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Behavioral Intervention
Continuous Glucose Monitoring for Prediabetes (G1 Trial)
N/A
Recruiting
Led By David S Black, PhD MPH
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Less than 18 years of age, which is adult in California
Diagnosed with any disorder that interferes with glucose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 days
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to create a new program using a wearable glucose monitor, smartphone feedback, and educational videos to help people with pre-diabetes manage their blood sugar levels better and avoid developing type 2 diabetes
Who is the study for?
This trial is for individuals with prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should be interested in using a wearable glucose monitoring device and engaging with smartphone feedback and educational videos.
What is being tested?
The study tests whether wearing a continuous glucose monitor (CGM) combined with AI-generated smartphone feedback and video clips can help control blood sugar levels in people with prediabetes to prevent the onset of type 2 diabetes.
What are the potential side effects?
While CGMs are generally safe, potential side effects may include skin irritation or allergic reaction at the sensor's insertion site. The intervention is non-invasive, so other typical drug-related side effects are not expected.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I have a condition that affects my blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Glucose levels
Other study objectives
Recorded narrative audio and video archives
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Unmasked CGM feedbackExperimental Treatment1 Intervention
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
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Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,813 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,625 Total Patients Enrolled
David S Black, PhD MPHPrincipal InvestigatorUniversity of Southern California
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