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Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDNA

Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

NCT05182359•University Hospitals Cleveland Medical Center

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

Age

40 - 89 years

Sex

ALL

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)

Locations (1)

University Hospitals

Cleveland, Ohio, United States

Key Dates

Start Date

January 26, 2022

Primary Completion Date

March 31, 2023

Completion Date

March 31, 2023

Last Updated

May 3, 2023

Enrollment

150

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

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

OTHER

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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