How sleep, lifestyle, and metabolism relate to pregnancy outcomes in gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• University hospital of Split
  Split, Croatia Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Continuous glucose monitoring during late pregnancy and after delivery for gestational diabetes

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  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07174245

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.