← Back to Search

Integrated Diabetes Care for Cardiovascular Disease Risk Management (D4C Trial)

N/A

Waitlist Available

Research Sponsored by Tulane University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a protocol-based, integrated approach to care can improve cardiovascular disease risk factors and reduce major cardiovascular events, compared to usual care, in patients with type 2 diabetes and additional risk factors or clinical CVD.

Who is the study for?

This trial is for men and women over 50 with uncontrolled diabetes (HbA1C ≥7%) and additional cardiovascular risk factors or clinical CVD, who are not pregnant, can be followed for 36 months, can give consent, and have no heart failure requiring intense treatment or contraindications to common diabetes medications.

What is being tested?

The D4C Trial is testing if a protocol-based integrated care approach improves cardiovascular disease risk factors in diabetic patients over 18 months and reduces major CVD events over three years compared to usual care in community clinics in Xiamen, China.

What are the potential side effects?

Since the intervention involves standard medical protocols rather than new drugs, side effects may include those commonly associated with typical diabetes and cardiovascular treatments such as metformin or statins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in HbA1C, SBP, and LDL between intervention and control groups, simultaneously modeled using a scaled marginal model which allows estimation of a single overall treatment effect and combined control rate of HbA1c, SBP, and LDL

Incidence of composite major cardiovascular disease events

Secondary study objectives

CVD risk score

Cost-effectiveness

HbA1C

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Protocol-based Integrated CareExperimental Treatment1 Intervention

The protocol-based integrated care, which will provide a standardized, combined, multi-component intervention according to clinical guideline treatment algorithms for diabetes and comorbidities in community clinics, will be delivered by care team (trained primary care physicians, health managers, and nurses supported by diabetes specialists) and assisted by a clinical decision support systems.

Group II: Enhanced ControlActive Control1 Intervention

A usual team-based care delivered by trained primary care physicians, health managers, and nurses supported by diabetes specialists.

Do I qualify?Apply below to find out