Clinical trial NCT05380817: Stanford Kids CAMP Study
Official title: Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Obesity
Type-2 Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of underrepresented minority participants enrolled
timeFrame: Baseline (prior to arrival at camp)
Secondary outcomes:
measure: Duration of initial participant screening
timeFrame: Visit 1 (day 1, up to 60 minutes for screening)
measure: Report of issues and concerns during at-home monitoring period
timeFrame: Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)
measure: Physical activity measured by accelerometry
timeFrame: Baseline through Visit 6 (days 1 through 14)
measure: Participant perceived use of study technology
timeFrame: Visit 6 (day 14, up to 15 minutes to complete survey)
measure: At-home urine specimen collection
timeFrame: Visit 1, Visit 3 (collected on days 1 and 5)
measure: Continuous patient monitoring performance
timeFrame: Baseline through Visit 6 (days 1 though 14)
measure: Number of patient reported device related issues
timeFrame: Visit 1, Visit 2, Visit 3 (days 1 though 5)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Karl Sylvester, MD
role: PRINCIPAL_INVESTIGATOR
References: