Accuracy of Dexcom G6 After Radiation Exposure-A Cross Sectional and Longitudinal Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %)
研究概览
简要总结
A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.
详细描述
To determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the G6 transmitter in the post TPIAT in-patient population.
Reduce burden for patients to remove and waste a functional and expensive Dexcom G6 CGM for radiologic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
This study is not blinded
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned TPIAT at CCHMC
- •Staying in-patient at CCHMC post TPIAT
- •Planned to receive a Dexcom G6 CGM
排除标准
- •Hemo- or peritoneal dialysis
结局指标
主要结局
Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %)
时间窗: 3 months
Blood Glucose levels (mg/dL) obtained by the Dexcom G6 sensor and transmitter compared to blood glucose levels (mg/dL) obtained by a handheld glucometer until the transmitter is changed. The Clarke Error Grid Analysis method was used to compare absolute values. Accuracy reported as percentage of comparators in Zone A and B.
Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %)
时间窗: 3 months
Transmitter functional duration is determined by time from TPIAT procedure and CGM placement (baseline) to time for Transmitter changed (approximately 3 months), Functionality is determined by analysis of Blood Glucose (mg/dL) in month groupings (0-1month, 1-2months, 2+ months from baseline. Blood Glucose levels (mg/dL) obtained by the Dexcom G6 sensor and transmitter compared to blood glucose levels (mg/dL) obtained by a handheld glucometer until the transmitter is changed. The Clarke Error Grid Analysis method was used to compare absolute values. Accuracy reported as percentage of comparators in Zone A and B.
次要结局
未报告次要终点
研究者
Deborah Elder
ASSOCIATE PROFESSOR
Children's Hospital Medical Center, Cincinnati