Pregestational DiabetesNCT07269015
CGM Accuracy in Pregnancy Study
A study testing Dexcom One Plus, FreeStyle Libre 2 Plus and Additional Study Procedures in people with Pregestational Diabetes and Continuous Glucose Monitoring, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregestational Diabetes, Continuous Glucose Monitoring
- What is being tested?
- Dexcom One Plus, FreeStyle Libre 2 Plus and Additional Study Procedures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Comorbidities affecting glucose metabolism
- Inability to use CGM devices or perform capillary glucose testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Accuracy of Continuous Glucose Monitoring Systems and Educational Needs in Pregnant Women With Diabetes: A Comparison Between Dexcom One Plus and FreeStyle Libre 2 Plus
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).
Read the detailed description
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.
- Being tested
- Dexcom One Plus, FreeStyle Libre 2 Plus, Additional Study Procedures
- Keywords
- type 2 diabetes, continuous glucose monitoring, pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom One PlusDevice
Worn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application
FreeStyle Libre 2 PlusDevice
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 ProceduresProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Dual Continuous Glucose Monitoring Use | Experimental | All participants will wear two continuous glucose monitoring sensors simultaneously Receives: Device: Dexcom One Plus; Device: FreeStyle Libre 2 Plus; Procedure: Additional Study Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (first study visit)
Secondary outcomes (6)
Mean Absolute Difference (MAD) for glucose <70 mg/dL
|Difference| between paired values.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive both sensors simultaneously
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269015
- Sponsor's protocol ID
- P/25-041
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Driesman AS, Konopka JA, Feder O, Aggarwal V, Schwarzkopf R. Management Principles of Massive Acetabular Bone Loss in Revision Total Hip Arthroplasty A Review of the Literature. Bull Hosp Jt Dis (2013). 2023 Mar;81(1):4-10.
PubMed 36821729Dai J, Liu D, Yin X, Wen X, Cai G, Zheng L. Anisotropic Elastomer Ionomer Composite-Based Strain Sensors: Achieving High Sensitivity and Wide Detection for Human Motion Detection and Wireless Transmission. ACS Sens. 2024 Apr 26;9(4):2156-2165. doi: 10.1021/acssensors.4c00274. Epub 2024 Apr 17.
PubMed 38629405Lin S, Pan X, Meng D, Zhang T. Electric conversion treatment of cobalt-containing wastewater. Water Sci Technol. 2021 Apr;83(8):1973-1986. doi: 10.2166/wst.2021.101.
PubMed 33905366Kawada T. Psychosocial factors and mortality in patients with heart failure. Eur J Heart Fail. 2018 Aug;20(8):1243. doi: 10.1002/ejhf.1208. Epub 2018 Apr 24. No abstract available.
PubMed 29693755Murphy HR, Howgate C, O'Keefe J, Myers J, Morgan M, Coleman MA, Jolly M, Valabhji J, Scott EM, Knighton P, Young B, Lewis-Barned N; National Pregnancy in Diabetes (NPID) advisory group. Characteristics and outcomes of pregnant women with type 1 or type 2 diabetes: a 5-year national population-based cohort study. Lancet Diabetes Endocrinol. 2021 Mar;9(3):153-164. doi: 10.1016/S2213-8587(20)30406-X. Epub 2021 Jan 28.
PubMed 33516295Simmons D, Immanuel J, Hague WM, Teede H, Nolan CJ, Peek MJ, Flack JR, McLean M, Wong V, Hibbert E, Kautzky-Willer A, Harreiter J, Backman H, Gianatti E, Sweeting A, Mohan V, Enticott J, Cheung NW; TOBOGM Research Group. Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. 2023 Jun 8;388(23):2132-2144. doi: 10.1056/NEJMoa2214956. Epub 2023 May 5.
