Gestational Lifestyle & Outcomes Wellness

NCT07263412 | Recruiting

• 1 other identifier: GLOW-GDM-COHORT-2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)

Conditions

GDM

Outcome Measures

Primary Outcomes (1)

• Improvement Rate of Glucose Metabolism During the Perinatal Period

  From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.

Secondary Outcomes (6)

• Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention

  From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum

• Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)

  From 6 months postpartum to 2 years postpartum

• Incidence of Adverse Outcomes

  From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum

• Long-term Incidence of Cardiovascular Disease (CVD)

  From 6 months postpartum to 2 years postpartum

• Abnormal Blood Glucose Status in Offspring

  From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)

Study Arms (3)

CGM group

Device: cgm

SMBG group

Behavioral: Behavioral Self-Monitoring of Blood Glucose

Control group

Other: Control

Interventions

cgm DEVICE

Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.

CGM group

Behavioral Self-Monitoring of Blood Glucose BEHAVIORAL

Participants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care.

SMBG group

Control OTHER

Participants will receive standard prenatal care without additional glucose monitoring interventions

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 1,000 pregnant women with antenatal care registration in the study hospital are enrolled, including 500 Gestational Diabetes Mellitus (GDM) cases (diagnosed via 75g OGTT at 24-28 weeks of gestation with ≥1 abnormal blood glucose value) and 500 normal controls. All participants meet: aged 18-40 years, pre-pregnancy BMI 18.5-28 kg/m², ability to sign informed consent, and prenatal care/delivery in the hospital. Those with multiple pregnancies, pre-gestational diabetes, poorly controlled hypertension, severe organ diseases, or poor compliance are excluded. Participants and their offspring complete perinatal and 2-year postnatal follow-ups.

You may qualify if:

• Aged 18-40 years;
• Pre-pregnancy BMI: 18.5 kg/m² \< BMI \< 28 kg/m²;
• Able to read, understand and sign the informed consent form;
• Receive prenatal care and deliver in the study hospital.

You may not qualify if:

• Twin or multiple pregnancies;
• Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
• Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
• Complicated with severe liver/kidney diseases;
• Current/recent use of drugs affecting glucose metabolism;
• Mental illness or severe psychological disorders;
• Complicated with severe infection;
• Poor compliance or refusal to use CGM/SMBG.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu women and children health hospital

Nanjing, China

RECRUITING

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Wu

CONTACT

8618155394955; 2543481029@stu.njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

CN (1)