NCT06642610招募中不适用
CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
研究概览
简要总结
The primary objective of this pilot study is to develop a CGM-based model to predict the progression from prediabetes to diabetes in individuals with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CF individuals aged 12-55 years.
- •CF without diabetes or with prediabetes (as defined by OGTT and HbA1c).
- •Willing to use a continuous glucose monitoring system with compatible smart phone for glucose data collection.
- •A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.
排除标准
- •Pregnancy.
- •History of transplant.
- •Use of immunosuppressant drugs.
- •Use of oral steroids or any medication known to interfere with glucose.
- •Allergy to adhesives.
- •Individuals with severe concurrent medical conditions that could confound glucose monitoring data (e.g., terminal illness, major organ failure).
- •Conditions that may make unsafe for participants to do study or impair or confound the study at the discretion of the investigator
结局指标
主要结局
CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
时间窗: 10 days
Estimating the "optimal" cut-offs of the CDI marker, to distinguish between CF groups
次要结局
未报告次要终点
研究者
Viral N. Shah
Professor of Medicine
Indiana University
研究点 (2)
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