NCT06774404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 19, 2025

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

December 4, 2024

Last Update Submit

August 18, 2025

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational diabetes mellitusFlash Glucose MonitoringPregnancyFGM

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to delivery

Secondary Outcomes (14)

  • Mean Glucose (MG) in FSL+ SMBG group

    Up to delivery

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

    Up to delivery

  • Time in Range - TIR (SMBG+FSL group)

    Up to delivery

  • Adherence to the Intervention

    Up to delivery

  • Gestational Weight Gain (GWG)

    Up to delivery

  • +9 more secondary outcomes

Study Arms (2)

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)

Device: Use of FreeStyle Libre 14 day Flash Glucose Monitoring System

Pregnant women with GDM using only SMBG

ACTIVE COMPARATOR
Other: No intervention

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

Pregnant women with GDM using FGM and SMBG
No interventionOTHER

Only using SMBG

Pregnant women with GDM using only SMBG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of bariatric surgery,
  • Multiple pregnancy,
  • Hospitalization for psychiatric illness within the last year,
  • First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

January 14, 2025

Study Start

December 1, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

August 19, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)