Cardiovascular Diseases, Diabetes Mellitus, Type 2
Conditions
Keywords
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention
Brief 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.
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.
Interventions
OTHERIntense Education 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.
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Diagnosis of Type 2 diabetes mellitus (T2DM) * History of at least one of the following conditions: 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA) 2. Stroke and/or carotid artery stenosis (≥50%) 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications | Up to 12 Months | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average LDL-C From Baseline to Last Follow-up Visit. | Baseline and last follow-up visit (up to 12 months) | Average change in LDL-C values between baseline visit and last follow-up visit. |
| Number of Participants With LDL-C < 70 mg/dL | Baseline and last follow-up visit (up to 12 months) | Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit. |
| Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Baseline and last follow-up visit (up to 12 months) | Change in systolic and diastolic blood pressure from baseline to last follow-up visit. |
| Number of Participants With sBP < 130 mmHg | Baseline and last follow-up visit (up to 12 months) | Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit |
| Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Up to 12 Months | Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit. |
| Change in Average HbA1c From Baseline to Last Follow-up Visit. | Baseline and last follow-up visit (up to 12 months) | Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit. |
| Number of Participants With HbA1c < 7% | Baseline and last follow-up visit (up to 12 months) | Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit. |
| Number of Participants Experiencing an Event Within 1 Year | Up to 12 Months | Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events. |
| Number of Participants With dBP < 180 mmHg | Baseline and last follow-up visit (up to 12 months) | Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 459 |
| Control Clinics provided with existing clinical care guidelines. | 590 |
| Total | 1,049 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing medication data at 6 and 12 months. | 2 | 2 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 71 years | 70 years |
| Baseline Composite Medication Score 0 points (not taking any recommended medications) | 27 Participants | 57 Participants | 84 Participants |
| Baseline Composite Medication Score 1 point (taking one recommended medication) | 157 Participants | 226 Participants | 383 Participants |
| Baseline Composite Medication Score 2 points (taking two recommended medications) | 275 Participants | 307 Participants | 582 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 38 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 391 Participants | 550 Participants | 941 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 2 Participants | 18 Participants |
| Health Insurance Medicaid only | 34 Participants | 31 Participants | 65 Participants |
| Health Insurance Medicare (alone or with other insurance) | 282 Participants | 410 Participants | 692 Participants |
| Health Insurance No insurance | 11 Participants | 12 Participants | 23 Participants |
| Health Insurance Other insurance only | 18 Participants | 28 Participants | 46 Participants |
| Health Insurance Private only | 114 Participants | 109 Participants | 223 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 10 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 79 Participants | 93 Participants | 172 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants | 4 Participants | 42 Participants |
| Race (NIH/OMB) White | 324 Participants | 477 Participants | 801 Participants |
| Sex: Female, Male Female | 144 Participants | 194 Participants | 338 Participants |
| Sex: Female, Male Male | 315 Participants | 396 Participants | 711 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 459 | 16 / 590 |
| other Total, other adverse events | 4 / 459 | 1 / 590 |
| serious Total, serious adverse events | 3 / 459 | 0 / 590 |
Outcome results
Primary
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%.
Time frame: Up to 12 Months
Population: All participants for whom medication data was available at 6 or 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications | 173 Participants |
| Control | Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications | 85 Participants |
Secondary
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.
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: All participants for whom medication data was available at 6 or 12 months, who had systolic and diastolic blood pressure data at baseline and last follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Baseline systolic blood pressure | 131.40 mmHg | Standard Error 16.14 |
| Intervention | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Follow-up systolic blood pressure | 129.09 mmHg | Standard Error 17.36 |
| Intervention | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Baseline diastolic blood pressure | 74.04 mmHg | Standard Error 10.28 |
| Intervention | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Follow-up diastolic blood pressure | 72.44 mmHg | Standard Error 10.67 |
| Control | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Follow-up diastolic blood pressure | 72.01 mmHg | Standard Error 11.28 |
| Control | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Baseline systolic blood pressure | 129.47 mmHg | Standard Error 16.48 |
| Control | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Baseline diastolic blood pressure | 72.35 mmHg | Standard Error 10.9 |
| Control | Change in Average Blood Pressure From Baseline to Last Follow-up Visit. | Follow-up systolic blood pressure | 130.35 mmHg | Standard Error 17 |
Secondary
Change in Average HbA1c From Baseline to Last Follow-up Visit.
Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: All participants for whom medication data was available at 6 or 12 months, and who had HbA1c values available at baseline and last follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Average HbA1c From Baseline to Last Follow-up Visit. | HbA1c at baseline | 7.64 HbA1c % | Standard Error 1.49 |
| Intervention | Change in Average HbA1c From Baseline to Last Follow-up Visit. | HbA1c at last follow-up visit | 7.47 HbA1c % | Standard Error 1.67 |
| Control | Change in Average HbA1c From Baseline to Last Follow-up Visit. | HbA1c at baseline | 7.50 HbA1c % | Standard Error 1.4 |
| Control | Change in Average HbA1c From Baseline to Last Follow-up Visit. | HbA1c at last follow-up visit | 7.49 HbA1c % | Standard Error 1.43 |
Secondary
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.
