Gestational Lifestyle & Outcomes Wellness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cgm, Behavioral Self-Monitoring of Blood Glucose, Control.
- Who it may be relevant to
- Registry conditions: GDM. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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
- 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. - 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. - Other Control
Participants will receive standard prenatal care without additional glucose monitoring interventions
Primary outcome measures
- Improvement Rate of Glucose Metabolism During the Perinatal Period [Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.]
Secondary outcome measures (6)
- Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention [Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum]
- Long-term Incidence of Type 2 Diabetes Mellitus (T2DM) [Time frame: From 6 months postpartum to 2 years postpartum]
- Incidence of Adverse Outcomes [Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum]
- Long-term Incidence of Cardiovascular Disease (CVD) [Time frame: From 6 months postpartum to 2 years postpartum]
- Abnormal Blood Glucose Status in Offspring [Time frame: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)]
- Obesity Rate in Offspring [Time frame: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)]
Eligibility criteria
Inclusion Criteria: All must be met
- Aged 18-40 years;
- Pre-pregnancy BMI: 18.5 kg/m² < BMI < 28 kg/m²;
- Able to read, understand and sign the informed consent form;
- Receive prenatal care and deliver in the study hospital.
Exclusion Criteria: Any one met leads to exclusion
- Twin or multiple pregnancies;
- Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
- Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
- Complicated with severe liver/kidney diseases;
- Current/recent use of drugs affecting glucose metabolism;
- Mental illness or severe psychological disorders;
- Complicated with severe infection;
- Poor compliance or refusal to use CGM/SMBG.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Jiangsu women and children health hospital — Nanjing
Identifiers
NCT: NCT07263412 · GLOW-GDM-COHORT-2024