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

Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D); Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neda Rasouli, MD; Phone Number: 3037244651; Email: neda.rasouli@cuanschutz.edu
• Study Contact Backup: Name: Aanchal Gupta, MD Candidate-2022; Phone Number: 303-724-1292; Email: aanchal.gupta@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Aanchal Gupta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Provider

• Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes

Inclusion Criteria: Patient

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed); 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); 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.; Other Names: Informed
Placebo Comparator: Group 2: Standard of Care (CVDT2D test, uninformed); 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); 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.; Other Names: Uninformed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in protein predicted risk: SomaLogic CVDT2D test	Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months	Baseline, 6 months
Change in protein predicted risk: biomarkers	Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months	Baseline, 6 months
Standard of care risk assessment: body mass index (BMI) at baseline	Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.	Baseline
Standard of care risk assessment: body mass index (BMI) at 6 months	Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.	6 months
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline	The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.	Baseline
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months	The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.	6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: SomaLogic, Inc.
• Investigators: Principal Investigator: Neda Rasouli, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Proteomics; T2D; CVD
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 21-4510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No