CGM Accuracy in Pregnancy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-01-31

Brief Summary

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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).

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Detailed Description

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Women with diabetes during pregnancy experience increased risks of congenital malformations, neonatal morbidity, hypertensive disorders, and abnormal fetal growth. Continuous glucose monitoring (CGM) improves glycemic outcomes in type 1 diabetes (T1D) in pregnancy, yet evidence remains limited for type 2 diabetes (T2D) and gestational diabetes (GDM). Dexcom One Plus and FreeStyle Libre 2 Plus are recent low-cost systems with CE-mark approval for use in pregnancy, both with reported Mean Absolute Relative Difference (MARD) values around 8%. However, neither system has been specifically validated in pregnant populations.

Physiological changes in pregnancy-including increased total body water and interstitial fluid-may alter CGM accuracy. Prior studies show that earlier FreeStyle Libre versions may overestimate hypoglycemia in pregnant women. Furthermore, women with T2D or GDM typically have little prior exposure to diabetes education or CGM technology, which may contribute to suboptimal glycemic control.

This study evaluates the accuracy and usability of Dexcom One Plus and FreeStyle Libre 2 Plus during pregnancy, while also assessing educational and digital literacy needs to optimize CGM implementation in real-world clinical practice.

Conditions

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Pregestational Diabetes Continuous Glucose Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants receive both sensors simultaneously

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dual Continuous Glucose Monitoring Use

All participants will wear two continuous glucose monitoring sensors simultaneously

Group Type EXPERIMENTAL

Dexcom One Plus

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

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

Interventions

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Dexcom One Plus

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

Intervention Type 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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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