Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1070 participants
OBSERVATIONAL
2021-06-08
2025-12-31
Brief Summary
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Detailed Description
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Once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. This biosamples kit will include:
* Salivary kit for genomics analysis
* Gut microbiome kit
* Home micro-puncture single-use blood collection
Additional study materials and devices include:
* A wrist-worn activity, heart rate and sleep monitor.
* A Dexcom 6 continuous glucose monitor (CGM) and application kit
* A standardized snack bar meal (2 per fasting days)
Participants will be asked to track various digital health measures including their continuous glucose as well as record their meals for a 10-day period. The data connections approved by the participants will continue in the following years.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Type 2 Diabetes
Individuals who have been diagnosed with Type 2 diabetes.
Continuous glucose monitoring
Continuous monitoring of blood sugar over a 10-day period.
Non type 2 diabetes
Individuals who have not been diagnosed with Type 2 diabetes.
Continuous glucose monitoring
Continuous monitoring of blood sugar over a 10-day period.
Interventions
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Continuous glucose monitoring
Continuous monitoring of blood sugar over a 10-day period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to participate in or comply with any of the testing modules asked during the study
* Currently pregnant
* Prior bariatric surgery
* Chemotherapy or radiation treatment for cancer in the past year
* Inflammatory bowel disease
* Known skin allergy to adhesives and nickel (or other contraindications to continuous glucose monitoring)
* Currently taking any oral steroids(these medications may impact glucose levels)
* Antibiotic use in the last 3 months prior to the start of the study or planned use during the duration of the study
* Non-dietary, supplemental probiotic use either daily or weekly
* Hospice care
* End stage renal disease
18 Years
ALL
Yes
Sponsors
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CareEvolution Healthcare Technology
UNKNOWN
Tempus AI
INDUSTRY
Scripps Translational Science Institute
OTHER
Responsible Party
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Ed Ramos
Director, Digital Clinical Trials
Principal Investigators
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Edward Ramos, PhD
Role: PRINCIPAL_INVESTIGATOR
Scripps Research
Locations
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Scripps Research Translational Institute
San Diego, California, United States
Countries
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Other Identifiers
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IRB-20-7635
Identifier Type: -
Identifier Source: org_study_id
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