NCT06642610已完成不适用
CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 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
研究组 & 干预措施
CF with Prediabetes
Other
a person with cystic fibrosis and prediabetes
干预措施: CGM Dynamic Index (CDI) (Device)
CF without diabetes
Other
a person with cystic fibrosis and no diabetes
干预措施: CGM Dynamic Index (CDI) (Device)
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 (3)
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