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

Study Summary

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.

Primary Outcome

The number of participants with type 2 diabetes (T2D) who had changes in prescriptions aligned with SSCVD results at baseline will be reported for the informed group. For the uninformed group, this represents the number of participants who had prescription changes, even though the healthcare provider (HCP) was not informed of the results. SSCVD results from participants at both the baseline and 6-month periods will be provided to the study team during the 6-month study visit. Any recommendations

Conditions Studied

Interventions

• OTHER Standard of Care
• DIAGNOSTIC_TEST SomaSignal Informed Medical Management SSCVD

Study Locations (5)