Individualized Early Diagnosis and Treatment System of Gestational Diabetes Mellitus (GDM) Based on New Continuous Glucose Monitoring (CGM) Technology

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07276945
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • No interventions — OTHER
    No interventions

Study Details

Gestational diabetes mellitus (GDM), as the most common metabolic complication of pregnancy, poses a serious threat to maternal and fetal metabolic health. However, current GDM diagnosis faces several problems such as static, single-point, cumbersome to operate and delayed diagnosis, highlighting an urgent need to establish an individualized system for early prediction, diagnosis, and intervention. This project aims to develop a mother-child cohort covering pregnancy and the perinatal period to propose early diagnostic criteria for GDM based on continuous glucose monitoring (CGM) technology, as well as developing clinically applicable AI-based tools for analyzing and interpreting CGM data, along with strategies to assist in GDM diagnosis. Furthermore, it will investigate CGM parameters and multi-omics biomarkers suitable for predicting maternal and fetal outcomes, culminating in the creation of an intelligent management platform for GDM. This project is expected to enhance the early identification rate of gestational diabetes, potentially advancing the diagnostic and therapeutic window for the condition, thereby improving both short- and long-term maternal and fetal health outcomes.

Key Dates

First listed
Dec 11, 2025
Start date
Dec 10, 2025
Status verified
Dec 2025
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: gestational diabetes group
    No interventions
  • Arm: healthy control group
    No interventions

Primary Outcome Measure

Oral Glucose Tolerance Test [ Time Frame: 24~28 weeks of pregnancy ]

Central Contacts

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