Clinical Trial

CGM Accuracy in Pregnancy Study

Not Yet Recruiting
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Summary
Pregnancy in women with diabetes remains a high-risk condition, requiring strict glycemic control due to rapid physiological changes that affect insulin sensitivity. Continuous glucose monitoring (CGM) provides detailed glucose trends, but the accuracy of newer, affordable systems such as Dexcom One Plus and FreeStyle Libre 2 Plus has not been evaluated during pregnancy. This prospective interventional study aims to compare the accuracy of these two CGM systems-both worn simultaneously-using capillary glucose as the reference. The study also evaluates educational needs, skills, attitudes, digital competence, lifestyle habits, and patient-reported outcomes among pregnant women with type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes (GDM).
Trial Details
NCT Number NCT07269015
Lead Sponsor Hospital Mutua de Terrassa
Conditions Pregestational Diabetes, Continuous Glucose Monitoring
Enrollment 66 participants
Start Date 2025-12
Primary Completion 2026-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-08