PRediction Of Glycemic RESponse Study (PROGRESS)

Scripps Translational Science Institute

Status

Active, not recruiting

Conditions

Glycemic Response

Treatments

Device: Continuous glucose monitoring

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04881019

IRB-20-7635

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,070 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.

Exclusion criteria

Type 1 diabetes mellitus
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