Gestational DiabetesNCT07314944
Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes
An observational study of Gestational Diabetes, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Home-Based Glucose Monitoring and Inpatient Glucose Monitoring
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2025to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University hospital of Split
Split, 21000
Blagoja Markoski, MD, +385 21 556 111, office@kbsplit.hr
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Home-Based Glucose Monitoring, Inpatient Glucose Monitoring
- Keywords
- Gestational Diabetes Mellitus, Sleep Quality, Anxiety, Mental Health, Eating Behavior, Lifestyle Factors, Physical Activity, Metabolic Markers, Glycemic Control, Perinatal Outcomes
- Medical subject headings
- Diabetes, Gestational, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Psychological Well-Being, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Glucose MonitoringOther
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 MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Inpatient Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery/birth
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: At enrollment (24-34 weeks of gestation)
Mean Glucose Level
Average interstitial or capillary glucose level obtained from sensor downloads or hospital measurements.
Measured: During the 24-36 hour monitoring period (home or inpatient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Nov 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split
- Responsible party
- Principal investigator, Ivana Pavlinac Dodig, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314944
- Sponsor's protocol ID
- 520-03/25-01/206
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07314944
- Acronym / sponsor ID
- 520-03/25-01/206
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes Mellitus, Sleep Quality, Anxiety, Mental Health, Eating Behavior, Lifestyle Factors, Physical Activity, Metabolic Markers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- University Hospital of Split
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Home-Based Digital Monitoring | – | Other: Home-Based Glucose MonitoringPregnant 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. |
| Group 2: Hospital-Based Glucose Monitoring | – | Other: Inpatient Glucose MonitoringPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Glucose MonitoringIntervention 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. | Other | Group 1: Home-Based Digital Monitoring |
| Inpatient Glucose MonitoringParticipants 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. | Other | Group 2: Hospital-Based Glucose Monitoring |
Primary outcome
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.
4 secondary outcomes
Sleep Quality (PSQI Score)
Time frame: At enrollment (24-34 weeks of gestation)
Anxiety Levels (STAI Score)
Time frame: At enrollment (24-34 weeks of gestation)
Eating Behaviors (TFEQ Subscales)
Time frame: At enrollment (24-34 weeks of gestation)
Mean Glucose Level
Time frame: During the 24-36 hour monitoring period (home or inpatient)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Adverse Perinatal Outcome (time frame: At delivery/birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.