Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- MAGE (mean amplitude of glycemic excursions)
研究概览
简要总结
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).
详细描述
This research is using continuous glucose monitoring (CGM) to study changes in blood sugar levels that may occur in youth with cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) who experience a pulmonary exacerbation (PEx), whether admitted to the hospital or seen in clinic. We hypothesize that 1) youth experiencing a PEx will have greater blood sugar changes during the PEx than at least 6 weeks after the PEx , 2) that the changes in blood sugars will be greater during the PEx when compared to CGM data gathered at a baseline visit prior to the PEx (when available), 3) and that blood sugar changes during the PEx will compare with changes in short-term clinical outcomes collected using questionnaires about breathing problems, and that this data will be predictive of the need for additional antibiotics. This study aims to compare CGM measures of change during a PEx with those measured after recovery; to compare CGM measures of change during the PEx to those taken at baseline; and to examine the relationships between these changes and the changes in clinical findings including the need for additional antibiotics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6- 25 years old
- •Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations)
- •access to a smart phone and/or internet connection and the ability to complete remote telehealth visits
排除标准
- •known type 1 or type 2 diabetes, monogenic diabetes
- •critical illness requiring admission to the ICU
- •pregnancy
结局指标
主要结局
MAGE (mean amplitude of glycemic excursions)
时间窗: 14 days
CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
CGM standard deviation
时间窗: 14 days
Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
CGM coefficient of variation
时间窗: 14 days
CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)
次要结局
- Need for additional antibiotics within 28 days following initial treatment(up to 2 years)
- Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire(up to 2 years)
- sputum culture as available from clinical data(up to 2 years)
- Forced expiratory volume at one second (FEV1) at each visit(up to 2 years)
- Chronic Respiratory Infection Symptom Score questionnaire(up to 2 years)
- markers of inflammation when available(up to 2 years)