Using glucose monitoring sensors for managing gestational diabetes
Flash Glucose Monitoring Targets in Gestational Diabetes
This study is testing if using a new glucose monitoring system can help pregnant women with gestational diabetes manage their blood sugar better than just self-monitoring alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06774404 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the FreeStyle Libre 14 day Flash Glucose Monitoring System in pregnant women diagnosed with gestational diabetes mellitus (GDM). It will involve 200 participants who will be randomly assigned to either use the glucose monitoring system alongside traditional self-monitoring of blood glucose or continue with self-monitoring alone. The study aims to evaluate glycemic control, maternal outcomes, and neonatal outcomes to determine if the monitoring system can improve health results for mothers and their babies. The research is being conducted at the University Medical Centre Ljubljana.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 40 diagnosed with gestational diabetes between the 24th and 28th weeks of pregnancy.
Not a fit: Patients with a history of bariatric surgery, multiple pregnancies, or those who have been hospitalized for psychiatric illness within the last year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance glycemic control in pregnant women with GDM, potentially leading to better maternal and neonatal health outcomes.
How similar studies have performed: While smaller studies have shown favorable effects of glucose monitoring in GDM, this approach is still relatively novel and has not been extensively tested in larger populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Klara Zorko, MD
- Email: klara.zorko@kclj.si
- Phone: +386 40 242 733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.