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NCT07269015Not yet recruiting

CGM Accuracy in Pregnancy Study

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

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
66 (estimated)
First submitted
19 Nov 2025
Start date
Dec 2025
Primary completion date
Dec 2026
Lead sponsor
Hospital Mutua de Terrassa
NCT number
NCT07269015

What you commit to

  • Study type: Interventional
  • Planned participants: 66
  • From Dec 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Comorbidities affecting glucose metabolism
  • Inability to use CGM devices or perform capillary glucose testing

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Mutua Terrassa
Coordinator of this site? Confirm its status
TerrassaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.