Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
研究概览
简要总结
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.
详细描述
The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis
- •≥ 10 years of age
- •Fluency in written and spoken English as the GTT@Home is currently only available in English
排除标准
- •Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
- •Major medical or psychiatric disorders other than CF
- •Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, >2g acetaminophen per day)
- •History of severe adhesive reactions that may lead to an inability to tolerate CGM wear
结局指标
主要结局
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
时间窗: 2 hour mark in OGTT
Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
次要结局
- Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose.(Up to 2 hours)
- Difference between plasma glucose and CGM measured glucose after the fasting glucose(Up to 20 minutes after the fasting glucose)
- Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT.(Up to 20 minutes after the 2 hour mark in the OGTT)
- Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD.(Within 2 weeks after removal of the CGM)
- The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team(Up to 2 hours)
- Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT.(Up to 20 minutes after the 1 hour mark in the OGTT)
- Perceived benefits and burdens of CGM use(Within 2 weeks after removal of the CGM)