Precision Medicine of Diabetes Program in China

Diabetes Clinical Trial

— PDC  

Official title:

Precision Medicine of Diabetes Program in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320600
• Other study ID #: PDC
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with diabetes according to WHO 1999 criteria

Exclusion Criteria:

• with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• no intervention
It's an observational study, no intervention included

Locations

Country	Name	City	State
China	the Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To establish a model for hypoglycemic therapy	To establish a model for hypoglycemic therapy selection, and compare the rate of HbA1c<7% in patients who are in accordance with the model choice and those who aren't.	January 1st 2024 to December 31th 2028
Primary	The currency analysis of diabetes classification	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.	July 1st 2023 to December 31th 2023
Secondary	To establish a model for predicting diabetic retinopathy	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.	January 1st 2024 to December 31th 2028
Secondary	To establish a model for predicting diabetic kidney disease	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.	January 1st 2024 to December 31th 2028
Secondary	To establish a model for predicting diabetic neuropathy	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.	January 1st 2024 to December 31th 2028