Flash Glucose Monitoring Targets in Gestational Diabetes

Last updated: March 25, 2025
Sponsor: University Medical Centre Ljubljana
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Use of FreeStyle Libre 14 day Flash Glucose Monitoring System

No intervention

Clinical Study ID

NCT06774404
0120-449/2021/15
  • Ages 18-40
  • Female

Study 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

Inclusion Criteria:

  1. Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Departmentof 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

Exclusion Criteria:

  1. History of bariatric surgery,

  2. Treatment with systemic corticosteroids for more than 14 days prior to inclusion inthe 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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Use of FreeStyle Libre 14 day Flash Glucose Monitoring System
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • University Medical Centre Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.