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| Name | Class |
|---|---|
| SomaLogic, Inc. | INDUSTRY |
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Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard of Care (uninformed).
Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes.
Secondary Aims:
Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice.
Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment.
Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVD-T2D Informed Medical Management (Informed) | Other | The SomaSignal Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion. |
|
| Standard of Care (Uninformed) | Other | The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) and Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test | Other | The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider. |
| Measure | Description | Time Frame |
|---|---|---|
| The relation of prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) to CVD-T2D test risk assessment in the Informed group vs. Uninformed group. | Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception. | A survey will be obtained from the referring providers to assess perceived impact of the SomaLogic CVD-T2D test on risk. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups. | Cost effectiveness of additional therapies measured by the incremental cost-effectiveness ratio utilizing the projected costs related to changes in prescription rates over the Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life from cardiovascular event rate reductions estimated from the protein predicted risks. The incremental cost-effectiveness ratio is a way of investigating whether an intervention yields sufficient value to justify its cost. We will compare the Informed group to the Uninformed group, and find the difference in average cost, and differences in average effectiveness. The ratio is the incremental cost-effectiveness ratio (ICER). The recommended measure for effectiveness is Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Neeland, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals | Cleveland | Ohio | 44106 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2021 | Dec 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 1 year |
| The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the CVD-T2D and Metabolic Factors test results at the end of the study in the Uninformed group. | Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. | 20 weeks |
| The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the Metabolic Factors test results at the end of the study in the Informed group. | Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. | 20 weeks |
| D004700 | Endocrine System Diseases |