Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Not Applicable

Completed

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

• Registration Number: NCT05182359
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Study Start: 2022-01-26
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (Uninformed)	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) 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.
CVD-T2D Informed Medical Management (Informed)	SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States