Gestational Lifestyle & Outcomes Wellness

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)

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)

Study Overview

• Status: Recruiting
• Conditions: GDM
• Intervention / Treatment: Device: cgm; Behavioral: Behavioral Self-Monitoring of Blood Glucose; Other: Control

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Wu; Phone Number: 8618155394955; Email: 2543481029@stu.njmu.edu.cn

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Jiangsu women and children health hospital
    • Contact: Wu; Phone Number: +8618155394955; Email: 2543481029@stu.njmu.edu.cn
    • Contact: Email: 2543481029@stu.njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: Control; Participants will receive standard prenatal care without additional glucose monitoring interventions
CGM group	Device: cgm; Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.
SMBG group	Behavioral: Behavioral Self-Monitoring of Blood Glucose; Participants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement Rate of Glucose Metabolism During the Perinatal Period	From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Obesity Rate in Offspring	From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: GLOW-GDM-COHORT-2024