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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05166382
• Other study ID #: 21-4510
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aanchal Gupta	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	SomaLogic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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