Flash Glucose Monitoring Targets in Gestational Diabetes (FlaG-TaG)

University Medical Centre Ljubljana

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Other: No intervention; Device: Use of FreeStyle Libre 14 day Flash Glucose Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT06774404

0120-449/2021/15

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Pregnant women with GDM using FGM and SMBG

Experimental group

Description:

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

Treatment:

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

Pregnant women with GDM using only SMBG

Active Comparator group

Treatment:

Other: No intervention