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Prediction of Glycemic Response Study (PROGRESS)
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: * 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Scripps Research Translational Institute
San Diego, California, United States
Start Date
June 8, 2021
Primary Completion Date
September 1, 2023
Completion Date
December 31, 2025
Last Updated
May 21, 2025
1,070
ACTUAL participants
Continuous glucose monitoring
DEVICE
Lead Sponsor
Scripps Translational Science Institute
Collaborators
NCT05783752
NCT06005415
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05012046