SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes

Study Overview
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Brief Summary
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Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to bundle participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.

Detailed Description
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This study is being done to evaluate the use of a new test for the management and treatment of patients who are at high risk of heart disease. The test, called a SomaSignal Test, makes use of personalized proteomics. Proteomes refer to a set of proteins produced in the body. Proteins can affect the function of our bodies and can regulate disease, behavior, and drug treatments. The research team's hypothesis is that the SomaSignal Test can study these proteins and provide results that can help in the management of heart disease. Potential benefits include increased participant engagement and satisfaction from increased personalized medical knowledge and improved participant outcomes through personalized risk stratification, more precise clinical care, and improvements in the triage of medical interventions and education. There may be improved health outcomes in the subset of participants who have a residual risk based on the SomaSignal Test test that they were previously unaware of, and who may receive treatment with a drug or additional lifestyle intervention they were previously eligible for but were not undertaking at the start of the study. All participating providers will be provided education and training on SomaSignal testing including how to interpret and educate participants on the results. There will be two study visits. Participants will be randomized into one of 2 arms. Blood samples and information collected for this study will be shared with SomaLogic Inc., the company where sample testing and analysis will be done.

Official Title
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Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients With Type 2 Diabetes at Higher Risk of Cardiovascular Disease

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Diagnostic Test: SomaSignal Informed Medical Management SSCVD
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants 40 years and older Diagnosis of T2D [according to American Diabetes Association (ADA) guidelines] Able to provide consent Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i Exclusion Criteria: Systemic Lupus Erythematous (SLE) Pregnancy Intolerance or contraindication for use of GLP-1 RA, SGLT2i, and PCSK9i 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 Inability to understand English (currently, SomaSignal testing information, guides, educational materials, and reports are only available in English.)

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SomaSignal Informed Medical Management SSCVD<br>Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will be sent to the providers and participants approximately 2-4 weeks after testing. | Diagnostic Test: SomaSignal Informed Medical Management SSCVD<br>* For participants randomized to the Informed arm, the SSCVD test results will be provided to the participant's clinicians approximately 2-4 weeks after the baseline blood draw. Clinicians will discuss results with the participant and make adjustments to the care plan as needed based on the SSCVD test results within 50 days of receiving results. Clinicians may advise participants to (i) either change the doses of existing medications within existing guidelines, (ii) prescribe additional guideline-based medications, (iii) advise additional lifestyle interventions, or (iv) advise no change. This information will be documented in the case report forms. This test is neither intended to diagnose cardiovascular disease (CVD) nor replace the standard of care protocols for this disease. The physician should not rely solely on this information to make a decision on the best course of action for this patient.<br>* Other names: SSCVD Informed;|
| Active Comparator: Standard of Care (Uninformed Arm)<br>Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will not be provided to the provider or participant until the 6-month visit. | Other: Standard of Care<br>* Clinicians will provide the standard of care based on routine test results and without the SSCVD results. The SSCVD and SomaSignal Metabolic Factor Panel results from participants from both the baseline and 6-month period will be provided to the study team at the 6-month study visit. The SomaSignal Metabolic Factor tests include evaluation of Liver Fat, Glucose Tolerance, Kidney Function, Alcohol Impact, Cardiorespiratory Fitness/oxygen consumption (VO2) max, Resting Energy Rate, Body Fat Percentage, Visceral Fat, and Lean Body Mass. Any recommendations made to the participant by the physicians, based on obtaining the aforementioned test results will be collected.<br>* Other names: Uninformed Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in prescriptions of participants with type 2 diabetes (T2D) in concordance with SSCVD results over a 6-month period | Medical records will be reviewed to evaluate any changes in treatment strategy. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the SSCVD results | Samples for the SSCVD test will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured using laboratory assessments of low-density lipoprotein (LDL) | A blood sample to measure LDL will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured using laboratory assessments of high-density lipoprotein (HDL) | A blood sample to measure HDL will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured using laboratory assessments of triglycerides (TG) | A blood sample to measure TG will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured using laboratory assessments of glucose | A blood sample to measure glucose will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured using laboratory assessments of the Glycated Hemoglobin Test (HbA1C) | A blood sample to measure HbA1C will be drawn during the baseline and follow-up visits. | Baseline and 6 months | 
| Changes in CVD risk factors measured by weight | Weight will be measured in kilograms (kg) during baseline and follow-up visit. | Baseline and 6 months | 
| Changes in CVD risk factors measured by Body Mass Index (BMI) | Height will be measured in meters (m) during the baseline visit, and weight will be measured during the baseline and follow-up visits. BMI will be calculated at each visit using the formula: weight (kg) / [height (m)]^2. | Baseline and 6 months | 
| Changes in CVD risk factors measured using tobacco exposure | A questionnaire asking about personal tobacco use and exposure to second-hand smoke will be provided at baseline and the follow-up visit. Responses are given as categorical, multiple choice options and there is not a summary score calculated for tobacco exposure. | Baseline and 6 months | 
| Changes in CVD risk factors measuring physical activity | A questionnaire will be provided at baseline and follow-up visit asking about physical activity habits. The questionnaire asks respondents how active they are during leisure time and has four response options: Mainly sedentary (e.g. sitting, reading, watching television) Mild exercise, minimal effort (eg. yoga, archery, sport fishing, easy walking at least 3 times per week) Moderate exercise (eg. walking, bicycle riding, or light gardening at least 4 hours per week) Strenuous exercise (heart beats rapidly e.g. running/jogging, football, vigorous swimming at least 3 times per week) A summary score is not calculated for this assessment. | Baseline and 6 months | 
| Changes in CVD risk factors measuring dietary habits | Dietary habits will be assessed with a 5-item asking about consumption of salty foods, deep fried foods, fruits, vegetables, and meat/poultry. Responses are given as yes or no. There is not a summary score generated for this questionnaire. | Baseline and 6 months | 
| Physician Experience Questionnaire | The physician questionnaire will ask 6 to 8 open ended and multiple choice questions regarding changes to treatment plans, identification of unexpected higher risk patients patients, and frequency of testing preferences. There is not a summary score generated for this qualitative questionnaire. | At 6 months | 
| Change in medication possession ratio | Participant adherence to medications will be quantified using the medication possession ratio which is the number of prescriptions filled divided by the number of months participants are prescription eligible. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular risk