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NCT05166382Completed

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
350 (actual)
First submitted
8 Dec 2021
Start date
1 Jan 2022
Primary completion date
1 Jan 2024
Lead sponsor
University of Colorado, Denver
NCT number
NCT05166382

What you commit to

  • Study type: Interventional
  • Participants enrolled: 350
  • From 1 Jan 2022 to the primary completion date, 1 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment
  • 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

Other

  • Systemic Lupus Erythematous (SLE)\*
  • Pregnancy (as determined by self report)
  • Intolerance or contraindication for use of both GLP1RA and SGLT2i

Who the study is looking for

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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aanchal Gupta
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.