GDM
Conditions
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)
Interventions
DEVICEcgm
Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.
BEHAVIORALBehavioral 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.
OTHERControl
Participants will receive standard prenatal care without additional glucose monitoring interventions
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention | From participant enrollment (23-24+6 weeks of gestation) to 6 weeks 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) |
| Long-term Incidence of Cardiovascular Disease (CVD) | From 6 months postpartum to 2 years postpartum |
Countries
China
Contacts
Primary ContactWu
Outcome results
None listed