An interventional study of Dexcom One Plus and FreeStyle Libre 2 Plus in Pregestational Diabetes and Continuous Glucose Monitoring, sponsored by Hospital Mutua de Terrassa. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Hospital Mutua de Terrassa · Not applicable, Interventional, and Diagnostic
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).
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospital Mutua de Terrassa is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will wear two continuous glucose monitoring sensors simultaneously
Device: Dexcom One Plus · Device: FreeStyle Libre 2 Plus · Procedure: Additional Study Procedures
Worn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application
Worn on the opposite arm for 15 days One replacement during the 30-day study period Used as real-time CGM via LibreLink
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
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
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)
Mean Absolute Difference (MAD) for glucose <70 mg/dL
\|Difference\| between paired values.
Time frame: End of 30-day monitoring period
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
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
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
Sleep quality
Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance. Sleep component scores will be summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Time frame: Baseline and through study completion, an average of 1 week
Patient-reported outcomes (PROMs)
The Glucose Monitoring System Satisfaction Survey (GMSS) will be used to assess patients' satisfaction with their continuous glucose monitoring (CGM) system. GMSS is a 15-item questionnaire with a score range of 1 to 5. Higher scores indicate greater satisfaction.
Time frame: Through study completion, an average of 1 week
Plan to share: No
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Mutua de Terrassa