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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Split, School of Medicine

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Home-Based Glucose Monitoring
  • Inpatient Glucose Monitoring

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
University hospital of Split21000, Split Croatia

Sponsors and collaborators

University of Split, School of Medicine

Lead sponsor

University Hospital of Split

Collaborator