What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulphonylureas, insulin, and lifestyle interventions. Metformin is generally well-tolerated but can cause gastrointestinal issues like diarrhea and nausea. Sulphonylureas may lead to hypoglycemia and weight gain. Insulin therapy can also cause hypoglycemia and weight gain, along with injection site reactions. Lifestyle interventions, such as diet and exercise, typically have fewer side effects but may be challenging to maintain long-term. Educational interventions aim to optimize these treatments and improve patient outcomes by enhancing provider knowledge and management strategies.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes that also offer cardiovascular benefits, similar to those studied in clinic-level educational interventions. Notable among these are Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitors, such as canagliflozin and empagliflozin, which have shown reductions in cardiovascular events. Another important class is Glucagon-Like Peptide-1 (GLP-1) receptor agonists, including liraglutide and semaglutide, which also demonstrate cardiovascular benefits. These drugs not only help in managing blood glucose levels but also contribute to improved cardiovascular outcomes, making them relevant to the trial's focus on enhancing provider education for better management of Type 2 Diabetes and cardiovascular disease.

What other types of research exist?

Promising alternatives to clinic-level educational interventions for managing Type 2 Diabetes Mellitus and cardiovascular disease include: 1) Lifestyle interventions such as diet modifications and physical activity, which have been shown to reduce cardiovascular risk. 2) Online patient education programs, which offer flexibility and accessibility for patients. 3) High-intensity group and individual education sessions, which have demonstrated efficacy in improving glycemic control. 4) Physician-targeted education programs, which can optimize glycemic management through adherence to treatment guidelines.

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Behavioural Intervention

Intensive Education for Managing Type 2 Diabetes and Cardiovascular Disease (COORDINATE Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes include lifestyle modifications, educational interventions, insulin therapy, and oral hypoglycemic agents. Lifestyle modifications, such as diet and physical activity, help improve insulin sensitivity and reduce cardiovascular risk. Educational interventions aim to enhance patient adherence to treatment plans and self-management strategies, leading to better glycemic control and reduced complications. Insulin therapy and oral hypoglycemic agents work by increasing insulin levels or improving the body's response to insulin. These treatments are crucial for Type 2 Diabetes patients as they help manage blood glucose levels, prevent complications, and improve overall quality of life.

N/A

Waitlist Available

Led By Christopher Granger, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of at least one of the following conditions: Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)

Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)

Must not have

Already on all guideline-recommended therapies for T2DM and CVD

GFR<30 mL/min/1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an educational program for healthcare providers to improve care for patients with type 2 diabetes and heart disease by enhancing teamwork and following best practices.

Who is the study for?

Adults over 18 with Type 2 Diabetes and a history of cardiovascular disease, such as heart attacks, strokes, or poor circulation in limbs. They must be able to understand the study and give consent. People can't join if they have severe kidney issues (GFR<30), are on all recommended treatments for their conditions, or aren't expected to survive/follow-up for at least a year.

What is being tested?

The trial is testing an intense educational program designed to improve treatment management for patients with Type 2 Diabetes who also have cardiovascular disease. Clinics are randomly chosen to either use this new education approach or continue usual care.

What are the potential side effects?

Since this is an educational intervention rather than a drug treatment, there may not be direct side effects like those seen with medication. However, changes in diabetes management could lead to low blood sugar levels or other adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of heart disease, including a heart attack, surgery to improve blood flow to the heart, or blocked arteries.

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I have poor circulation in my legs, confirmed by tests or past surgeries.

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I have had heart disease, stroke, or poor blood flow in my legs.

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I have been diagnosed with Type 2 diabetes.

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I am 18 years old or older.

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I have had a stroke or my carotid artery is more than half blocked.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on all recommended treatments for type 2 diabetes and heart disease.

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My kidney function is low (GFR under 30).

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I cannot take standard treatments for type 2 diabetes and heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications

Secondary study objectives

Change in Average Blood Pressure From Baseline to Last Follow-up Visit.

Change in Average HbA1c From Baseline to Last Follow-up Visit.

Change in Average LDL-C From Baseline to Last Follow-up Visit.

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Clinics provided with existing clinical care guidelines.

Group II: InterventionActive Control1 Intervention

Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes include lifestyle modifications, educational interventions, insulin therapy, and oral hypoglycemic agents. Lifestyle modifications, such as diet and physical activity, help improve insulin sensitivity and reduce cardiovascular risk. Educational interventions aim to enhance patient adherence to treatment plans and self-management strategies, leading to better glycemic control and reduced complications. Insulin therapy and oral hypoglycemic agents work by increasing insulin levels or improving the body's response to insulin. These treatments are crucial for Type 2 Diabetes patients as they help manage blood glucose levels, prevent complications, and improve overall quality of life.

Multicomponent approaches to promoting healthy behaviours in people with Type 2 diabetes: an integrative review.Observational study evaluating the effectiveness of physician-targeted education for improving glycemic management of patients with type 2 diabetes (BEYOND II).Efficacy of lifestyle interventions in patients with type 2 diabetes: A systematic review and meta-analysis.