Precision Medicine of Diabetes Program in China
- Conditions
- Diabetes
- Interventions
- Other: no intervention
- Registration Number
- NCT06320600
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- Brief Summary
The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120000
- Patients diagnosed with diabetes according to WHO 1999 criteria
- with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective PDC cohort no intervention The study will include diabetes patients diagnosed within 1 year (including 1 year) from both inpatient and outpatient medical record systems between January 2022 and December 2022. Each center enrolls approximately 1000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 30,000 participants. Prospective PDC cohort no intervention The study centers will enroll diabetes patients diagnosed within 1 year (including 1 year) from both outpatient and inpatient services between January 2024 and December 2024. Each center sees approximately 3000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 90,000 participants. The patients will be followed up for a period of 5 years.
- Primary Outcome Measures
Name Time Method The currency analysis of diabetes classification July 1st 2023 to December 31th 2023 To assess the accuracy rate of diabetes classification diagnoses according to "Classification of diabetes mellitus in China: an expert consensus statement" and explore variations across centers in different regions and hospital levels.
- Secondary Outcome Measures
Name Time Method To establish a model for predicting diabetic neuropathy January 1st 2024 to December 31th 2028 To establish a model for diabetic neuropathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the outcome of patients.
To establish a model for predicting diabetic retinopathy January 1st 2024 to December 31th 2028 To establish a model for diabetic retinopathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the retinopathy outcome of patients.
To establish a model for predicting diabetic kidney disease January 1st 2024 to December 31th 2028 To establish a model for diabetic kidney disease (DKD) prediction, and calculate the sensitivity and specificity of the model were by comparing with the DKD outcome of patients.
Trial Locations
- Locations (1)
the Second Xiangya Hospital
🇨🇳Changsha, Hunan, China