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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM group |
| ||
| SMBG group |
| ||
| Control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement Rate of Glucose Metabolism During the Perinatal Period | From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum. |
| Measure | Description | 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 |
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Inclusion Criteria: All must be met
Exclusion Criteria: Any one met leads to exclusion
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu | Contact | 8618155394955 | 2543481029@stu.njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu women and children health hospital | Recruiting | Nanjing | China |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. |
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| Control | Other | Participants will receive standard prenatal care without additional glucose monitoring interventions |
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| 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) |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |