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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
D4C Trial 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.Check my eligibility
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.See study design
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.
D4C Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
CVD risk score
Cost-effectiveness
HbA1C
+3 moreD4C 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.
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Who is running the clinical trial?
Xiamen Ophthalmology Center Affiliated to Xiamen UniversityOTHER
22 Previous Clinical Trials
188,400 Total Patients Enrolled
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
215,370 Total Patients Enrolled
2 Trials studying Diabetes
8,242 Patients Enrolled for Diabetes
Xiamen UniversityOTHER
22 Previous Clinical Trials
190,582 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate to severe heart failure, are receiving hemodialysis, or cannot take metformin or statin medications.Men or women who are 50 years old or older and get their main healthcare from the clinics taking part in the study.Your diabetes is not well controlled, and you have other risk factors for heart disease, or you have a history of certain heart or blood vessel problems.
Research Study Groups:
This trial has the following groups:- Group 1: Protocol-based Integrated Care
- Group 2: Enhanced Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still being accepted to participate in this experiment?
"According to clinicaltrials.gov, the recruitment for this particular trial has closed; it was first posted on October 26th 2016 and last updated September 19th 2022. However, there are still 2356 other studies actively looking for participants at present."
Answered by AI
What are the intended objectives of this evaluation?
"This 18 month clinical trial is evaluating the Incidence of composite major cardiovascular disease events as its primary outcome. Additionally, researchers will be studying changes in HbA1C levels and BP while also assessing cost-effectiveness with an Incremental Cost-Effectiveness Ratio."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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