An observational study in Diabetes Mellitus, sponsored by Tianjin Medical University. Completed. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Tianjin Medical University · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 396,983 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tianjin Medical University is the lead sponsor of 46 studies on the registry; 29 are open to participants now.
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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.
Exclusion Criteria:
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
Time frame: Baseline and week 520
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.
Time frame: baseline and week 520
Death
death from all cause, diabetes complications, and cancer.
Time frame: baseline and week 520
| Milestone | Cohort Comparising Patients With Diabetes |
|---|---|
| Started | 396983 |
| Completed | 396983 |
| Not completed | 0 |
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
| Participants | Coronary Artery Disease | Cerebral Infarction | Diabetic Retinopathy | Diabetic Nephropathy |
|---|---|---|---|---|
| Patients presenting with any of the aforementioned clinical outcomes | 10263 | 97864 | 59029 | 69822 |
| Patients presenting without any of the aforementioned clinical outcomes | 386720 | 299119 | 337954 | 327161 |
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.
| mmol/L | Mean Fasting Blood Glucose Level of the Population |
|---|---|
| Glycemic Control | 8.7 ± 3.36 |
death from all cause, diabetes complications, and cancer.
| Participants | All Cause |
|---|---|
| Number of all-cause deaths | 21669 |
| Number of deaths not due to all causes | 375314 |
Collected over This study is a real-world observational study and information on adverse events are not available .. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort Comparising Patients With Diabetes | — | — | — |
Age, fasting blood glucose, and glycosylated hemoglobin were described using mean and standard deviation
| Age, Continuous(years) | Cohort Comparising Patients With Diabetes |
|---|---|
| Mean | 58 ± 13 |
| Sex: Female, Male(Participants) | Cohort Comparising Patients With Diabetes |
|---|---|
| Female | 181412 |
| Male | 215571 |
| Race/Ethnicity, Customized(Participants) | Cohort Comparising Patients With Diabetes |
|---|---|
| Race — Asian | 396983 |
| Race — Non-Asian | 0 |
| Region of Enrollment(Participants) | Cohort Comparising Patients With Diabetes |
|---|---|
| China | 396983 |
| medical history(Participants) | Cohort Comparising Patients With Diabetes |
|---|---|
| The number of people with hypertension | 230484 |
| The number of people without hypertension | 166499 |
| fasting glucose(mmol/L) | Cohort Comparising Patients With Diabetes |
|---|---|
| Mean | 10.19 ± 4.01 |
| glycated hemoglobin(%) | Cohort Comparising Patients With Diabetes |
|---|---|
| Mean | 7.43 ± 3.22 |
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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).
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University