Gestational Lifestyle & Outcomes Wellness

Nanjing Medical University

Status: Enrolling

Conditions: GDM

Treatments: Behavioral: Behavioral Self-Monitoring of Blood Glucose; Device: cgm; Other: Control

Study type: Observational

Funder types: Other

Identifiers

NCT07263412

GLOW-GDM-COHORT-2024

Details and patient eligibility

About

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)

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,000 participants in 3 patient groups

CGM group

Treatment:

Device: cgm

SMBG group

Treatment:

Behavioral: Behavioral Self-Monitoring of Blood Glucose

Control group

Treatment:

Other: Control