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The goal of this observational study is to reveal the natural history of diabetes and the occurrence and development patterns of its complications, to evaluate the effectiveness of diabetes interventions, and to assess the health and medical burdens caused by diabetes in Tianjin, based on the medical records and health big data in Tianjin and correspondingly constructed diabetes-specific cohort.
This study was conducted through the University-Enterprise Joint Laboratory for Diabetes Epidemiology Research at Tianjin Medical University. Retrospective and ongoing medical records and health big data from 396983 diabetes patients treated in secondary and tertiary hospitals in Tianjin between 2009 and 2024 were collected to establish a diabetes population cohort. Using advanced data mining techniques, multi-dimensional data including electronic health records (EHRs), medical imaging data, and wearable device metrics were analyzed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Complications | Diabetic Complications: diabetic retinopathy,diabetic nephropathy,cerebral infarction,coronary artery disease The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases. The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m Diagnosis of diabetic retinopathy by fundus examination. Diagnostic criteria for cerebral infarction are ICD codes or the doctor's diagnosis. Data collection through chart review, patient self-reporting, imaging | Baseline and week 520 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Average level of glucose: including Glycated Hemoglobin (HbA1c), the mean of fasting glucose(FG) Glucose Variability: including standard deviation, coefficient of variation of HbA1c and FG. | baseline and week 520 |
| Death |
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Inclusion Criteria:
Exclusion Criteria:
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This study was conducted through the University-Enterprise Joint Laboratory for Diabetes Epidemiology Research at Tianjin Medical University, China. Longitudinal multi-source health big data from 2009 to 2024 (encompassing 396,983 individuals with diabetes treated in secondary and tertiary healthcare facilities in Tianjin) were integrated to establish a representative diabetes population cohort.
Access to raw datasets is restricted under legally binding agreements with the collaborating institutions, as these prohibit data sharing with third parties. However, de-identified aggregate findings, statistical summaries, or the study protocol can be made available upon reasonable request to the Principal Investigator (PI).
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This study is a real-world observational study and does not involve individual interventions or corresponding group assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort Comparising Patients With Diabetes | This dynamic cohort comparised 396983 diabetic patients who were enrolled in second- and tertiary-level hospitals in Tianjin during 2009-2024. All the participants had at least three medical visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age, fasting blood glucose, and glycosylated hemoglobin were described using mean and standard deviation
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort Comparising Patients With Diabetes | This dynamic cohort comparised 396983 diabetic patients who were enrolled in second- and tertiary-level hospitals in Tianjin during 2009-2024. All the participants had at least three medical visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diabetes Complications | Diabetic Complications: diabetic retinopathy,diabetic nephropathy,cerebral infarction,coronary artery disease The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases. The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m Diagnosis of diabetic retinopathy by fundus examination. Diagnostic criteria for cerebral infarction are ICD codes or the doctor's diagnosis. Data collection through chart review, patient self-reporting, imaging | All the participants in the cohort are included in the analysis. | Posted | Count of Participants | Participants | Baseline and week 520 |
|
This study is a real-world observational study and information on adverse events are not available .
Deaths and adverse events were not assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort Comparising Patients With Diabetes | This dynamic cohort comparised approximately 400,000 diabetic patients who were enrolled in second- and tertiary-level hospitals in Tianjin during 2009-2024. All the participants had at least three medical visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhenqiang Song, M.S., Associate Professor and Master's Supervisor | Tianjin Medical University | 8622-18602276218 | Zsong@tmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2025 | May 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2025 | May 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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death from all cause, diabetes complications, and cancer.
| baseline and week 520 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| medical history | Count of Participants | Participants | No |
|
| fasting glucose | Mean | Standard Deviation | mmol/L |
|
| glycated hemoglobin | Mean | Standard Deviation | % |
|
| Coronary Artery Disease |
The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases.The results for each outcome measure are presented in a table in which the columns represent the study's arms or comparison (analysis) groups and the rows present summary-level data. Each statistical analysis is similarly reported in a table that immediately follows the relevant outcome measure. |
| OG001 | Cerebral Infarction | Acute Onset and Symptomatic Features Sudden symptom onset, reaching peak within minutes to several hours, characterized by focal neurological deficits (e.g., unilateral limb weakness/numbness, speech disorders, facial asymmetry, visual disturbances, etc.). Symptom duration exceeds 24 hours, or imaging reveals a responsible ischemic lesion (e.g., CT hypodensity, MRI diffusion restriction). Imaging Evidence Head CT Scan: Excludes intracranial hemorrhage during the acute phase; low-density infarct lesions appear 24-48 hours post-onset. MRI (DWI Sequence): Highly sensitive, detecting ischemic lesions within minutes of symptom onset; preferred for early diagnosis. Vascular Imaging (CTA/MRA): Evaluates stenosis or occlusion of carotid/intracranial arteries, clarifying vascular lesion location and severity. Etiological Classification (at least one criterion must be met) Large Artery Atherosclerosis Type: Vascular stenosis >50% or occlusion with pathological atherosclerosis changes, excluding cardioembolic sources. Cardioembolic Type: Emboli of cardiac origin (e.g., atrial fibrillation, post-myocardial infarction mural thrombi) causing cerebral arterial occlusion, supported by ECG/echocardiographic evidence. Small Artery Occlusion Type (Lacunar Infarction): Infarct diameter <1.5-2.0 cm, predominantly in hypertensive patients, with mild symptoms and favorable prognosis. |
| OG002 | Diabetic Retinopathy | Diagnosis of diabetic retinopathy by fundus examination. |
| OG003 | Diabetic Nephropathy | The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m |
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| Secondary | Glycemic Control | Average level of glucose: including Glycated Hemoglobin (HbA1c), the mean of fasting glucose(FG) Glucose Variability: including standard deviation, coefficient of variation of HbA1c and FG. | Posted | Mean | Standard Deviation | mmol/L | baseline and week 520 |
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| Secondary | Death | death from all cause, diabetes complications, and cancer. | Posted | Count of Participants | Participants | baseline and week 520 |
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| 0 |
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