Clinical trial NCT06774404: Flash Glucose Monitoring Targets in Gestational Diabetes
Official title: Flash Glucose Monitoring Targets in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: Gestational diabetes mellitus
Flash Glucose Monitoring
Pregnancy
FGM
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic control
timeFrame: Up to delivery
Secondary outcomes:
measure: Mean Glucose (MG) in FSL+ SMBG group
timeFrame: Up to delivery
measure: Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)
timeFrame: Up to delivery
measure: Time in Range - TIR (SMBG+FSL group)
timeFrame: Up to delivery
measure: Adherence to the Intervention
timeFrame: Up to delivery
measure: Gestational Weight Gain (GWG)
timeFrame: Up to delivery
measure: Mode of Delivery
timeFrame: At delivery
measure: Occurrence of Hypertensive Disorders
timeFrame: Up to delivery
measure: Birth Weight
timeFrame: At birth of infant
measure: Large-for-Gestational-Age (LGA) Infant
timeFrame: At birth of infant
measure: Small-for-Gestational-Age (SGA) Infant
timeFrame: At birth of infant
measure: Gestational Age at Birth
timeFrame: At birth of infant
measure: Neonatal Hypoglycemia
timeFrame: At birth of infant
measure: Pregnancy loss
timeFrame: <28 days of life
measure: Hyperbilirubinemia
timeFrame: Within first 7 days of life
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: