N/A
N=1,049
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Diabetes Mellitus, Type 2 · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03936660 ↗Enrolled (actual)
1,049
Serious AEs
0.3%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications — 173; 85 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intense Education Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications |
173; 85 | — |
| SECONDARY Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. |
323; 334; 372; 402; 276; 209 | — |
| SECONDARY Change in Average LDL-C From Baseline to Last Follow-up Visit. |
72.93; 75.07; 68.79; 70.60 | — |
| SECONDARY Number of Participants With LDL-C < 70 mg/dL |
131; 111; 147; 126 | — |
| SECONDARY Change in Average Blood Pressure From Baseline to Last Follow-up Visit. |
131.40; 129.47; 129.09; 130.35; 74.04; 72.35 | — |
| SECONDARY Number of Participants With sBP < 130 mmHg |
185; 243; 200; 252 | — |
| SECONDARY Number of Participants With dBP < 180 mmHg |
271; 348; 267; 355 | — |
| SECONDARY Change in Average HbA1c From Baseline to Last Follow-up Visit. |
7.64; 7.50; 7.47; 7.49 | — |
| SECONDARY Number of Participants With HbA1c < 7% |
181; 169; 197; 167 | — |
| SECONDARY Number of Participants Experiencing an Event Within 1 Year |
23; 40; 6; 16; 3; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03936660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.