A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With C… (NCT00248352) | Clinical Trial Compass
CompletedNot Applicable
A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease
Canada169 participantsStarted 2005-02
Plain-language summary
The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care.
In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care by the existing diabetes care givers.
Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic educator and a dietician.
Who can participate
Sex
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See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diabetes Mellitus, type 2, as defined by at least one of the following:
* Previous diagnosis of diabetes
* two glucose levels consistent with diabetes (fasting glucose \>7.0 mmol/L or random glucose \>11.0 mmol/L )
* HbA1C \> 6.5% using DCCT standardized methods And
Coronary Disease, as defined by at least one of the following:
* Admitting diagnosis of acute coronary syndrome defined by 2/3 of typical history, enzyme changes, dynamic ECG changes
* Prior history of acute coronary syndrome defined as above
* Previously documented myocardial infarction
* Previous coronary revascularization procedure
* Coronary artery disease defined by coronary angiography
* Exercise or persantine nuclear perfusion imaging positive for ischemia
Exclusion Criteria:
* Refusal to enter the study
* Inability to understand consent forms and provide informed consent
* Anticipated length of non-ICU hospital stay less than 48 hours
* Diabetes Mellitus, type 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1C Levels at 6 Months Post Discharge
Timeframe: Baseline (time of hospital discharge) to 6months post discharge
Trial details
NCT IDNCT00248352
SponsorOttawa Heart Institute Research Corporation