Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

NCT05182359 | Completed

• 1 other identifier: STUDY20211340
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception.

  12 weeks

Other Outcomes (3)

• Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups.

  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.

  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.

  20 weeks

Study Arms (2)

CVD-T2D Informed Medical Management (Informed)

OTHER

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

Standard of Care (Uninformed)

OTHER

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

Interventions

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

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.

CVD-T2D Informed Medical Management (Informed); Standard of Care (Uninformed)

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• SomaLogic, Inc.: collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ian Neeland, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UH Center for Cardiovascular Prevention

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 10, 2022
• Study Start: January 26, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

US (1)