Clinical trial NCT04881019: PRediction Of Glycemic RESponse Study
Official title: Prediction of Glycemic Response Study (PROGRESS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glycemic Response
Keywords: Type 2 diabetes
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: CareEvolution Healthcare Technology
name: Tempus AI
First posted: 2021-05-11
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gylcemic response profiles
timeFrame: 10-days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Research Translational Institute
state: California
Study officials:
affiliation: Scripps Research
name: Edward Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References: