Transform CV Risk in Diabetes

RECRUITING

I'm interested ...!!

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).

Conditions:

🦠 Type 2 Diabetes

🗓️ Study Start (Actual) 1 September 2023

🗓️ Primary Completion (Estimated) 1 July 2024

✅ Study Completion (Estimated) 31 December 2024

👥 Enrollment (Estimated) 750

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

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)

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 6 July 2023
First Submitted that Met QC Criteria 13 July 2023
First Posted 17 July 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 13 July 2023
Last Update Posted 17 July 2023
Last Verified July 2023