Trial Outcomes & Findings for A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease (NCT NCT00248352)
NCT ID: NCT00248352
Last Updated: 2026-06-22
Results Overview
Outcome is measured by the difference between the baseline (time of discharge) measurement of HbA1C (in mmol/mol) and the measurement of HbA1C (in mmol/mol) at the 6 month follow-up post discharge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
Baseline (time of hospital discharge) to 6months post discharge
Results posted on
2026-06-22
Participant Flow
Participant milestones
| Measure |
Usual Inpatient /Usual Outpatient Diabetes Care
randomized to standard care for inpatient setting at University of Ottawa Heart Institute and after discharge from hospital
|
Case Managed Inpatient/Usual Outpatient Diabetes Care
randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by usual oupatient care after discharge.
|
Usual Inpatient / Case Managed Outpatient Diabetes Care
randomized to standard routine inpatient Diabetes Care followed by outpatient care managed by Nurse Educator, Nutritionist and Diabetologist .
|
Case Managed Inpatient and Outpatient Care
randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by case managed outpatient care for Diabetes by Nurse Educator, Nutritionist and Diabetologist after discharge.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
46
|
44
|
38
|
|
Overall Study
COMPLETED
|
39
|
45
|
44
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Usual Inpatient /Usual Outpatient Diabetes Care
n=41 Participants
randomized to standard care for inpatient setting at University of Ottawa Heart Institute and after discharge from hospital
|
Case Managed Inpatient/Usual Outpatient Diabetes Care
n=46 Participants
randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by usual oupatient care after discharge.
|
Usual Inpatient / Case Managed Outpatient Diabetes Care
n=44 Participants
randomized to standard routine inpatient Diabetes Care followed by outpatient care managed by Nurse Educator, Nutritionist and Diabetologist .
|
Case Managed Inpatient and Outpatient Care
n=38 Participants
randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by case managed outpatient care for Diabetes by Nurse Educator, Nutritionist and Diabetologist after discharge.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
21 Participants
n=6 Participants
|
84 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
17 Participants
n=6 Participants
|
85 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
31 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
30 Participants
n=6 Participants
|
138 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
41 participants
n=20 Participants
|
46 participants
n=20 Participants
|
44 participants
n=40 Participants
|
38 participants
n=6 Participants
|
169 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (time of hospital discharge) to 6months post dischargeOutcome is measured by the difference between the baseline (time of discharge) measurement of HbA1C (in mmol/mol) and the measurement of HbA1C (in mmol/mol) at the 6 month follow-up post discharge.
Outcome measures
| Measure |
Usual Outpatient Diabetes Care Baseline HBA1C ≥ 10
n=6 Participants
|
Case Managed Outpatient Diabetes Care Baseline HBA1C ≥ 10
n=9 Participants
|
Usual Outpatient Diabetes Care Baseline HBA1C < 10
n=58 Participants
|
Case Managed Outpatient Diabetes Care Baseline HBA1C < 10
n=67 Participants
|
|---|---|---|---|---|
|
Change in HbA1C Levels at 6 Months Post Discharge
|
7.583 mmol/mol
Standard Deviation 2.038
|
8.644 mmol/mol
Standard Deviation 1.752
|
7.010 mmol/mol
Standard Deviation 1.356
|
6.360 mmol/mol
Standard Deviation 1.228
|
Adverse Events
Usual Outpatient Diabetes Care
Serious events: 52 serious events
Other events: 18 other events
Deaths: 10 deaths
Case Managed Outpatient Diabetes Care
Serious events: 49 serious events
Other events: 21 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Usual Outpatient Diabetes Care
n=87 participants at risk
Participants receiving the usual care for diabetes management
|
Case Managed Outpatient Diabetes Care
n=82 participants at risk
|
|---|---|---|
|
Cardiac disorders
Death
|
11.5%
10/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
6.1%
5/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Cardiac disorders
Cardiac Admissions
|
34.5%
30/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
26.8%
22/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Metabolism and nutrition disorders
Diabetes related admissions
|
1.1%
1/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
3.7%
3/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Cardiac disorders
Cardiac Emergency room visits
|
35.6%
31/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
23.2%
19/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Metabolism and nutrition disorders
Diabetes Emergency room visits
|
2.3%
2/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
4.9%
4/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Nervous system disorders
Stroke
|
4.6%
4/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
0.00%
0/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.1%
1/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
0.00%
0/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Cardiac disorders
Myocardial Infarction
|
5.7%
5/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
1.2%
1/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Cardiac disorders
Coronary Revascularization
|
10.3%
9/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
9.8%
8/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
17.2%
15/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
36.6%
30/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
Other adverse events
| Measure |
Usual Outpatient Diabetes Care
n=87 participants at risk
Participants receiving the usual care for diabetes management
|
Case Managed Outpatient Diabetes Care
n=82 participants at risk
|
|---|---|---|
|
Eye disorders
Diabetes related eye changes
|
20.7%
18/87 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
25.6%
21/82 • Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C \<10 or \>10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
|
Additional Information
Dr. Richard F. Davies
University of Ottawa Heart Institute
Phone: 613-696-7325
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place