Gestational Diabetes Mellitus (GDM)FlaG-TaGNCT06774404
Flash Glucose Monitoring Targets in Gestational Diabetes
A study testing Use of FreeStyle Libre 14 day Flash Glucose Monitoring System in people with Gestational Diabetes Mellitus (GDM), run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Use of FreeStyle Libre 14 day Flash Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),
- Agreement with the study protocol and ability to follow the study protocol,
- Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,
- Age between 18 and 40 years.
Who cannot join
- History of bariatric surgery,
- Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,
- Multiple pregnancy,
- Hospitalization for psychiatric illness within the last year,
- First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.
Trial locations and contacts
1 site in 1 country.
About this study
The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Use of FreeStyle Libre 14 day Flash Glucose Monitoring System, No intervention
- Keywords
- Gestational diabetes mellitus, Flash Glucose Monitoring, Pregnancy, FGM
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of FreeStyle Libre 14 day Flash Glucose Monitoring SystemDevice
Women with GDM in the intervention arm will use Flash Glucose Monitoring (FGM) from diagnosis until the end of pregnancy
No interventionOther
Only using SMBG
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with GDM using FGM and SMBG | Experimental | Pregnant women with GDM using Flash Glucose Monitoring (FGM) and Self-Monitoring of Blood Glucose (SMBG) Receives: Device: Use of FreeStyle Libre 14 day Flash Glucose Monitoring System |
| Pregnant women with GDM using only SMBG | Active comparator | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Average Fasting Glucose Concentration: Measured in mmol/L, calculated from fasting blood glucose readings and average Postprandial Glucose Concentration: Measured in mmol/L, based on glucose readings taken 60 minutes after main meals.
Measured: Up to delivery
Secondary outcomes (14)
Mean Glucose (MG) in FSL+ SMBG group
Measured in millimoles per liter (mmol/L), reflecting the average glucose level recorded by the sensor.
Measured: Up to delivery
Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)
Measured in millimoles per liter (mmol/L), representing glycemic variability.
Measured: Up to delivery
Time in Range - TIR (SMBG+FSL group)
Defined as the percentage (%) of time sensor glucose levels fall between 3,5 and 7,8 mmol/l
Measured: Up to delivery
Adherence to the Intervention
Measured as the percentage (%) of completed prescribed self-monitoring and sensor glucose readings relative to the total number of prescribed measurements.
Measured: Up to delivery
Gestational Weight Gain (GWG)
Measured in kilograms (kg), calculated as the difference between pre-pregnancy weight and the last recorded weight before delivery.
Measured: Up to delivery
Mode of Delivery
Categorized into vaginal delivery, assisted vaginal delivery, or cesarean section, and reported as percentages (%) for each category.
Measured: At delivery
Occurrence of Hypertensive Disorders
Reported as a binary outcome (Yes/No), based on clinical diagnosis during pregnancy.
Measured: Up to delivery
Birth Weight
Measured in grams (g), recorded immediately after delivery
Measured: At birth of infant
Large-for-Gestational-Age (LGA) Infant
Defined as birth weight above the 90th percentile for gestational age, reported as a binary outcome (Yes/No).
Measured: At birth of infant
Small-for-Gestational-Age (SGA) Infant
Defined as birth weight below the 10th percentile for gestational age, reported as a binary outcome (Yes/No).
Measured: At birth of infant
Gestational Age at Birth
Measured in completed weeks, based on the interval from the first day of the last menstrual period or ultrasound-confirmed dating.
Measured: At birth of infant
Neonatal Hypoglycemia
Defined as blood glucose levels below 2.6 mmol/L in the first 48 hours of life, reported as a binary outcome (Yes/No).
Measured: At birth of infant
Pregnancy loss
Miscarriage, stillbirth, neonatal death
Measured: <28 days of life
Hyperbilirubinemia
Treated with phototherapy
Measured: Within first 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Dec 2022
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774404
- Sponsor's protocol ID
- 0120-449/2021/15
- Acronym
- FlaG-TaG
- Status last verified
- Oct 2024
- First submitted
- 4 Dec 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flash Glucose Monitoring Targets in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06774404
- Acronym / sponsor ID
- FlaG-TaG / 0120-449/2021/15
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational diabetes mellitus, Flash Glucose Monitoring, Pregnancy, FGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 14 Jan 2025 (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 use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with GDM using FGM and SMBG | Experimental | Device: Use of FreeStyle Libre 14 day Flash Glucose Monitoring SystemPregnant women with GDM using Flash Glucose Monitoring (FGM) and Self-Monitoring of Blood Glucose (SMBG) |
| Pregnant women with GDM using only SMBG | Active comparator | Other: No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),
- Agreement with the study protocol and ability to follow the study protocol,
- Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,
- Age between 18 and 40 years.
Key exclusion criteria (5 listed)
- History of bariatric surgery,
- Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,
- Multiple pregnancy,
- Hospitalization for psychiatric illness within the last year,
- First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.
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 |
|---|---|---|
| Use of FreeStyle Libre 14 day Flash Glucose Monitoring SystemWomen with GDM in the intervention arm will use Flash Glucose Monitoring (FGM) from diagnosis until the end of pregnancy | Device | Pregnant women with GDM using FGM and SMBG |
| No interventionOnly using SMBG | Other | Pregnant women with GDM using only SMBG |
Primary outcome
Glycemic control
Time frame: Up to delivery
Average Fasting Glucose Concentration: Measured in mmol/L, calculated from fasting blood glucose readings and average Postprandial Glucose Concentration: Measured in mmol/L, based on glucose readings taken 60 minutes after main meals.
14 secondary outcomes
Mean Glucose (MG) in FSL+ SMBG group
Time frame: Up to delivery
Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)
Time frame: Up to delivery
Time in Range - TIR (SMBG+FSL group)
Time frame: Up to delivery
Adherence to the Intervention
Time frame: Up to delivery
Gestational Weight Gain (GWG)
Time frame: Up to delivery
Mode of Delivery
Time frame: At delivery
Occurrence of Hypertensive Disorders
Time frame: Up to delivery
Birth Weight
Time frame: At birth of infant
Large-for-Gestational-Age (LGA) Infant
Time frame: At birth of infant
Small-for-Gestational-Age (SGA) Infant
Time frame: At birth of infant
Gestational Age at Birth
Time frame: At birth of infant
Neonatal Hypoglycemia
Time frame: At birth of infant
Pregnancy loss
Time frame: <28 days of life
Hyperbilirubinemia
Time frame: Within first 7 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus (GDM)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of FreeStyle Libre 14 day Flash Glucose Monitoring System in people with Gestational Diabetes Mellitus (GDM), run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Aug 2025. 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Up to delivery). 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 19 Aug 2025.