Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CareEvolution Healthcare Technology | UNKNOWN |
| Tempus AI | INDUSTRY |
Not provided
Not provided
Not provided
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.
Interested individuals will be directed to download the MyDataHelpsâ„¢ (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:
Additional study materials and devices include:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes | Individuals who have been diagnosed with Type 2 diabetes. |
| |
| Non type 2 diabetes | Individuals who have not been diagnosed with Type 2 diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Continuous monitoring of blood sugar over a 10-day period. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward Ramos, PhD | Scripps Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Research Translational Institute | San Diego | California | 92037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Saliva and stool for genetic and microbiome analyses, respectively.
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |