PRediction Of Glycemic RESponse Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glycemic Response Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Research Translational Institute

San Diego, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring

Device

Continuous monitoring of blood sugar over a 10-day period.

Other names: Dexcom G6

Primary outcomes

Gylcemic response profiles

Time frame: 10-days

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.

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

CareEvolution Healthcare Technology
Tempus AI

Registry information

Official study title

Prediction of Glycemic Response Study (PROGRESS)

Acronym: PROGRESS

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: May 11, 2021
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed