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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Croatia
University hospital of Split
RECRUITING
Split
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 100
Treatments
Group 1: Home-Based Digital Monitoring
Pregnant women with GDM who are managed as outpatients using a short (24-36 hour) period of home-based glucose monitoring with the FreeStyle Libre system. This pathway reflects routine clinical practice for women who can return for follow-up the next day and are able to use the digital device.
Group 2: Hospital-Based Glucose Monitoring
Pregnant women with GDM who undergo short (24-hour) inpatient glucose monitoring according to standard hospital protocols. Allocation to this pathway follows clinical logistics (e.g., distance ≥80 km, island residence) and is not assigned by the research team.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital of Split
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov