Cardiovascular Risk Management for Type 2 Diabetes

(CVRiD Trial)

Not currently recruiting at 1 trial location

Overseen By Jack Reilly

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American College of Cardiology

Must not be taking: SGLT2i, GLP-1RA

Disqualifiers: Type 1 diabetes, Pregnancy, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health in people with type 2 diabetes by testing methods to help doctors make better treatment decisions. Participants will receive either educational resources alone, education with decision support (a tool to aid doctors in making treatment choices), or education plus a referral to a specialized care team. It targets individuals with type 2 diabetes who have heart or blood vessel problems, such as past heart attacks or strokes. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance treatment strategies for heart health in type 2 diabetes patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are currently taking SGLT2i or GLP-1RA medications.

What prior data suggests that these methods are safe for cardiovascular risk management in type 2 diabetes?

Research has shown that clinical decision support tools (CDSTs) are generally safe and can improve certain aspects of care quality in preventing heart disease. In studies, these tools helped doctors make better decisions for heart health without causing serious side effects.

Studies suggest that referring patients to a cardiometabolic team-based center can effectively manage heart health and diabetes. This method involves a team of specialists working together and has reduced heart-related risks for people with type 2 diabetes. Like decision support tools, this referral approach focuses on improving care without introducing new drugs or treatments that might cause side effects.

Both methods aim to enhance care and involve minimal risk by focusing on how care is provided rather than introducing new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on innovative ways to manage cardiovascular risks for individuals with type 2 diabetes. Unlike traditional methods that rely heavily on medications or lifestyle changes alone, this trial explores decision support systems that offer personalized care suggestions, enhancing the ability to optimize treatment plans. Additionally, facilitated referrals to a specialized cardiometabolic team-based center aim to integrate care more effectively, potentially leading to better health outcomes. By shifting the focus to a more integrated and personalized approach, these methods could revolutionize how cardiovascular risks are managed in people with type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for managing cardiovascular risk in type 2 diabetes?

This trial will compare different approaches to cardiovascular risk management for individuals with type 2 diabetes. Participants in one arm will receive education alone. Another arm will include education plus decision support, which research has shown can improve health outcomes by assisting doctors in managing patients' cholesterol and blood pressure. Additionally, over 80% of doctors believe that computerized decision support systems (CDSS) tools lead to better patient outcomes.

In a separate arm, participants will receive education plus facilitated referral to a cardiometabolic team-based center. Research suggests this method greatly reduces the risk of heart and blood vessel problems. In one study, patients using this team-based care approach had a 40.6% lower risk of such complications. This method brings together various health experts to offer more personalized care, benefiting people with type 2 diabetes who are at high risk for heart issues. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who have a history of cardiovascular issues like stroke, artery disease, or heart problems. They must not be on certain diabetes medications (SGLT2i or GLP-1RA), have severe liver disease, pancreatitis, cancer, less than a year to live, or be pregnant/breastfeeding.

Inclusion Criteria

I have a history of heart disease, including heart attack or procedures to open my heart's arteries.

I have had artery disease in my legs, including treatments to improve blood flow.

I have had a stroke, TIA, or surgery to open my neck arteries.

Exclusion Criteria

I have a history of medullary thyroid cancer or MEN-2.

You are currently taking part in a study testing a new drug or medical device, except for studies related to COVID-19.

You have had a heart transplant or have plans to get a ventricular assist device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Decision Support

Participants receive education and decision support to optimize care

9 months

Follow-up

Participants are monitored for new prescriptions of SGLT2i and/or GLP-1RA

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision support
• Facilitated referral to a cardiometabolic team-based center

Trial Overview The study tests how decision support tools and referrals to specialized cardiometabolic care can improve the use of treatments that lower heart risk in people with type 2 diabetes. It's about finding best practices in real-world medical settings.

How Is the Trial Designed?

Group I: Education alone Active Control 1 Intervention

Group II: Education + decision support to provide suggestions for care optimization Active Control 1 Intervention

Group III: Education + facilitated referral to cardiometabolic team-based center for care optimization Active Control 1 Intervention

Who Is Running the Clinical Trial?

American College of Cardiology

Lead Sponsor

Trials

18

Recruited

312,000+

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6558725/

The effect of computerized decision support systems on ... Among CVRM patients, the results tended towards a beneficial effect of CDSS, but only LDL-c target attainment in diabetes patients reached ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838316

Mobile App–Based Intervention and Cardiovascular Risk ... Main Outcomes and Measures The primary outcome included mean changes in hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), and ...

3. diabetesjournals.org diabetesjournals.org/care/article/33/2/258/27084/Cost-Effectiveness-of-the-Diabetes-Care-Protocol-a

Cost-Effectiveness of the Diabetes Care Protocol, a ... After 1 year, DCP results in reduced blood pressure, total cholesterol, and estimated 10-year UKPDS CHD risk in comparison with usual care. This resulted in a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266666772400223X

Do clinical decision support tools improve quality of care ... This study suggests CDSTs are effective in enhancing a limited number of quality of care outcomes in primary CVD prevention.

5. mdpi.com mdpi.com/2077-0383/14/7/2170

The Effectiveness of an Electronic Decision Support ... Additionally, Zhang et al. demonstrated that more than 80% of physicians believe that the use of a CDSS can help improve type 2 diabetes patient outcomes, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6452802/

Cardiovascular risks in type 2 diabetes and the ... Patients with type 2 diabetes (T2D) are at increased cardiovascular (CV) risk compared to subjects without diabetes.

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001040

Comprehensive Management of Cardiovascular Risk ... For adults with T2D, a tailored nutrition plan is a key component for cardiovascular risk reduction, and a heart-healthy dietary pattern is ...

8. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S207/157549/10-Cardiovascular-Disease-and-Risk-Management

10. Cardiovascular Disease and Risk Management A recent systematic review and meta-analysis of nine trials enrolling 11,005 participants with type 2 diabetes reported that intensive blood ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10966415/

Shared Decision-Making in Cardiovascular Risk Factor ... This systematic review and meta-analysis examines the use and outcomes of shared decision-making in interventions to enhance management of cardiovascular risk ...