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: All participants for whom medication data was available at 6 or 12 months, and who had cholesterol data available at baseline and last follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Average LDL-C From Baseline to Last Follow-up Visit. | Last follow-up visit | 68.79 mg/dL | Standard Error 31.17 |
| Intervention | Change in Average LDL-C From Baseline to Last Follow-up Visit. | Baseline | 72.93 mg/dL | Standard Error 33.7 |
| Control | Change in Average LDL-C From Baseline to Last Follow-up Visit. | Last follow-up visit | 70.60 mg/dL | Standard Error 32.96 |
| Control | Change in Average LDL-C From Baseline to Last Follow-up Visit. | Baseline | 75.07 mg/dL | Standard Error 30.66 |
Secondary
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.
Time frame: Up to 12 Months
Population: All participants for whom medication data was available at 6 or 12 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants Experiencing an Event Within 1 Year | All-cause mortality | 6 participants |
| Intervention | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for stroke | 1 participants |
| Intervention | Number of Participants Experiencing an Event Within 1 Year | Composite (all-cause mortality, MI, stroke, urgent revascularization, decompensated HF) | 23 participants |
| Intervention | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for urgent revascularization | 8 participants |
| Intervention | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for myocardial infarction (MI) | 3 participants |
| Intervention | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for decompensated heart failure (HF) | 8 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for decompensated heart failure (HF) | 18 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | Composite (all-cause mortality, MI, stroke, urgent revascularization, decompensated HF) | 40 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | All-cause mortality | 16 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for myocardial infarction (MI) | 3 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for stroke | 3 participants |
| Control | Number of Participants Experiencing an Event Within 1 Year | Hospitalization for urgent revascularization | 7 participants |
Secondary
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.
Time frame: Up to 12 Months
Population: All participants for whom medication data was available at 6 or 12 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed ACEI or ARB | 372 Participants |
| Intervention | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed 2 or more groups of recommended medications (composite score >= 2) | 361 Participants |
| Intervention | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed SGLT-2i and/or GLP-1RA | 276 Participants |
| Intervention | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed all 3 groups (without metformin monotherapy option) | 142 Participants |
| Intervention | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed high-intensity statin | 323 Participants |
| Control | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed all 3 groups (without metformin monotherapy option) | 50 Participants |
| Control | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed high-intensity statin | 334 Participants |
| Control | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed ACEI or ARB | 402 Participants |
| Control | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed SGLT-2i and/or GLP-1RA | 209 Participants |
| Control | Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit. | Prescribed 2 or more groups of recommended medications (composite score >= 2) | 326 Participants |
Secondary
Number of Participants With dBP < 180 mmHg
Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: Participants with outcome data available at both baseline and last follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With dBP < 180 mmHg | Baseline | 271 participants |
| Intervention | Number of Participants With dBP < 180 mmHg | Last follow-up visit | 267 participants |
| Control | Number of Participants With dBP < 180 mmHg | Last follow-up visit | 355 participants |
| Control | Number of Participants With dBP < 180 mmHg | Baseline | 348 participants |
Secondary
Number of Participants With HbA1c < 7%
Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: Participants with outcome data available at both baseline and last follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With HbA1c < 7% | Baseline | 181 participants |
| Intervention | Number of Participants With HbA1c < 7% | Last follow-up visit | 197 participants |
| Control | Number of Participants With HbA1c < 7% | Baseline | 169 participants |
| Control | Number of Participants With HbA1c < 7% | Last follow-up visit | 167 participants |
Secondary
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.
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: Participants with outcome data available at both baseline and last follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With LDL-C < 70 mg/dL | Baseline | 131 participants |
| Intervention | Number of Participants With LDL-C < 70 mg/dL | Last follow-up visit | 147 participants |
| Control | Number of Participants With LDL-C < 70 mg/dL | Baseline | 111 participants |
| Control | Number of Participants With LDL-C < 70 mg/dL | Last follow-up visit | 126 participants |
Secondary
Number of Participants With sBP < 130 mmHg
Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit
Time frame: Baseline and last follow-up visit (up to 12 months)
Population: Participants with outcome data available at both baseline and last follow-up visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With sBP < 130 mmHg | Baseline | 185 participants |
| Intervention | Number of Participants With sBP < 130 mmHg | Last follow-up visit | 200 participants |
| Control | Number of Participants With sBP < 130 mmHg | Baseline | 243 participants |
| Control | Number of Participants With sBP < 130 mmHg | Last follow-up visit | 252 participants |