SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT05256706
- Run by
- Emory University
- People needed
- 143
- Starts
- 2022-02-03
- Expected to finish
- 2023-12-09
- Last updated by the study team
- 2025-01-09
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female participants 40 years and older
- Diagnosis of type 2 diabetes (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
You may not qualify if…
- 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.)
Where it is running
- Grady Health System — Atlanta, Georgia, United States
- Emory Hospital Midtown — Atlanta, Georgia, United States
- Emory Clinic, Emory University Hospital — Atlanta, Georgia, United States
- Emory Hospital — Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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