Pre-diabetesNCT05380817
Stanford Kids CAMP Study
A study testing Remote Monitoring Program in people with Pre-diabetes and Obesity, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Obesity, Type-2 Diabetes Mellitus
- What is being tested?
- Remote Monitoring Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Stanford, California, 94305
Grant S Wells, MS, 650-723-7632, gwells2@stanford.edu
About this study
Official title: Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study
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.
Read the 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.
- Conditions
- Pre-diabetes, Obesity, Type-2 Diabetes Mellitus
- Being tested
- Remote Monitoring Program
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring ProgramOther
Participants receive remote monitoring while engaging in a theory-based, multi-component, multi-level, multi-setting (MMM) community team sports program designed specifically for children
| Study group | Role | What they receive |
|---|---|---|
| BAWSI Group | Other | By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children. Receives: Other: Remote Monitoring Program |
| YMCA of Silicon Valley Group | Other | By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children. Receives: Other: Remote Monitoring Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of underrepresented minority participants enrolled
Percentage of underrepresented minority participants enrolled compared to the U.S. national average.
Measured: Baseline (prior to arrival at camp)
Secondary outcomes (7)
Duration of initial participant screening
Average duration of time to screen enrolled subjects on Day 1 of summer camp.
Measured: Visit 1 (day 1, up to 60 minutes for screening)
Report of issues and concerns during at-home monitoring period
# of telephone reported incidents and questions during at-home monitoring period.
Measured: Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)
Physical activity measured by accelerometry
Garmin Vivofit 4 total and after camp physical activity and sedentary behavior
Measured: Baseline through Visit 6 (days 1 through 14)
Participant perceived use of study technology
Percentage of survey responses
Measured: Visit 6 (day 14, up to 15 minutes to complete survey)
At-home urine specimen collection
Percentage of enrolled participants who complete at home urine sample collection and bring the sample with them to camp.
Measured: Visit 1, Visit 3 (collected on days 1 and 5)
Continuous patient monitoring performance
Percentage of total study time children were monitored using glucose and accelerometry devices
Measured: Baseline through Visit 6 (days 1 though 14)
Number of patient reported device related issues
This measure is intended to evaluate study device performance during summer camp
Measured: Visit 1, Visit 2, Visit 3 (days 1 though 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Sylvester, Stanford University
- Investigators
- Karl Sylvester, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380817
- Sponsor's protocol ID
- 65748
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators can request the limited public access data set from the Stanford Metabolic Health Center's Data Coordinating Center
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study
- ClinicalTrials.gov ID
- NCT05380817
- Acronym / sponsor ID
- 65748
- Conditions
- Pre-diabetes, Obesity, Type-2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAWSI Group | Other | Other: Remote Monitoring ProgramBy partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children. |
| YMCA of Silicon Valley Group | Other | Other: Remote Monitoring ProgramBy partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Monitoring ProgramParticipants receive remote monitoring while engaging in a theory-based, multi-component, multi-level, multi-setting (MMM) community team sports program designed specifically for children | Other | BAWSI Group, YMCA of Silicon Valley Group |
Primary outcome
Percentage of underrepresented minority participants enrolled
Time frame: Baseline (prior to arrival at camp)
Percentage of underrepresented minority participants enrolled compared to the U.S. national average.
7 secondary outcomes
Duration of initial participant screening
Time frame: Visit 1 (day 1, up to 60 minutes for screening)
Report of issues and concerns during at-home monitoring period
Time frame: Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)
Physical activity measured by accelerometry
Time frame: Baseline through Visit 6 (days 1 through 14)
Participant perceived use of study technology
Time frame: Visit 6 (day 14, up to 15 minutes to complete survey)
At-home urine specimen collection
Time frame: Visit 1, Visit 3 (collected on days 1 and 5)
Continuous patient monitoring performance
Time frame: Baseline through Visit 6 (days 1 though 14)
Number of patient reported device related issues
Time frame: Visit 1, Visit 2, Visit 3 (days 1 though 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Yes. Investigators can request the limited public access data set from the Stanford Metabolic Health Center's Data Coordinating Center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Sylvester, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring Program in people with Pre-diabetes and Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grant S Wells, MS ((650) 723-7632, gwells2@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of underrepresented minority participants enrolled (time frame: Baseline (prior to arrival at camp)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.