Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05380817
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2022-05-09
Brief Title:
Stanford Kids CAMP Study
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Stanford Kids Continuous Advanced Metabolic Profiling CAMP Study
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 participants 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None