Precision Medicine of Diabetes Program in China (PDC)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Estimated): 120000

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410010
      • Recruiting
      • The second xiangya hospital
      • Contact: Shuting Yang; Phone Number: 15200863137; Email: yang_shting@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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".

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; It's an observational study, no intervention included
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; It's an observational study, no intervention included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: PDC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No