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

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Type 2 Diabetes
• Interventions: 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)

• Registration Number: NCT05166382
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)	Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)	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.
Group 2: Standard of Care (CVDT2D test, uninformed)	Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)	Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.

Primary Outcome Measures

Name	Time	Method
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6	6 months	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.
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Standard of care risk assessment: body mass index (BMI) at baseline	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.
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months	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.
Standard of care risk assessment: body mass index (BMI) at 6 months	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.
Change in protein predicted risk: SomaLogic CVDT2D test	Baseline, 6 months	Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months
Change in protein predicted risk: biomarkers	Baseline, 6 months	Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline	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.

Trial Locations

Locations (1)

Aanchal Gupta; 🇺🇸 Aurora, Colorado, United States