CGM Accuracy in Pregnancy Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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).

Eligibility

Primary outcome measure(s)

• Mean Absolute Relative Difference (MARD) — End of 30-day monitoring period; Primary outcome
  Difference between paired continuous glucose monitoring (CGM) readings (Dexcom One Plus vs. FreeStyle Libre 2 Plus) and reference capillary glucose values.
• Baseline diabetes knowledge, skills, and attitudes — Baseline (first study visit)
  For the baseline evaluation, a specific questionnaire for the present study was administered, and the Spanish version of the Cambados Questionnaire will also be used. The Cambados Questionnaire is a 5-item questionnaire designed to assess digital competence. The score range is from 0 to 20. Higher scores indicate greater digital competence.

Trial sites (1)

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