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

Recruitingn/aAges 18 Years - anyFemaleUniversity of Split, School of Medicine
NCT07314944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women aged 18 years or older * New diagnosis of gestational diabetes mellitus (GDM) according to IADPSG criteria * Gestational age 24-34 weeks at enrollment * Able to complete study questionnaires (sleep, anxiety, eating behavior, lifestyle) * Able to provide informed consent * For participants in the home-monitoring pathway: ability to use a smartphone and the FreeStyle Libre device Exclusion Criteria: * Pre-existing type 1 or type 2 diabetes mellitus * Current preeclampsia or major obstetric complications at enrollment * Major psychiatric disorders interfering with participation * Chronic use of sedatives or anxiolytic medications * Inability to complete questionnaires * Planned delivery outside the study's hospital network * Any condition judged by clinicians to interfere with participation or data reliability
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What it tests

  • Home-Based Glucose Monitoring
  • Inpatient Glucose Monitoring
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Where

1 site
University hospital of Split
Split, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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