Comparing the Accuracy of Two Glucose Sensors in Pregnant Women With Diabetes
Compares two wearable glucose sensors, worn together, in pregnant women with diabetes.
Plain-language title generated from the registry record
Registry title: CGM Accuracy in Pregnancy Study
Key facts
- Where
- Terrassa, SpainSee the site
Where in Spain
- Hospital Universitari Mutua TerrassaTerrassa, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Mutua de Terrassa
- Trial code
- NCT07269015
- Record updated
- 8 December 2025
- Original description
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.Read full original descriptionShow less
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
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).
Inclusion: Pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes, diagnosed before 32 weeks of gestation; Age ≥18 years; Willingness to wear two CGM systems simultaneously; Possession of a smartphone compatible with LibreLink; Ability to sign informed consent.
Exclusion: Comorbidities affecting glucose metabolism; Inability to use CGM devices or perform capillary glucose testing.