NCT01627184已完成不适用
Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Glycemic Control during Exercise
研究概览
简要总结
The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of diabetes mellitus
排除标准
- •Extensive skin changes/diseases
- •Known allergy to medical adhesives
结局指标
主要结局
Glycemic Control during Exercise
时间窗: multiple months, up to 6
The proportion of time spent in euglycemia zone as well as hypoglycemia zone will be determined from the system glucose readings, particularly during subject's high levels of activity. Longitudinal data analysis methods will be used to assess the within-subject and between-subject effects of the glycemic control for the study population.
次要结局
- System Utility and Usability(multiple months, up to 6)
研究者
研究点 (1)
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