Flash Glucose Monitoring Targets in Gestational Diabetes

University Medical Centre Ljubljana205 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

205

Conditions

Gestational Diabetes Mellitus (GDM)

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM), 2. Agreement with the study protocol and ability to follow the study protocol, 3. Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy, 4. Age between 18 and 40 years. Exclusion Criteria: 1. History of bariatric surgery, 2. Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study, 3. Multiple pregnancy, 4. Hospitalization for psychiatric illness within the last year, 5. First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.

Locations (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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.

Time frame: Up to delivery

Secondary Outcomes

Mean Glucose (MG) in FSL+ SMBG group

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

Time frame: Up to delivery

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

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Up to delivery

Mode of Delivery

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

Time frame: At delivery

Occurrence of Hypertensive Disorders

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

Time frame: Up to delivery

Birth Weight

Measured in grams (g), recorded immediately after delivery