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Completed

NCT Number: NCT06774404

Flash Glucose Monitoring Targets in Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Use of FreeStyle Libre 14 day Flash Glucose Monitoring System

Device

Women with GDM in the intervention arm will use Flash Glucose Monitoring (FGM) from diagnosis until the end of pregnancy

No intervention

Other

Only using SMBG

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Glucose (MG) in FSL+ SMBG group

    Time frame: Up to delivery

    Measured in millimoles per liter (mmol/L), reflecting the average glucose level recorded by the sensor.

  2. Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)

    Time frame: Up to delivery

    Measured in millimoles per liter (mmol/L), representing glycemic variability.

  3. Time in Range - TIR (SMBG+FSL group)

    Time frame: Up to delivery

    Defined as the percentage (%) of time sensor glucose levels fall between 3,5 and 7,8 mmol/l

  4. Adherence to the Intervention

    Time frame: Up to delivery

    Measured as the percentage (%) of completed prescribed self-monitoring and sensor glucose readings relative to the total number of prescribed measurements.

  5. Gestational Weight Gain (GWG)

    Time frame: Up to delivery

    Measured in kilograms (kg), calculated as the difference between pre-pregnancy weight and the last recorded weight before delivery.

  6. Mode of Delivery

    Time frame: At delivery

    Categorized into vaginal delivery, assisted vaginal delivery, or cesarean section, and reported as percentages (%) for each category.

  7. Occurrence of Hypertensive Disorders

    Time frame: Up to delivery

    Reported as a binary outcome (Yes/No), based on clinical diagnosis during pregnancy.

  8. Birth Weight

    Time frame: At birth of infant

    Measured in grams (g), recorded immediately after delivery

  9. Large-for-Gestational-Age (LGA) Infant

    Time frame: At birth of infant

    Defined as birth weight above the 90th percentile for gestational age, reported as a binary outcome (Yes/No).

  10. Small-for-Gestational-Age (SGA) Infant

    Time frame: At birth of infant

    Defined as birth weight below the 10th percentile for gestational age, reported as a binary outcome (Yes/No).

  11. Gestational Age at Birth

    Time frame: At birth of infant

    Measured in completed weeks, based on the interval from the first day of the last menstrual period or ultrasound-confirmed dating.

  12. Neonatal Hypoglycemia

    Time frame: At birth of infant

    Defined as blood glucose levels below 2.6 mmol/L in the first 48 hours of life, reported as a binary outcome (Yes/No).

  13. Pregnancy loss

    Time frame: <28 days of life

    Miscarriage, stillbirth, neonatal death

  14. Hyperbilirubinemia

    Time frame: Within first 7 days of life

    Treated with phototherapy

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: FlaG-TaG

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Aug 19, 2025

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.

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