RecruitingNCT07314944

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

Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study

Sponsor

University of Split, School of Medicine

Enrollment

100 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Gestational Diabetes

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how sleep quality and daily lifestyle habits affect blood sugar control and pregnancy outcomes in women who have been diagnosed with gestational diabetes — a type of diabetes that develops during pregnancy. **You may be eligible if...** - You are a pregnant woman aged 18 or older - You have recently been diagnosed with gestational diabetes - You are between 24 and 34 weeks pregnant at enrollment - You are able to fill out questionnaires about sleep, anxiety, eating habits, and lifestyle - You can use a smartphone and a continuous glucose monitor (if in the home-monitoring group) **You may NOT be eligible if...** - You had type 1 or type 2 diabetes before becoming pregnant - You currently have preeclampsia or another serious pregnancy complication - You have a major psychiatric disorder that would interfere with participation - You regularly take sedatives or anxiety medications - You plan to deliver at a hospital outside the study network Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERHome-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.

OTHERInpatient 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.

Locations(1)

University hospital of Split

Split, Croatia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07314944

Related Trials

Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes

NCT073369142 locations

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

NCT065476191 location