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NCT Number: NCT07263412

Gestational Lifestyle & Outcomes Wellness

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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Key information

Conditions

GDM

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Participants will receive standard prenatal care without additional glucose monitoring interventions

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

  5. 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)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Wu

CONTACT

[email protected]

8618155394955

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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