PRediction Of Glycemic RESponse Study

Glycemic Response Clinical Trial

— PROGRESS  

Official title:

Prediction of Glycemic Response Study (PROGRESS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881019
• Other study ID #: IRB-20-7635
• Status: Active, not recruiting
• Start date: June 8, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1070
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Response

Intervention

Device:
• Continuous glucose monitoring
Continuous monitoring of blood sugar over a 10-day period.

Locations

Country	Name	City	State
United States	Scripps Research Translational Institute	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	CareEvolution Healthcare Technology, Tempus Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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