GLOW Plan: Predicting and Preventing Gestational Diabetes with Lifestyle Support and Glucose Monitoring

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)

This project will test whether combining continuous glucose monitoring, regular self-monitoring, and personalized lifestyle support can help predict and reduce gestational diabetes in pregnant people aged 18–40 who receive care at the participating hospital.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT07263412 on ClinicalTrials.gov

What this trial studies

This multicenter prospective observational cohort will enroll pregnant people who meet the age and pre-pregnancy BMI criteria and follow them through pregnancy and delivery. Participants will undergo continuous glucose monitoring (CGM), routine self-monitoring of blood glucose (SMBG), or standard care while receiving multidisciplinary precision lifestyle support according to the GLOW Plan as implemented at each site. Investigators will collect clinical, metabolic, and behavioral data to identify risk factors and to develop a diagnostic prediction model for gestational diabetes mellitus (GDM). Outcomes include GDM diagnosis, maternal glycemic patterns, and birth outcomes compared across monitoring and management approaches.

Who should consider this trial

Good fit: Pregnant people aged 18–40 with pre-pregnancy BMI between 18.5 and 28 who receive prenatal care and plan to deliver at the participating hospital, and who can read consent forms and use CGM/SMBG, are ideal candidates.

Not a fit: People with multiple pregnancies, pre-existing diabetes, poorly controlled chronic hypertension, severe organ disease or infection, recent use of glucose-altering drugs, significant psychiatric illness, or who cannot comply with CGM/SMBG are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, this could help identify people at high risk for GDM earlier and provide personalized glucose monitoring and lifestyle support to reduce pregnancy complications.

How similar studies have performed: Previous studies using CGM and personalized lifestyle support have shown promise for improving glycemic control in pregnancy and some diagnostic models for GDM exist, though results and accuracy have varied across settings.

Eligibility criteria

Inclusion Criteria: All must be met

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

Exclusion Criteria: Any one met leads to exclusion

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

Where this trial is running

Nanjing

• Jiangsu women and children health hospital — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: Wu

Conditions GDM