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Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes

NCT07314944 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-02

No results posted yet for this study

Summary

The goal of this observational study is to learn how sleep quality, mental health, lifestyle behaviors, and metabolic markers are related to glucose control and pregnancy outcomes in women with gestational diabetes mellitus (GDM). The main questions it aims to answer are:

* Do differences in sleep quality, anxiety levels, and eating behaviors relate to differences in glycemic control in women with GDM?
* Are maternal metabolic markers (such as glucose, liver enzymes, and lipid levels) associated with perinatal outcomes such as birth weight, cesarean delivery, and neonatal complications?
* To compare women who undergo short inpatient glucose monitoring with women who undergo home-based digital glucose monitoring to see if the mode of monitoring is related to differences in sleep, mental health, metabolic profiles, or perinatal outcomes.

Participants will:

* Complete questionnaires on sleep, anxiety, lifestyle, and eating behaviors
* Undergo routine laboratory testing, including metabolic and blood markers.
* Have glucose monitored either during a short hospital stay or through home use of the FreeStyle Libre sensor.
* Be followed from GDM diagnosis (24-34 weeks) until delivery to assess maternal and newborn outcomes

Conditions

  • Gestational Diabetes

Interventions

OTHER

Home-Based Glucose Monitoring

Intervention Description: Home-Based Glucose Monitoring Participants undergo short-term outpatient glucose monitoring as part of routine GDM care. They follow a written schedule for capillary glucose checks while continuing normal daily activities. Data are reviewed at the follow-up visit, where routine laboratory tests and a fetal ultrasound are also performed. This approach reflects standard outpatient management for women able to return for next-day review.

OTHER

Inpatient Glucose Monitoring

Participants undergo a 24-hour hospital admission for scheduled capillary glucose measurements using standard hospital glucometers. During admission, participants follow the hospital's predetermined meal plan and receive continuous nursing oversight. A fetal ultrasound and routine laboratory testing are performed during the stay. This pathway follows usual clinical practice for women who require or are assigned inpatient monitoring based on logistical or clinical considerations.

Sponsors & Collaborators

  • University Hospital of Split

    collaborator OTHER

  • University of Split, School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-10-30
Completion
2030-01-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314944 on ClinicalTrials.gov