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NCT Number: NCT06913153

Tianjin Diabetes and Health Cohort Study

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Primary outcomes

  1. Diabetes Complications

    Time frame: 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 outcomes

  1. Glycemic Control

    Time frame: 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.

  2. Death

    Time frame: baseline and week 520

    death from all cause, diabetes complications, and cancer.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Registry information

Important dates

Study start
2009
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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