Status:
COMPLETED
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
SomaLogic, Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-89 years
Phase:
NA
Brief Summary
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 (uninform...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05182359
Start Date
January 26 2022
End Date
March 31 2023
Last Update
May 3 2023
Active Locations (1)
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1
University Hospitals
Cleveland, Ohio, United States, 44106