Transform CV Risk in Diabetes

American College of Cardiology1 site in 1 country750 target enrollmentSeptember 1, 2023

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: American College of Cardiology
Enrollment: 750
Locations: 1
Primary Endpoint: New prescription of a SGLT2i and/or GLP-1RA
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

American College of Cardiology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•T2D diagnosis in the medical record
•ASCVD, defined as follows:
•Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
•Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
•Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization

Exclusion Criteria

•Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
•Currently receiving any SGLT2i or GLP-1RA
•Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
•Currently receiving comfort care or enrolled in hospice
•Life expectancy \<1 year
•History of or plan for heart transplantation or ventricular assist device
•Current or planned hemodialysis
•Decompensated end stage liver disease
•History of Fournier's Gangrene
•Type 1 diabetes

Outcomes

Primary Outcomes

New prescription of a SGLT2i and/or GLP-1RA

Time Frame: 9 months

Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)