Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07314944

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gestational Diabetes Anxiety Disorders Behavior Behavior, Animal Diabetes Mellitus Diabetes, Gestational Dyssomnias Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Motor Activity Nervous System Diseases Nutritional and Metabolic Diseases Personal Satisfaction Pregnancy Complications Psychological Well-Being Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Gestational diabetes mellitus (GDM) is associated with disturbances in glucose regulation as well as a range of behavioral, psychological, and metabolic factors that may contribute to pregnancy outcomes. This prospective observational cohort study follows pregnant women with newly diagnosed GDM to evaluate how sleep quality, anxiety, eating behaviors, physical activity, and metabolic markers relate to glycemic control and perinatal outcomes.

Participants are managed according to standard clinical pathways at a tertiary obstetric center and are allocated either to short inpatient glucose monitoring or to home-based digital monitoring using the FreeStyle Libre system. These pathways reflect real-world clinical indications and are not assigned by the research team. The study leverages this natural variation to compare differences in behavioral, metabolic, and perinatal profiles between groups.

At enrollment, participants complete validated questionnaires assessing sleep quality (PSQI), anxiety (STAI), and eating behaviors (TFEQ). Clinical assessments and laboratory testing include glucose measures, liver enzymes, blood counts, and other metabolic parameters routinely collected in GDM care. Glucose monitoring data are obtained either from inpatient capillary measurements or from downloaded home-based sensor data, depending on the participant's care pathway.

Participants are followed from diagnosis (24-34 weeks of gestation) until delivery. Perinatal outcomes-including birth weight, mode of delivery, neonatal hypoglycemia, and NICU admission-are collected from medical records after delivery. The study analyzes associations between behavioral factors, metabolic markers, and both glycemic and perinatal outcomes. It also evaluates whether differences in the mode of glucose monitoring correspond to differences in maternal psychological well-being or pregnancy outcomes.

This study aims to generate multidimensional insights that may inform more personalized and less burdensome care models for women with GDM, integrating behavioral, metabolic, and clinical information to improve maternal and neonatal health.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-Based Glucose Monitoring

Other

Intervention Description: Home-Based Glucose Monitoring

Participants undergo short-term outpatient glucose monitoring as part of routine GDM care. They follow a written schedule for capillary glucose checks while continuing normal daily activities. Data are reviewed at the follow-up visit, where routine laboratory tests and a fetal ultrasound are also performed. This approach reflects standard outpatient management for women able to return for next-day review.

Inpatient Glucose Monitoring

Other

Participants undergo a 24-hour hospital admission for scheduled capillary glucose measurements using standard hospital glucometers. During admission, participants follow the hospital's predetermined meal plan and receive continuous nursing oversight. A fetal ultrasound and routine laboratory testing are performed during the stay. This pathway follows usual clinical practice for women who require or are assigned inpatient monitoring based on logistical or clinical considerations.

Primary outcomes

  1. Composite Adverse Perinatal Outcome

    Time frame: At delivery/birth

    Proportion of participants experiencing any of the following outcomes in the newborn: macrosomia (birth weight ≥4000 g), neonatal hypoglycemia requiring intervention, admission to neonatal intensive care unit (NICU), 5-minute Apgar score <7, or stillbirth.

Secondary outcomes

  1. Sleep Quality (PSQI Score)

    Time frame: At enrollment (24-34 weeks of gestation)

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-administered questionnaire consisting of 19 items that generate a global score ranging from 0 to 21, as well as seven component (subscale) scores.

    The global PSQI score (range 0-21) and individual component scores will be analyzed as continuous variables. Higher PSQI scores indicate poorer sleep quality, while lower scores reflect better sleep quality.

  2. Anxiety Levels (STAI Score)

    Time frame: At enrollment (24-34 weeks of gestation)

    Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), a validated self-report instrument comprising two 20-item subscales: STAI-State (situational anxiety) and STAI-Trait (general anxiety proneness).

    Each subscale yields a score ranging from 20 to 80, analyzed as a continuous measure. Higher STAI scores indicate greater anxiety, whereas lower scores indicate lower anxiety levels.

  3. Eating Behaviors (TFEQ Subscales)

    Time frame: At enrollment (24-34 weeks of gestation)

    Eating behaviors will be assessed using the Three-Factor Eating Questionnaire (TFEQ), a validated self-report instrument that evaluates three domains of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating.

    Each TFEQ subscale is scored according to the instrument's standard scoring procedure and analyzed as a continuous measure. Higher scores on each subscale indicate a greater degree of the corresponding eating behavior (i.e., greater cognitive restraint, greater uncontrolled eating, or greater emotional eating), whereas lower scores indicate a lesser degree of that behavior.

  4. Mean Glucose Level

    Time frame: During the 24-36 hour monitoring period (home or inpatient)

    Average interstitial or capillary glucose level obtained from sensor downloads or hospital measurements.

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Collaborators

  • University Hospital of Split

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.