Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of underrepresented minority participants enrolled
研究概览
简要总结
The Stanford Kids CAMP study aims to evaluate the feasibility of enrolling minority participants in school age children (5-13 years old) in a community summer camp setting along with the efficiency by which each participant's biologic specimens are collected. Using remote monitoring technologies and through partnering with community-based organizations, the investigators hypothesize that an increase in underrepresented minority participation in a clinical trial that is greater than the national average is possible.
详细描述
The proposed study is an outpatient prospective, open-label clinical trial comparing 2 groups: Group 1 (aka BAWSI Camp): the Dexcom G6 Pro Continuous Glucose Monitor and the accelerometer and mobile connected device, Group 2 (aka YMCA of Silicon Valley Camp): the Abbott FreeStyle Libre 2 Continuous Glucose Monitor and the accelerometer and mobile connected device. Eligible subjects will be enrolled to each cohort based on their participation in the specific YMCA camp site.
The investigators will study up to 100 minority school-age children (5 - 13 years old) in the San Francisco Bay Area a 5-day summer camp. The study will be split in 2 sequential phases: (A) the BAWSI camp, (B) the YMCA of Silicon Valley camp, following a repeated measures design with the 5-day camp being followed by 5 - 9 days at home, under parental supervision. Study participants will be divided in two equal groups at each site with each wearing the specific manufacturers continuous glucose monitoring device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-13 years of age.
- •Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- •Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
- •A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the monitoring system at home.
排除标准
- •Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason).
- •Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language).
- •Are unable to read, understand or complete informed consent in English or Spanish.
- •Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigators.
结局指标
主要结局
Percentage of underrepresented minority participants enrolled
时间窗: Baseline (prior to arrival at camp)
Percentage of underrepresented minority participants enrolled compared to the U.S. national average.
次要结局
- At-home urine specimen collection(Visit 1, Visit 3 (collected on days 1 and 5))
- Continuous patient monitoring performance(Baseline through Visit 6 (days 1 though 14))
- Duration of initial participant screening(Visit 1 (day 1, up to 60 minutes for screening))
- Report of issues and concerns during at-home monitoring period(Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey))
- Physical activity measured by accelerometry(Baseline through Visit 6 (days 1 through 14))
- Participant perceived use of study technology(Visit 6 (day 14, up to 15 minutes to complete survey))
- Number of patient reported device related issues(Visit 1, Visit 2, Visit 3 (days 1 though 5))
研究者
Karl Sylvester
Associate Dean Maternal Child Health - Research, Professor of Surgery
Stanford University