Clinical trial NCT05166382: Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications
Official title: Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Cardiovascular Diseases
Keywords: Proteomics
T2D
Type 2 diabetes mellitus
CVD
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: SomaLogic, Inc.
First posted: 2021-12-21
Enrollment: 350
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline
timeFrame: Baseline
measure: Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Change in protein predicted risk: SomaLogic CVDT2D test
timeFrame: Baseline, 6 months
measure: Change in protein predicted risk: biomarkers
timeFrame: Baseline, 6 months
measure: Standard of care risk assessment: body mass index (BMI) at baseline
timeFrame: Baseline
measure: Standard of care risk assessment: body mass index (BMI) at 6 months
timeFrame: 6 months
measure: Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline
timeFrame: Baseline
measure: Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aanchal Gupta
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Neda Rasouli, MD
role: PRINCIPAL_INVESTIGATOR
References: