NCT04881019

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,070

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 21, 2025

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

May 6, 2021

Last Update Submit

May 15, 2025

Conditions

Glycemic Response

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Type 2 Diabetes

Individuals who have been diagnosed with Type 2 diabetes.

Device: Continuous glucose monitoring

Non type 2 diabetes

Individuals who have not been diagnosed with Type 2 diabetes.

Device: Continuous glucose monitoring

Interventions

Continuous glucose monitoringDEVICE

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

Also known as: Dexcom G6
Non type 2 diabetesType 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 18 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Research Translational Institute

San Diego, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and stool for genetic and microbiome analyses, respectively.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Edward Ramos, PhD

    Scripps Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Digital Clinical Trials

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

June 8, 2021

Primary Completion

September 1, 2023

Study Completion

December 31, 2025

Last Updated

May 21, 2025

Record last verified: 2024-12

Locations

US(1)