Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Providers and participants in the uninformed arm will not receive CVD-T2D test results until the second research visit in the study.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
时间窗: 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
时间窗: 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.
次要结局
- Standard of care risk assessment: body mass index (BMI) at baseline(Baseline)
- Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months(6 months)
- Standard of care risk assessment: body mass index (BMI) at 6 months(6 months)
- Change in protein predicted risk: SomaLogic CVDT2D test(Baseline, 6 months)
- Change in protein predicted risk: biomarkers(Baseline, 6 months)
- Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline(Baseline)