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

NCT07314944 | Recruiting

• 1 other identifier: 520-03/25-01/206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes Mellitus; Sleep Quality; Anxiety; Mental Health; Eating Behavior; Lifestyle Factors; Physical Activity; Metabolic Markers; Glycemic Control; Perinatal Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sleep Quality (PSQI Score)

  At enrollment (24-34 weeks of gestation)

• Anxiety Levels (STAI Score)

  At enrollment (24-34 weeks of gestation)

• Eating Behaviors (TFEQ Subscales)

  At enrollment (24-34 weeks of gestation)

• Mean Glucose Level

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

Study Arms (2)

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

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

Interventions

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.

Group 1: Home-Based Digital Monitoring

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.

Group 2: Hospital-Based Glucose Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: collaborator
• University of Split, School of Medicine: lead

Study Sites (1)

University hospital of Split

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Psychological Well-Being; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior; Behavior, Animal

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 2, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)