Transform CV Risk in Diabetes (CVRiD)

American College of Cardiology

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Facilitated referral to a cardiometabolic team-based center; Other: Decision support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05948969

Pro00059648

Details and patient eligibility

About

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).

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T2D diagnosis in the medical record

• ASCVD, defined as follows:

  1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
  2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
  3. 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
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Education alone

No Intervention group

Education + decision support to provide suggestions for care optimization

Active Comparator group

Treatment:

Other: Decision support

Education + facilitated referral to cardiometabolic team-based center for care optimization

Active Comparator group

Treatment:

Other: Facilitated referral to a cardiometabolic team-based center