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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CVD-T2D Informed Medical Management (Informed); 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.	Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test; The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.
Other: Standard of Care (Uninformed); 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.	Other: SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test; The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception.	A survey will be obtained from the referring providers to assess perceived impact of the SomaLogic CVD-T2D test on risk.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups.	Cost effectiveness of additional therapies measured by the incremental cost-effectiveness ratio utilizing the projected costs related to changes in prescription rates over the Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life from cardiovascular event rate reductions estimated from the protein predicted risks. The incremental cost-effectiveness ratio is a way of investigating whether an intervention yields sufficient value to justify its cost. We will compare the Informed group to the Uninformed group, and find the difference in average cost, and differences in average effectiveness. The ratio is the incremental cost-effectiveness ratio (ICER). The recommended measure for effectiveness is Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life.	1 year
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.	Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications.	20 weeks
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.	Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications.	20 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: SomaLogic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: STUDY20211340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No