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CGM Accuracy in Pregnancy Study

NCT07269015 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-12-08

No results posted yet for this study

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).

Conditions

  • Pregestational Diabetes
  • Continuous Glucose Monitoring

Interventions

DEVICE

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

DEVICE

Dexcom One Plus

Worn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application

PROCEDURE

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

Sponsors & Collaborators

  • Hospital Mutua de Terrassa

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269015 on ClinicalTrials.gov