Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications

NCT05166382 | Completed

• 1 other identifier: 21-4510
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about using a proteomic test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients.

Conditions

Type 2 Diabetes; Cardiovascular Diseases

Keywords

Proteomics; T2D; Type 2 diabetes mellitus; CVD

Outcome Measures

Primary Outcomes (2)

• Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline

  Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.

  Baseline

• Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6

  Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.

  6 months

Secondary Outcomes (6)

• Change in protein predicted risk: SomaLogic CVDT2D test

  Baseline, 6 months

• Change in protein predicted risk: biomarkers

  Baseline, 6 months

• Standard of care risk assessment: body mass index (BMI) at baseline

  Baseline

• Standard of care risk assessment: body mass index (BMI) at 6 months

  6 months

• Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline

  Baseline

Study Arms (2)

Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)

EXPERIMENTAL

Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit.

Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)

Group 2: Standard of Care (CVDT2D test, uninformed)

PLACEBO COMPARATOR

Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.

Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)

Interventions

Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) BEHAVIORAL

Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their first research visit.

Also known as: Informed

Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)

Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) BEHAVIORAL

Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their second research visit.

Also known as: Uninformed

Group 2: Standard of Care (CVDT2D test, uninformed)

Eligibility Criteria

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

You may qualify if:

• Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes
• Patients receiving care at a UC Health system
• Age 40 years or older
• Type 2 Diabetes
• Eligible for (per drug label/guidelines) at least one of the following classes: SGLT2i, PCSK9i, GLP-1 RA
• Able to provide consent

You may not qualify if:

• Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment
• Systemic Lupus Erythematous (SLE)\*
• Pregnancy (as determined by self report)
• Intolerance or contraindication for use of both GLP1RA and SGLT2i
• 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
• Samples provided by patients with SLE may fail to produce results or may produce inaccurate results because autoantibodies in the patient plasma may interact with the DNA-based reagents used in the assay

Sponsors & Collaborators

• University of Colorado, Denver: lead
• SomaLogic, Inc.: collaborator

Study Sites (1)

Aanchal Gupta

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Neda Rasouli, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)