Clinical trial NCT05182359: Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Official title: Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: SomaLogic, Inc.
First posted: 2022-01-10
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 (uninformed).

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception.
timeFrame: 12 weeks
Other outcomes:
measure: Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups.
timeFrame: 1 year
measure: 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.
timeFrame: 20 weeks
measure: 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.
timeFrame: 20 weeks
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Ian Neeland, MD
role: PRINCIPAL_INVESTIGATOR
References: