PRediction Of Glycemic RESponse Study

Study Overview
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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.

Official Title
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Prediction of Glycemic Response Study (PROGRESS)

Conditions
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Glycemic Response

Intervention / Treatment
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* Device: Continuous glucose monitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetes<br>Individuals who have been diagnosed with Type 2 diabetes. | Device: Continuous glucose monitoring<br>* Continuous monitoring of blood sugar over a 10-day period.<br>* Other names: Dexcom G6;|
| Non type 2 diabetes<br>Individuals who have not been diagnosed with Type 2 diabetes. | Device: Continuous glucose monitoring<br>* Continuous monitoring of blood sugar over a 10-day period.<br>* Other names: Dexcom G6;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes