Health TrialsbyHealthPanel

Gestational Lifestyle & Outcomes Wellness

ConditionGDM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

  • Control

    Other intervention

    Participants will receive standard prenatal care without additional glucose monitoring interventions

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: CGM group1 intervention
Group B: SMBG group1 intervention
Group C: Control group1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)

Time frame
From 6 months postpartum to 2 years postpartum
3

Incidence of Adverse Outcomes

Time frame
From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum
4

Long-term Incidence of Cardiovascular Disease (CVD)

Time frame
From 6 months postpartum to 2 years postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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