Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes
Recruiting · NCT07314944 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- University hospital of Split - Split, Croatia