NCT06774404

Flash Glucose Monitoring Targets in Gestational Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
DEVICE	Use of FreeStyle Libre 14 day Flash Glucose Monitoring System	Women with GDM in the intervention arm will use Flash Glucose Monitoring (FGM) from diagnosis until the end of pregnancy
OTHER	No intervention	Only using SMBG

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2025-01-14
• Last updated: 2025-08-19

Locations

1 site across 1 country: Slovenia

Regulatory

• FDA-regulated device study