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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
350
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.
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.
Aanchal Gupta
Aurora, Colorado, United States
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.
Time frame: 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.
Time frame: 6 months
Change in protein predicted risk: SomaLogic CVDT2D test
Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months
Time frame: Baseline, 6 months
Change in protein predicted risk: biomarkers
Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
Time frame: 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.
Time frame: Baseline
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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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months