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Diabetes Mellitus, Type 2COORDINATENCT03936660

A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

A study testing Intense Education Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Duke University at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intense Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,049 participants
Where
44 sitesUnited States
Study dates
25 Jul 2019to 30 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • Diagnosis of Type 2 diabetes mellitus (T2DM)
  • 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)
  • Stroke and/or carotid artery stenosis (≥50%)
  • Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
  • Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization

Who cannot join

  • Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
  • GFR<30 mL/min/1.73m2
  • Already on all guideline-recommended therapies for T2DM and CVD
  • Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Endeavor Medical Research

    Alpena, Michigan, 49707

  • Orlando Heart and Vascular Institute

    Altamonte Springs, Florida, 32714

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska, 99508

  • Emory/Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • The Johns Hopkins University

    Baltimore, Maryland, 21287

  • Grandview Health/Alabama Cardiovascular Group

    Birmingham, Alabama, 35243

  • Riverside Medical Center/Synergy Healthcare

    Bradenton, Florida, 34208

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Advanced Heartcare LLC

    Bridgewater, New Jersey, 08807

  • Kernodle Clinic

    Burlington, North Carolina, 27215

  • Advocate Heart Institute

    Chicago, Illinois, 60657

  • Lennar Foundation/Univ. of Miami

    Coral Gables, Florida, 33146

  • Univ. of Texas Southwestern

    Dallas, Texas, 75390

  • Aurora Denver Cardiology

    Denver, Colorado, 80012

  • Iowa Heart Center

    Des Moines, Iowa, 50266

  • Advanced Heart Care Group/Medicoricium LLC

    Fairview Heights, Illinois, 62208

  • Cardiology Institute of Michigan

    Flint, Michigan, 48507

  • Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch

    Greensboro, North Carolina, 27401

  • Advanced Cardiology Associates

    Greenwood, South Carolina, 29646

  • Hannibal Regional Medical Group

    Hannibal, Missouri, 63401

  • Citrus Cardiology

    Inverness, Florida, 34452

  • Baptist Health Research Institute

    Jacksonville, Florida, 32258

  • New Jersey Heart

    Linden, New Jersey, 07036

  • Garden State Heart Care

    Manalapan, New Jersey, 07726

  • Northwell Health/Lenox Hill Hospital

    Manhasset, New York, 11030

  • Heart Clinic of Louisiana

    Marrero, Louisiana, 70072

  • USA Cardiology

    Mobile, Alabama, 36617

  • Advanced Research for Health Improvement, LLC

    Naples, Florida, 34102

  • Cardiovascular Health Clinic

    Oklahoma City, Oklahoma, 73134

  • Specialty Physicians of Illinois

    Olympia Fields, Illinois, 60461

  • Cardiovascular Inst. of Northwest Florida

    Panama City, Florida, 32401

  • UnityPoint Health Cardiovascular Services

    Peoria, Illinois, 61606

  • Dignity Health/DHMG Specialty Medicine

    Phoenix, Arizona, 85013

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840

  • Cardiovascular Associates of the Delaware Valley

    Sewell, New Jersey, 08080

  • Prairie Cardiovascular Consultants

    Springfield, Illinois, 62701

  • Bayfront Cardiovascular Associates

    St. Petersburg, Florida, 33701

  • Stanford University

    Stanford, California, 94305

  • Lonestar Heart and Vascular

    Tomball, Texas, 77375

  • Interventional Cardiac Consultants

    Trinity, Florida, 34655

  • Blue Coast Cardiology

    Vista, California, 92083

  • ProHealth Care Heart and Vascular

    Waukesha, Wisconsin, 53188

  • Cape Fear Heart Associates

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

Read the detailed description

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 US cardiology clinics to an intervention arm vs. control arm. The clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease.

Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.

Being tested
Intense Education Intervention
Keywords
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intense Education InterventionOther

    Also called 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.

Study groups in NCT03936660
Study groupRoleWhat they receive
ControlNo interventionClinics provided with existing clinical care guidelines.
InterventionActive comparatorClinics 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.
Receives: Other: Intense Education Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c < 7%.

    Measured: Up to 12 Months

Secondary outcomes (9)

  1. Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.

    Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.

    Measured: Up to 12 Months

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

    Average change in LDL-C values between baseline visit and last follow-up visit.

    Measured: Baseline and last follow-up visit (up to 12 months)

  3. Number of Participants With LDL-C < 70 mg/dL

    Change in number of participants with LDL-C < 70 mg/dL at baseline visit vs. last follow-up visit.

    Measured: Baseline and last follow-up visit (up to 12 months)

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

    Change in systolic and diastolic blood pressure from baseline to last follow-up visit.

    Measured: Baseline and last follow-up visit (up to 12 months)

  5. Number of Participants With sBP < 130 mmHg

    Proportion of participants achieving sBP < 130 mmHg at baseline vs. last follow-up visit

    Measured: Baseline and last follow-up visit (up to 12 months)

  6. Number of Participants With dBP < 180 mmHg

    Change in number of participants with dBP < 180 mmHg from baseline to last follow-up visit

    Measured: Baseline and last follow-up visit (up to 12 months)

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

    Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.

    Measured: Baseline and last follow-up visit (up to 12 months)

  8. Number of Participants With HbA1c < 7%

    Change in number of participants with HbA1c < 7% from baseline to last follow-up visit.

    Measured: Baseline and last follow-up visit (up to 12 months)

  9. Number of Participants Experiencing an Event Within 1 Year

    Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.

    Measured: Up to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start25 Jul 2019
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,049 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936660
Sponsor's protocol ID
Pro00101556
Acronym
COORDINATE
Status last verified
Apr 2024
First submitted
1 May 2019
Last updated
21 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available.

    PubMed 26981940

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014.

    PubMed 28545639

  • Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28.

    PubMed 28859942

  • American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.

    PubMed 30559235

  • American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010.

    PubMed 30559236

  • Tannu M, Kaltenbach L, Pagidipati NJ, McGuire DK, Aroda VR, Pop-Busui R, Kondamudi N, Al-Khalidi HR, Lopes RD, Cavender MA, Nelson AJ, Kirk J, Lingvay I, Magwire M, Richardson CR, Webb L, Leyva M, Pandey A, Washington A, Pak J, Gaynor T, Khan W, Weston P, Granger CB, Green J. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial. Circulation. 2024 Jul 16;150(3):180-189. doi: 10.1161/CIRCULATIONAHA.124.068962. Epub 2024 Jun 27.

    PubMed 38934111

  • Pagidipati NJ, Nelson AJ, Kaltenbach LA, Leyva M, McGuire DK, Pop-Busui R, Cavender MA, Aroda VR, Magwire ML, Richardson CR, Lingvay I, Kirk JK, Al-Khalidi HR, Webb L, Gaynor T, Pak J, Senyucel C, Lopes RD, Green JB, Granger CB; COORDINATE-Diabetes Site Investigators. Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1261-1270. doi: 10.1001/jama.2023.2854.

    PubMed 36877177

Questions about this trial

What is this clinical trial studying?

A study testing Intense Education Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Duke University at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications (time frame: Up to 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936660, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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