Health TrialsbyHealthPanel

CGM Accuracy in Pregnancy Study

ConditionsPregestational DiabetesContinuous Glucose Monitoring
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dexcom One Plus

    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

    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

    Procedure/Surgery

    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

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Dual Continuous Glucose Monitoring UseExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Mean Absolute Relative Difference (MARD)

Difference between paired continuous glucose monitoring (CGM) readings (Dexcom One Plus vs. FreeStyle Libre 2 Plus) and reference capillary glucose values.

Time frame
End of 30-day monitoring period; Primary outcome
2

Baseline diabetes knowledge, skills, and attitudes

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.

Time frame
Baseline (first study visit)

Secondary outcomes

1

Mean Absolute Difference (MAD) for glucose <70 mg/dL

\|Difference\| between paired values.

Time frame
End of 30-day monitoring period
2

Agreement rates (15/15%, 20/20%, 40/40%) across glucose ranges

Categories: \<63, 63-140, \<70, 70-180, \>140, \>180 mg/dL.

Time frame
End of 30-day monitoring period
3

Dietary habits (Mediterranean diet adherence)

The Mediterranean Diet Adherence Screener (MEDAS) will be used to evaluate adherence to the Mediterranean diet using a 17-item dietary assessment (score range: 0-17). Higher scores indicate greater adherence to the Mediterranean diet.

Time frame
Baseline and End of 30-day monitoring period
4

Physical activity

Physical activity will be assessed by steps per day (measured as total steps) and using the reduced version of the Pregnancy Physical Activity Questionnaire (PPAQ). The reported time spent in each activity category will be multiplied by the established categorical intensity value (METs) associated with that question. The total weekly physical activity level (MET-minutes/week or MET-hours/week) will be calculated by summing the MET values for each item, allowing for classification by intensity (sedentary, light, moderate, and vigorous)

Time frame
7 days before baseline and through study completion, an average of 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Mutua de Terrassa

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: