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

NCT05256706 | Completed Results FDA Device

• 1 other identifier: STUDY00003362
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results

  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 made by physicians to participants, after these test results, will be collected. Medical records will be reviewed to assess any changes in treatment strategies.

  6 months and 12 months after baseline

Secondary Outcomes (13)

• Number of Participants With Changes in the SSCVD Results

  Baseline and 6 months

• Changes in Low-density Lipoprotein (LDL)

  6 months and 12 months

• Changes in High-density Lipoprotein (HDL)

  6 months and 12 months

• Changes in Triglycerides (TG) Levels

  6 months and 12 months

• Changes in Glucose Levels

  6 months and 12 months

Study Arms (2)

SomaSignal Informed Medical Management SSCVD

EXPERIMENTAL

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

Standard of Care (Uninformed Arm)

ACTIVE COMPARATOR

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

Interventions

SomaSignal Informed Medical Management SSCVD DIAGNOSTIC_TEST

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.

Also known as: SSCVD Informed

SomaSignal Informed Medical Management SSCVD

Standard of Care OTHER

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.

Also known as: Uninformed Arm

Standard of Care (Uninformed Arm)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• Emory University: lead
• SomaLogic, Inc.: collaborator

Study Sites (5)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic, Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Arshed Quyyumi
• Organization: Emory University

aquyyum@emory.edu

404-712-2741

Study Officials

• Arshed Quyyumi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 25, 2022
• Study Start: February 3, 2022
• Primary Completion: December 9, 2023
• Study Completion: December 9, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Researchers will share data after completion of the trial and initial data are published.
• Access Criteria: Data will be shared via secured data transfer

Locations

US (5)