Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications
Type 2 Diabetes, Cardiovascular Diseases
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Proteomics, T2D, Type 2 diabetes mellitus, CVD
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
Sites / Locations
- Aanchal Gupta
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)
Group 2: Standard of Care (CVDT2D test, uninformed)
Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit.
Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.