Precision Medicine of Diabetes Program in China

NCT06320600 | Recruiting

• 1 other identifier: PDC
• Study Type: observational
• Target: 120,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To establish a model for predicting diabetic retinopathy

  January 1st 2024 to December 31th 2028

• To establish a model for predicting diabetic kidney disease

  January 1st 2024 to December 31th 2028

• To establish a model for predicting diabetic neuropathy

  January 1st 2024 to December 31th 2028

Other Outcomes (1)

• To establish a model for hypoglycemic therapy

  January 1st 2024 to December 31th 2028

Study Arms (2)

Retrospective PDC cohort

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.

Other: no intervention

Prospective PDC cohort

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.

Other: no intervention

Interventions

no intervention OTHER

It's an observational study, no intervention included

Prospective PDC cohort; Retrospective PDC cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective cohort includes patients diagnosed with diabetes according to WHO 1999 criteria, and the prospective cohort enrolls precisely classified diabetic patients according to "Classification of diabetes mellitus in China: an expert consensus statement".

You may qualify if:

• Patients diagnosed with diabetes according to WHO 1999 criteria

You may not qualify if:

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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

the Second Xiangya Hospital

Changsha, Hunan, 410010, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 20, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CN (1)