Transform CV Risk in Diabetes

Last updated: July 13, 2023
Sponsor: American College of Cardiology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Prevention

Treatment

Decision support

Facilitated referral to a cardiometabolic team-based center

Clinical Study ID

NCT05948969
Pro00059648
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Current participation in an interventional clinical assessment of an investigationaldrug/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
  • Prior history of diabetic ketoacidosis
  • Pregnancy or active breastfeeding
  • History of Pancreatitis or pancreatic cancer
  • History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: Decision support
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Multiple sites nationwide

    Washington, District of Columbia 20004
    United States

    Active - Recruiting

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