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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Continuous Glucose Monitoring Use | Experimental | All participants will wear two continuous glucose monitoring sensors simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (first study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Difference (MAD) for glucose <70 mg/dL | |Difference| between paired values. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Verónica Perea, MD, PhD | Contact | 0043937 36 50 50 | 11330 | vperea@mutuaterrassa.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Mutua Terrassa | Terrassa | Barcelona | 08221 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36821729 | Background | 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. | |
| 38629405 | Background | Dai 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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All participants receive both sensors simultaneously
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| 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 | 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 |
|
| 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. | 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) | 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 | 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. | Through study completion, an average of 1 week |
| 33905366 | Background | Lin 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. |
| 29693755 | Background | Kawada 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. |
| 33516295 | Background | Murphy 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. |
| 37144983 | Background | Simmons 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. |
| D004700 | Endocrine System Diseases |