Investigating the Relationship Between Glycemia and Sleep in Adults With Cystic Fibrosis-Related Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Completion Rate
研究概览
简要总结
The goal of this at-home, remote study is to understand the relationship between blood sugars and sleep in adults living with Cystic Fibrosis Related Diabetes (CFRD).
详细描述
The study is a 10-day home-based, observational study of 30 adults with CFRD aimed at concurrently phenotyping glucose, sleep, and circadian rhythms. The remote study is designed to reduce participant burden while allowing for safe and robust objective data and specimen collection and to inform future clinical trial design. The objective of the proposed pilot and feasibility clinical study is to assess the feasibility of remotely phenotyping glycemia, sleep, and circadian rhythms of adults living with CFRD and to generate preliminary data to power a future clinical trial.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or non-pregnant women volunteers (age 18-79) Able and willing to give consent and comply with procedures Known diagnosis of CF Related Diabetes (CFRD) and clinically stable with no significant changes in therapies within the prior 3 months
- •Concomitant Medications:
- •A. No initiation of an investigational drug within prior 28 days B. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within prior 28 days C. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within prior 14 days D. No starting/stopping modulator therapy in the prior 3 months
排除标准
- •Blind, deaf, or unable to speak English Pregnant, nursing, or plan on pregnancy Current use of melatonin and unwilling to stop during the study With skin condition that precludes wearing sensors Within the last 4 weeks, acute CF exacerbation requiring IV antibiotics or hospitalization Major changes in diet or physical activity level in the last 4 weeks Untreated sleep and circadian disorders
结局指标
主要结局
Completion Rate
时间窗: 10 days
Primary feasibility measure, defined by the completion of all study procedures and the return of study devices after the 10-day study period.
次要结局
- Enrollment Rate(Through study completion, an average of 1 year)
- Percentage of time glucose levels(10 days)
- Number of CGM Days(10 days)
- Number of Actigraphy Days(10 days)
- Number of Completed At-Home Kits (HbA1c)(10 days)
- Total number of days with usable food records collected across participants.(10 days)
- Percentage of Time Above Range (>180 mg/dL)(10 days)
- Time Below Range (<54 mg/dL)(10 days)
- Mean Glucose(10 days)
- Glucose Variability(10 days)
- Number of Awakenings(10 days)
- Wake After Sleep Onset (WASO)(10 days)
- Sleep Efficiency(10 days)
- Sleep Latency(10 days)
- Intradaily Stability(10 days)
- Interdaily Variability(10 days)
- Daily Energy Intake(4 days)
- Healthy Eating Index(4 days)
研究者
Hassan Dashti
Assistant Professor
Massachusetts General Hospital