An observational study in Glycemic Response, sponsored by Scripps Translational Science Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Scripps Translational Science Institute · Observational
The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.
Interested individuals will be directed to download the MyDataHelps™ (CareEvolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. Participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study.
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:
Additional study materials and devices include:
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.
Scripps Translational Science Institute is the lead sponsor of 52 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be composed of 50% individuals with diagnosed T2D (using a validated algorithm) and 50% individuals without a formal diagnosis of T2D and who have a documented HgbA1C \< 6.5 within the prior 2 years, matched to the T2D cohort based on age, gender, and BMI.
Exclusion Criteria:
Individuals who have been diagnosed with Type 2 diabetes.
Device: Continuous glucose monitoring
Individuals who have not been diagnosed with Type 2 diabetes.
Device: Continuous glucose monitoring
Continuous monitoring of blood sugar over a 10-day period.
Also known as: Dexcom G6
Gylcemic response profiles
Distinguish differences in individual glycemic response characteristics as measured by the continuous glucose monitor (mg/dl) and macronutrients (carbohydrates, fats, and proteins) in participants with (n = 500) and without type 2 diabetes (n = 500) matched for age, sex, BMI.
Time frame: 10-days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Scripps Translational Science Institute