Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Study Overview
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Brief Summary
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Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard of Care (uninformed).

Detailed Description
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Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes. Secondary Aims: Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice. Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment. Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.

Official Title
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Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving care at a University Hospitals location Patients 40-89 year of age Diagnosis of Type 2 Diabetes Mellitus Eligible for but not currently prescribed a SGLT2i or GLP1RA per drug label. This includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age ≥55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria. Patients that are able to provide consent Exclusion Criteria: Intolerance or contraindication for use of both GLP1RA and SGLT2i Use of SGLT2i or GLP1RA within the 3 months prior to enrollment 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 Patients that have Systemic Lupus Erythematous (SLE) End-stage renal disease Pregnancy (as determined by self-report) Inability to understand English (since must be able to understand risk report which is not translated by the manufacturer)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CVD-T2D Informed Medical Management (Informed)<br>The SomaSignal Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion. | Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test<br>* The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.<br>|
| Other: Standard of Care (Uninformed)<br>The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) and Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion. | Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test<br>* The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation of prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) to CVD-T2D test risk assessment in the Informed group vs. Uninformed group. | Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception. | A survey will be obtained from the referring providers to assess perceived impact of the SomaLogic CVD-T2D test on risk. | 12 weeks |