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Impact of SomaSignal Tests on the choice of glucose-lowering medications: An Adaptive Implementation Study

Study category: Diabetes & Hormone Disorders

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Description

This study plans to learn more about using a protein based test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients. The SomaSignal CVD-T2D Test is a specialized blood test that measures the levels of 27 different proteins in your blood and uses the results to help predict your risk of cardiovascular events over the next few years. Providers will be randomized into informed and uninformed groups with their enrolled patients being put into the same group. Patients will be asked to attend 2 research visits along with 2 normally scheduled standard of care visits with their provider. Patients and providers in the informed group will receive CVD-T2D test results before their standard of care visits while those in the uninformed group will not receive results until the end of the study.

Details
Age

Adult

Eligibility

Provider inclusion criteria: -Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes Patient inclusion criteria -Patients receiving care at UC Health system -Age 40 years or older -Type 2 Diabetes -Eligible for (per drug label/guidelines) at least one of the following drug classes: SGLT2i, PCSK9i, GLP-1 RA but not currently prescribed any of these classes of drugs -Able to provide consent Patient exclusion criteria -Use of SGLT2i or GLP1RA within 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

Type of Study

Diagnostic

Location

Outpatient CTRC

Principal Investigator
Neda Rasouli,  MD

Neda Rasouli, MD

Study ID

Protocol Number: 21-4510

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