Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus (PORTRAIT-DM)

University Hospitals (UH)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05182359

STUDY20211340

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

CVD-T2D Informed Medical Management (Informed)

Other group

Description:

The SomaSignal Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion.

Treatment:

Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test

Standard of Care (Uninformed)

Other group

Description:

The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) and Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion.

Treatment:

Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test