CGM Accuracy in Pregnancy Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Mutua de Terrassa
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Comorbidities affecting glucose metabolism
Inability to use CGM devices or perform capillary glucose testing
Trial design
Treatments tested in this trial
- Dexcom One Plus
- FreeStyle Libre 2 Plus
- Additional Study Procedures
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov