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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Baseline diabetes knowledge, skills, and attitudes
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Comorbidities affecting glucose metabolism
- •Inability to use CGM devices or perform capillary glucose testing
结局指标
主要结局
Baseline diabetes knowledge, skills, and attitudes
时间窗: 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.
Mean Absolute Relative Difference (MARD)
时间窗: 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.
次要结局
- Dietary habits (Mediterranean diet adherence)(Baseline and End of 30-day monitoring period)
- Sleep quality(Baseline and through study completion, an average of 1 week)
- Patient-reported outcomes (PROMs)(Through study completion, an average of 1 week)
- Mean Absolute Difference (MAD) for glucose <70 mg/dL(End of 30-day monitoring period)
- Agreement rates (15/15%, 20/20%, 40/40%) across glucose ranges(End of 30-day monitoring period)
- Physical activity(7 days before baseline and through study completion, an average of 1 week)