Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal 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

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

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Home-Based Glucose Monitoring; Other: Inpatient Glucose Monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • University Hospital of Split
    • Contact: Blagoja Markoski, MD; Phone Number: +385 21 556 111; Email: office@kbsplit.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18 years or older with a new diagnosis of gestational diabetes mellitus (GDM) between 24 and 34 weeks of gestation who are receiving routine antenatal care at a tertiary obstetric center. Participants represent a real-world clinical population managed either with short inpatient glucose monitoring or home-based digital monitoring, depending on standard clinical pathways. The study population includes women able to complete questionnaires on sleep, mental health, and lifestyle behaviors and willing to participate until delivery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Home-Based Glucose Monitoring; 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.
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.	Other: Inpatient Glucose Monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Adverse Perinatal Outcome	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.	At delivery/birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality (PSQI Score)	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.	At enrollment (24-34 weeks of gestation)
Anxiety Levels (STAI Score)	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.	At enrollment (24-34 weeks of gestation)
Eating Behaviors (TFEQ Subscales)	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.	At enrollment (24-34 weeks of gestation)
Mean Glucose Level	Average interstitial or capillary glucose level obtained from sensor downloads or hospital measurements.	During the 24-36 hour monitoring period (home or inpatient)

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine
• Collaborators: University Hospital of Split

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Mental Health; Anxiety; Sleep Quality; Eating Behavior; Perinatal Outcomes; Glycemic Control; Gestational Diabetes Mellitus; Lifestyle Factors; Metabolic Markers
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Nervous System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior, Animal; Diabetes, Gestational; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Psychological Well-Being; Motor Activity; Feeding Behavior
• Other Study ID Numbers: 520-03/25-01/206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves sensitive pregnancy-related clinical, psychological, and metabolic data, and current approvals cover analysis only within the research team. De-identified, aggregate data may be shared in publications or upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No