Improving cardiovascular risk management in patients with type 2 diabetes
Transform CV Risk in Diabetes
NA · American College of Cardiology · NCT05948969
This study is testing new ways to help doctors better manage heart health for people with type 2 diabetes to see if it improves their overall care and treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American College of Cardiology (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT05948969 on ClinicalTrials.gov |
What this trial studies
This initiative focuses on enhancing the management of cardiovascular risk in patients with type 2 diabetes through a real-world study of physician prescribing patterns and quality improvement strategies. It aims to implement best practices, including clinical decision support and facilitated referrals to a cardiometabolic care team, to ensure the effective use of guideline-directed therapies. The study seeks to evaluate the impact of these interventions on patient outcomes and adherence to treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 2 diabetes who also have a history of atherosclerotic cardiovascular disease.
Not a fit: Patients currently receiving SGLT2 inhibitors or GLP-1 receptor agonists, or those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly reduce cardiovascular risks for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown success in improving cardiovascular outcomes in diabetes management through similar team-based approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Washington, District of Columbia
- Multiple sites nationwide — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Shilpa Patel
- Email: SPatel@acc.org
- Phone: 2023756354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes