Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Care Provider)
Masking Description
Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)
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.
Intervention: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) (Behavioral)
Group 2: Standard of Care (CVDT2D test, uninformed)
Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.
Intervention: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) (Behavioral)
Outcomes
Primary Outcomes
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
Time Frame: 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.
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline
Time Frame: 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.
Secondary Outcomes
- Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months(6 months)
- Standard of care risk assessment: body mass index (BMI) at 6 months(6 months)
- Standard of care risk assessment: body mass index (BMI) at baseline(Baseline)
- Change in protein predicted risk: SomaLogic CVDT2D test(Baseline, 6 months)
- Change in protein predicted risk: biomarkers(Baseline, 6 months)
- Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline(Baseline)