Cardiovascular Diseases, Type 2 Diabetes
Conditions
Keywords
Proteomics, T2D, Type 2 diabetes mellitus, CVD
Brief summary
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.
Interventions
BEHAVIORALInformed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
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.
BEHAVIORALNot informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
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.
Sponsors
SomaLogic, Inc.
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Masking description
Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Provider * Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes Inclusion Criteria: Patient * Patients receiving care at a UC Health system * Age 40 years or older * Type 2 Diabetes * Eligible for (per drug label/guidelines) at least one of the following classes: SGLT2i, PCSK9i, GLP-1 RA * Able to provide consent
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 * Samples provided by patients with SLE may fail to produce results or may produce inaccurate results because autoantibodies in the patient plasma may interact with the DNA-based reagents used in the assay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline | 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. |
| Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6 | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard of care risk assessment: body mass index (BMI) at baseline | 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. |
| Standard of care risk assessment: body mass index (BMI) at 6 months | 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. |
| Change in protein predicted risk: SomaLogic CVDT2D test | Baseline, 6 months | Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months |
| Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months | 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. |
| Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline | 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. |
| Change in protein predicted risk: biomarkers | Baseline, 6 months | Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months |
Countries
United States
Outcome results
None listed