Stanford Kids CAMP Study

Stanford University

Status: Unknown

Conditions: Type-2 Diabetes Mellitus; Pre-diabetes; Obesity

Treatments: Other: Remote Monitoring Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05380817

65748

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BAWSI Group

Other group

Description:

By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children.

Treatment:

Other: Remote Monitoring Program

YMCA of Silicon Valley Group

Other group

Description:

By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children.

Treatment:

Other: Remote Monitoring Program