure: lipids (mg/dl)
time frame: through study completion, up to 20 years
measure: Body mass index (BMI)
time frame: through study completion, up to 20 years
description: Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
measure: Visceral fat (cm^2)
time frame: through study completion, up to 20 years
measure: Health related quality of life
time frame: through study completion, up to 20 years
description: Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
measure: Cognitive function
time frame: through study completion, up to 20 years
description: Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale
measure: Psychological well being
time frame: through study completion, up to 20 years
description: using physiological parameter, questionnaire
measure: Cost-effectiveness
time frame: through study completion, up to 20 years
description: The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire
arm group label: 1
description: Patients with diabetes mellitus including: type 1 or type 2 diabetes mellitus, monogenetic diabetes, pancreatogenic diabetes, drug-induced diabetes, other forms
intervention type: Other
intervention name: Standard diabetes management model in each MMC center
description: Standard diabetes management model in each MMC center
arm group label: 1
DNA, Serum, plasma and full blood samples are retained
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guang Ning, MD,PHD
phone: 008621-64370045
phone ext: 671817
email: gning@sibs.ac.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
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.
PMID: 30284373
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Guang Ning
investigator title: Vice-president of Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Chairman of the Chinese National Clinical Research Center for Endocrine and Metabolic Diseases
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided