Diabetes Mellitus
Conditions
Keywords
cohort study, diabets complication, etiology, clinical epidemiology, health economic evaluation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDiet
Sponsors
Tianjin Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with diabetes * Patients with three or more recorded visits * The following information was complete at the first visit: age, sex, Blood Glucoseor ,glycated hemoglobin(HbA1c)
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Complications | Baseline and week 520 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | baseline and week 520 | 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. |
| Death | baseline and week 520 | death from all cause, diabetes complications, and cancer. |
Participant flow
Pre-assignment details
This study is a real-world observational study and does not involve individual interventions or corresponding group assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 396,983 |
| Total | 396,983 |
Baseline characteristics
| Characteristic | Cohort Comparising Patients With Diabetes |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13 |
| fasting glucose | 10.19 mmol/L STANDARD_DEVIATION 4.01 |
| glycated hemoglobin | 7.43 % STANDARD_DEVIATION 3.22 |
| medical history The number of people with hypertension | 230484 Participants |
| medical history The number of people without hypertension | 166499 Participants |
| Race/Ethnicity, Customized Race Asian | 396983 Participants |
| Race/Ethnicity, Customized Race Non-Asian | 0 Participants |
| Region of Enrollment China | 396983 Participants |
| Sex: Female, Male Female | 181412 Participants |
| Sex: Female, Male Male | 215571 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: Baseline and week 520
Population: All the participants in the cohort are included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary Artery Disease | Diabetes Complications | Patients presenting with any of the aforementioned clinical outcomes | 10263 Participants |
| Coronary Artery Disease | Diabetes Complications | Patients presenting without any of the aforementioned clinical outcomes | 386720 Participants |
| Cerebral Infarction | Diabetes Complications | Patients presenting without any of the aforementioned clinical outcomes | 299119 Participants |
| Cerebral Infarction | Diabetes Complications | Patients presenting with any of the aforementioned clinical outcomes | 97864 Participants |
| Diabetic Retinopathy | Diabetes Complications | Patients presenting with any of the aforementioned clinical outcomes | 59029 Participants |
| Diabetic Retinopathy | Diabetes Complications | Patients presenting without any of the aforementioned clinical outcomes | 337954 Participants |
| Diabetic Nephropathy | Diabetes Complications | Patients presenting with any of the aforementioned clinical outcomes | 69822 Participants |
| Diabetic Nephropathy | Diabetes Complications | Patients presenting without any of the aforementioned clinical outcomes | 327161 Participants |
Secondary
Death
death from all cause, diabetes complications, and cancer.
Time frame: baseline and week 520
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary Artery Disease | Death | Number of all-cause deaths | 21669 Participants |
| Coronary Artery Disease | Death | Number of deaths not due to all causes | 375314 Participants |
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.
Time frame: baseline and week 520
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coronary Artery Disease | Glycemic Control | 8.7 mmol/L | Standard Deviation 3.36 |