Gestational Lifestyle & Outcomes Wellness

NCT ID: NCT07263412

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-25

Study Completion Date

2028-11-30

Brief Summary

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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)

Detailed Description

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Conditions

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GDM

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CGM group

cgm

Intervention Type 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.

SMBG group

Behavioral Self-Monitoring of Blood Glucose

Intervention Type BEHAVIORAL

Participants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care.

Control group

Control

Intervention Type OTHER

Participants will receive standard prenatal care without additional glucose monitoring interventions

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Control

Participants will receive standard prenatal care without additional glucose monitoring interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu women and children health hospital

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wu

Role: CONTACT

8618155394955

Facility Contacts

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Wu

Role: primary

+8618155394955

Role: backup

Other Identifiers

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GLOW-GDM-COHORT-2024

Identifier Type: -

Identifier Source: org_study_id

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