PRediction Of Glycemic RESponse Study (PROGRESS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glycemic Response
• Intervention / Treatment: Device: Continuous glucose monitoring

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1070

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Scripps Research Translational Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 Diabetes; Individuals who have been diagnosed with Type 2 diabetes.	Device: Continuous glucose monitoring; Continuous monitoring of blood sugar over a 10-day period.; Other Names: Dexcom G6
Non type 2 diabetes; Individuals who have not been diagnosed with Type 2 diabetes.	Device: Continuous glucose monitoring; Continuous monitoring of blood sugar over a 10-day period.; Other Names: Dexcom G6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-days

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Collaborators: CareEvolution Healthcare Technology; Tempus AI
• Investigators: Principal Investigator: Edward Ramos, PhD, Scripps Research

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 diabetes
• Other Study ID Numbers: IRB-20-7635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No