NCT04905628Unknown不适用
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 发起方
- DexCom, Inc.
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Dexcom Continuous Glucose Monitoring (CGM) System Performance
研究概览
简要总结
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Confirmed pregnancy
- •Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
- •Willing to wear up to the required number of Systems for the total duration of study wear
- •Able to follow study procedures;
- •Able to speak, read, and write in English or Spanish.
排除标准
- •Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
- •Known allergy to medical-grade adhesives
- •Hematocrit outside specification
- •Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
- •Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
- •Currently using Hydroxyurea for treatment
- •Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
结局指标
主要结局
Dexcom Continuous Glucose Monitoring (CGM) System Performance
时间窗: 10 Days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements
次要结局
- System Related Adverse Device Effects(10 Days)
研究者
研究点 (5)
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