A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Mean absolute relative difference (MARD)
研究概览
简要总结
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.
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
- 24 Hours 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 0-90 days old
- •Gestational Age: > 28 weeks gestational age
- •Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge
排除标准
- •Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
- •Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
- •Infants on hypothermic protocols
- •Infants expected to remain in the NICU <24 hours
- •Infants enrolled in a competing clinical trial
- •Family/team have decided to limit or redirect from aggressive NICU technological support
- •Ward of the state
结局指标
主要结局
Mean absolute relative difference (MARD)
时间窗: Through study completion, about 2 years
Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.
次要结局
- Mean absolute difference (MAD)(Through study completion, about 2 years)