PRediction Of Glycemic RESponse Study

NCT ID: NCT04881019

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1070 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-08

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glycemic Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 Diabetes

Individuals who have been diagnosed with Type 2 diabetes.

Continuous glucose monitoring

Intervention Type DEVICE

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

Non type 2 diabetes

Individuals who have not been diagnosed with Type 2 diabetes.

Continuous glucose monitoring

Intervention Type DEVICE

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

Interventions

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Continuous glucose monitoring

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

Intervention Type DEVICE

Other Intervention Names

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Dexcom G6

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CareEvolution Healthcare Technology

UNKNOWN

Sponsor Role collaborator

Tempus AI

INDUSTRY

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Ed Ramos

Director, Digital Clinical Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward Ramos, PhD

Role: PRINCIPAL_INVESTIGATOR

Scripps Research

Locations

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Scripps Research Translational Institute

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-20-7635

Identifier Type: -

Identifier Source: org_study_id

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