Transform CV Risk in Diabetes

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Facilitated referral to a cardiometabolic team-based center; Other: Decision support

• Registration Number: NCT05948969
• Lead Sponsor: American College of Cardiology

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Study Start: 2023-09-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education + facilitated referral to cardiometabolic team-based center for care optimization	Facilitated referral to a cardiometabolic team-based center	-
Education + decision support to provide suggestions for care optimization	Decision support	-

Primary Outcome Measures

Name	Time	Method
New prescription of a SGLT2i and/or GLP-1RA	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)

Trial Locations

Locations (1)

Multiple sites nationwide; 🇺🇸 Washington, District of Columbia, United States