Type 2 Diabetes Clinical Trial
— PORTRAIT-DMOfficial title:
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Verified date | May 2023 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 150 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 89 Years |
Eligibility | Inclusion Criteria: - Patients receiving care at a University Hospitals location - Patients 40-89 year of age - Diagnosis of Type 2 Diabetes Mellitus - Eligible for but not currently prescribed a SGLT2i or GLP1RA per drug label. This includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age =55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria. - Patients that are able to provide consent Exclusion Criteria: - Intolerance or contraindication for use of both GLP1RA and SGLT2i - Use of SGLT2i or GLP1RA 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 - Patients that have Systemic Lupus Erythematous (SLE) - End-stage renal disease - Pregnancy (as determined by self-report) - Inability to understand English (since must be able to understand risk report which is not translated by the manufacturer) |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | SomaLogic, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 1 year | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Secondary | 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 |
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