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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Cardiovascular Diseases; Type 2 Diabetes

Treatments: 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

Funder types: Other; Industry

Identifiers

NCT05166382

21-4510

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

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 group

Description:

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

Treatment:

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