Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
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).
Key facts
- Study ID
- NCT05182359
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 150
- Starts
- 2022-01-26
- Expected to finish
- 2023-03-31
- Last updated by the study team
- 2023-05-03
Who can join
Age: 40 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University Hospitals — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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