Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications

Study Overview
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Brief Summary
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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.

Official Title
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Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study

Conditions
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Cardiovascular Diseases, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
* Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)<br>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. | Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)<br>* 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.<br>* Other names: Informed;|
| Placebo Comparator: Group 2: Standard of Care (CVDT2D test, uninformed)<br>Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period. | Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)<br>* 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.<br>* Other names: Uninformed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteomics, T2D, Type 2 diabetes mellitus, CVD