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

NCT07276945 | Not Yet Recruiting

• 1 other identifier: 2025-PUMCH-C-021
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes mellitus; continuous glucose monitoring; early diagnosis; mother-child outcomes

Outcome Measures

Primary Outcomes (1)

• Oral Glucose Tolerance Test

  24~28 weeks of pregnancy

Secondary Outcomes (1)

• Adverse maternal and fetal outcomes (Large for Gestational Age and Small for Gestational Age)

  up to 42 weeks of pregnancy

Study Arms (2)

gestational diabetes group

No interventions

Other: No interventions

healthy control group

No interventions

Other: No interventions

Interventions

No interventions OTHER

No interventions

gestational diabetes group; healthy control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women with gestational diabetes and control group

You may qualify if:

• ① Early pregnancy (≤14 weeks) pregnant women;
• ② Singleton pregnancies;
• ③ Early pregnancy psychological scores (PHQ-9 and GAD-7) \<10 points;
• ④ Consent to participate in the study and sign an informed consent form.

You may not qualify if:

• ① Twin or multiple pregnancies;
• ② Diabetes mellitus complicated with pregnancy;
• ③ Severe pregnancy complications;
• ④ Pre-existing significant cardiovascular, hepatic, renal, hematologic, or autoimmune diseases;
• ⑤ History of smoking, alcohol abuse, or narcotic and drug use;
• ⑥ Early pregnancy psychological assessment (PHQ-9 or GAD-7) score ≥10.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Mother's blood, urine, feces, placenta, fetal umbilical cord blood

MeSH Terms

Conditions

Diabetes, Gestational; Disease

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinhua Xiao

  Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China

  STUDY DIRECTOR

Central Study Contacts

Xinhua Xiao

CONTACT

86-10-13911830085; xiaoxh2014@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share