RecruitingNCT07263412

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)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

1,000 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Interventions

DEVICEcgm

Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.

BEHAVIORALBehavioral 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.

OTHERControl

Participants will receive standard prenatal care without additional glucose monitoring interventions


Locations(1)

Jiangsu women and children health hospital

Nanjing, China

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