Continuous Glucose Monitoring in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time spent with glucose <40 mg/dL
研究概览
简要总结
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
详细描述
We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.
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
- 1 Hour 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother at least 18 years of age
- •Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
- •Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers
排除标准
- •Infants born small for gestational age (SGA)
- •Infant birth weight <2.5 kg
- •Infant BMI <10th percentile on Olsen chart
- •Infants born <38 weeks gestation
- •Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
- •Mother is non-English speaking
结局指标
主要结局
Time spent with glucose <40 mg/dL
时间窗: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as \<40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of \<40 mg/dL.
次要结局
未报告次要终点
研究者
Dr Jane Kim
Professor of Pediatrics
University of California, San Diego