Glycemic Response Clinical Trial
Official title:
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. ;
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