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CGM Accuracy in Pregnancy Study
Sponsor: Hospital Mutua de Terrassa
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).
Official title: Evaluation of the Accuracy of Continuous Glucose Monitoring Systems and Educational Needs in Pregnant Women With Diabetes: A Comparison Between Dexcom One Plus and FreeStyle Libre 2 Plus
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-12
Completion Date
2027-01
Last Updated
2025-12-08
Healthy Volunteers
No
Interventions
Dexcom One Plus
Worn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application
FreeStyle Libre 2 Plus
Worn on the opposite arm for 15 days One replacement during the 30-day study period Used as real-time CGM via LibreLink
Additional Study Procedures
Capillary glucose monitoring before meals, 1 hour postprandially, and during symptoms of hypoglycemia (Contour Instant) One baseline structured education session for participants without prior CGM experience Routine diabetes education according to national guidelines
Locations (1)
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain