NCT07314944 Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes
| NCT ID | NCT07314944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Split, School of Medicine |
| Condition | Gestational Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-11-01 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT07314944 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314944 currently recruiting?
Yes, NCT07314944 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Split, School of Medicine to inquire about joining.
Where is the NCT07314944 trial being conducted?
This trial is being conducted at Split, Croatia.
Who is sponsoring the NCT07314944 clinical trial?
NCT07314944 is sponsored by University of Split, School of Medicine. The trial plans to enroll 100 participants.
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