How sleep, lifestyle, and metabolism relate to pregnancy outcomes in gestational diabetes
Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study
This project will see if sleep quality, anxiety, eating and activity habits, and metabolic markers relate to blood sugar control and birth outcomes in pregnant people with gestational diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Split, School of Medicine Academic / other |
| Locations | 1 site (Split) |
| Trial ID | NCT07314944 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort following pregnant people newly diagnosed with gestational diabetes from diagnosis (24–34 weeks) until delivery. Participants complete validated questionnaires on sleep (PSQI), anxiety (STAI), and eating behavior (TFEQ), and provide routine clinical lab data including glucose, liver enzymes, lipids, and blood counts. Care follows existing clinical pathways at a tertiary obstetric center, with participants receiving either short inpatient capillary glucose monitoring or home-based digital monitoring using the FreeStyle Libre device; monitoring pathway is determined by clinical care, not research assignment. The study links behavioral measures, continuous or capillary glucose data, and metabolic markers to perinatal outcomes such as birth weight, cesarean delivery, and neonatal complications.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18 or older with a new diagnosis of GDM by IADPSG criteria at 24–34 weeks who can consent and complete questionnaires, and those in the home-monitoring pathway must be able to use a smartphone and the FreeStyle Libre device.
Not a fit: People with pre-existing type 1 or type 2 diabetes, current major obstetric complications such as preeclampsia, major psychiatric disorders that interfere with participation, or planned delivery outside the hospital network are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could identify modifiable behavioral or monitoring factors (like poor sleep or monitoring method) associated with worse glucose control or pregnancy outcomes, guiding more personalized care for people with GDM.
How similar studies have performed: Previous observational work has linked poor sleep and anxiety to poorer glucose control and CGM/home-monitoring has been validated in pregnancy, but combining detailed behavioral questionnaires with metabolic markers and real-world monitoring pathway comparisons in a prospective GDM cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Split
- University hospital of Split — Split, Croatia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.