PubMed 37144983
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Continuous Glucose Monitoring Systems and Educational Needs in Pregnant Women With Diabetes: A Comparison Between Dexcom One Plus and FreeStyle Libre 2 Plus
- ClinicalTrials.gov ID
- NCT07269015
- Acronym / sponsor ID
- P/25-041
- Keywords
- type 2 diabetes, continuous glucose monitoring, pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive both sensors simultaneously
| Arm | Type | Receives |
|---|---|---|
| Dual Continuous Glucose Monitoring Use | Experimental | Device: Dexcom One Plus, Device: FreeStyle Libre 2 Plus, Procedure: Additional Study ProceduresAll participants will wear two continuous glucose monitoring sensors simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Comorbidities affecting glucose metabolism
- Inability to use CGM devices or perform capillary glucose testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom One PlusWorn on the upper arm for 10 days Two replacements during the 30-day study period Used with Dexcom mobile application | Device | Dual Continuous Glucose Monitoring Use |
| FreeStyle Libre 2 PlusWorn on the opposite arm for 15 days One replacement during the 30-day study period Used as real-time CGM via LibreLink | Device | Dual Continuous Glucose Monitoring Use |
| Additional Study ProceduresCapillary 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 | Procedure or surgery | Dual Continuous Glucose Monitoring Use |
Primary outcome
Mean Absolute Relative Difference (MARD)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Mean Absolute Difference (MAD) for glucose <70 mg/dL
Time frame: End of 30-day monitoring period
Agreement rates (15/15%, 20/20%, 40/40%) across glucose ranges
Time frame: End of 30-day monitoring period
Dietary habits (Mediterranean diet adherence)
Time frame: Baseline and End of 30-day monitoring period
Physical activity
Time frame: 7 days before baseline and through study completion, an average of 1 week
Sleep quality
Time frame: Baseline and through study completion, an average of 1 week
Patient-reported outcomes (PROMs)
Time frame: Through study completion, an average of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 36821729Driesman AS, Konopka JA, Feder O, Aggarwal V, Schwarzkopf R. Management Principles of Massive Acetabular Bone Loss in Revision Total Hip Arthroplasty A Review of the Literature. Bull Hosp Jt Dis (2013). 2023 Mar;81(1):4-10.
- Background: PubMed 38629405Dai J, Liu D, Yin X, Wen X, Cai G, Zheng L. Anisotropic Elastomer Ionomer Composite-Based Strain Sensors: Achieving High Sensitivity and Wide Detection for Human Motion Detection and Wireless Transmission. ACS Sens. 2024 Apr 26;9(4):2156-2165. doi: 10.1021/acssensors.4c00274. Epub 2024 Apr 17.
- Background: PubMed 33905366Lin S, Pan X, Meng D, Zhang T. Electric conversion treatment of cobalt-containing wastewater. Water Sci Technol. 2021 Apr;83(8):1973-1986. doi: 10.2166/wst.2021.101.
- Background: PubMed 29693755Kawada T. Psychosocial factors and mortality in patients with heart failure. Eur J Heart Fail. 2018 Aug;20(8):1243. doi: 10.1002/ejhf.1208. Epub 2018 Apr 24. No abstract available.
- Background: PubMed 33516295Murphy HR, Howgate C, O'Keefe J, Myers J, Morgan M, Coleman MA, Jolly M, Valabhji J, Scott EM, Knighton P, Young B, Lewis-Barned N; National Pregnancy in Diabetes (NPID) advisory group. Characteristics and outcomes of pregnant women with type 1 or type 2 diabetes: a 5-year national population-based cohort study. Lancet Diabetes Endocrinol. 2021 Mar;9(3):153-164. doi: 10.1016/S2213-8587(20)30406-X. Epub 2021 Jan 28.
- Background: PubMed 37144983Simmons D, Immanuel J, Hague WM, Teede H, Nolan CJ, Peek MJ, Flack JR, McLean M, Wong V, Hibbert E, Kautzky-Willer A, Harreiter J, Backman H, Gianatti E, Sweeting A, Mohan V, Enticott J, Cheung NW; TOBOGM Research Group. Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. 2023 Jun 8;388(23):2132-2144. doi: 10.1056/NEJMoa2214956. Epub 2023 May 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom One Plus, FreeStyle Libre 2 Plus and Additional Study Procedures in people with Pregestational Diabetes and Continuous Glucose Monitoring, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Verónica Perea, MD, PhD (0043937 36 50 50 ext. 11330, vperea@mutuaterrassa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Relative Difference (MARD) (time frame: End of 30-day monitoring period; Primary outcome). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269015, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.