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| Name | Class |
|---|---|
| SomaLogic, Inc. | INDUSTRY |
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The purpose of this study is to learn more about using a proteomic test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed) | Experimental | Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit. |
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| Group 2: Standard of Care (CVDT2D test, uninformed) | Placebo Comparator | Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) | Behavioral | Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their first research visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline | Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported. | Baseline |
| Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6 | Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in protein predicted risk: SomaLogic CVDT2D test | Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months | Baseline, 6 months |
| Change in protein predicted risk: biomarkers |
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Inclusion Criteria: Provider
Inclusion Criteria: Patient
Exclusion Criteria:
Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment
Systemic Lupus Erythematous (SLE)*
Pregnancy (as determined by self report)
Intolerance or contraindication for use of both GLP1RA and SGLT2i
History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
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| Name | Affiliation | Role |
|---|---|---|
| Neda Rasouli, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aanchal Gupta | Aurora | Colorado | 80045 | United States |
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Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.
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Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
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| Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) | Behavioral | Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their second research visit. |
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Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
| Baseline, 6 months |
| Standard of care risk assessment: body mass index (BMI) at baseline | Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. | Baseline |
| Standard of care risk assessment: body mass index (BMI) at 6 months | Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. | 6 months |
| Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline | The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome. | Baseline |
| Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months | The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome. | 6 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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