Flash Glucose Monitoring Targets in Gestational Diabetes

NCT ID: NCT06774404

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-02-01

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pregnant women with GDM using FGM and SMBG

Pregnant women with GDM using Flash Glucose Monitoring (FGM) and Self-Monitoring of Blood Glucose (SMBG)

Group Type: EXPERIMENTAL

Use of FreeStyle Libre 14 day Flash Glucose Monitoring System

Intervention Type: DEVICE

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 only SMBG

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

Only using SMBG

Interventions

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

Intervention Type: DEVICE

No intervention

Only using SMBG

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

0120-449/2021/15

Identifier Type: -

Identifier Source: org_study_id