Clinical trial NCT00248352: A Study Comparing Standard Care for Diabetes to Case-Managed Care for Diabetes in Patients With Coronary Artery Disease
Official title: GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Coronary Disease
Keywords: Coronary Artery Disease
Diabetes Mellitus
Type 2
Chronic Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Pfizer
First posted: 2005-11-03
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Detailed description: Patients with diabetes have a higher incidence of coronary artery disease and a worsened cardiac prognosis. Death from cardiovascular disease accounts for about 70% of all diabetes-related deaths (Booth, 2003). Diabetes is also a common problem among hospitalized cardiac patients. In Ontario, from 1995 to 1997, nearly 1/3 of the 104,471 patients admitted for acute myocardial infarction had diabetes (Booth, 2003). In these patients, hyperglycemia remains a marker for poor outcome despite improvements in coronary care (Wahab, 2002; Capes, 2000).

Several important questions regarding the diabetes care of cardiac patients admitted to hospital wards are yet to be answered. First, it is not known if better glycemic control during the ward phase of hospitalization in itself improves short-term outcomes. Second, assuming that short-term glycemic control is beneficial, it is not known which interventions are effective in accomplishing this. Third, assuming that putting more resources into the management and education of patients with diabetes will translate into long term benefits, it is not known whether this should be done during the "window of opportunity" provided by a cardiac admission or whether this intervention will be more effective if it is deferred until after discharge.

These critical treatment dilemmas have prompted the proposal for the GLUCOSE Pilot Study, a randomized, controlled study to examine the effectiveness of case-managed diabetes care using a multidisciplinary team approach in patients with diabetes admitted to manage concomitant ischemic heart disease. We have designed this protocol to study the effectiveness of case-managed diabetes care by a specialized endocrinology team and compare it to usual care as delivered by the attending cardiologist. Patients will be randomized to specialized endocrinology care or usual care at the time of their admission to the ward. The short-term outcome will be glycemic control of cardiac patients with diabetes while they are admitted to a cardiology ward. In order to compare this with a more typical model of post-discharge care, patients will be re-randomized at the time of discharge into case-managed or usual care groups. The long-term (primary) outcome will be glycemic control and risk factor reduction at 6 months. This factorial design will allow us to compare several treatment models and determine which is the most efficient and effective way to achieve the best long-term diabetes control and risk factor management in our patients.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1C at 6 months post discharge compared to baseline measure obtained at the time of discharge
measure: Change in 10 year cardiac risk as estimated by the UKPDS risk engine at 6 months post discharge compared to baseline measures obtained at time of discharge
Secondary outcomes:
measure: Percentage of patients with capillary blood glucose values within a target range of > 4.0 mmol/L to < 10.0 mmol/L during hospitalization
measure: Number of patients with one or more episodes of hypoglycemia defined as capillary blood glucose measurements < 4.0 mmol/L
measure: Number of patients with one or more episodes of persistent hyperglycemia defined as three consecutive capillary blood glucose measurements > 15.0 mmol/L
measure: Number of patients on prognosis improving medications (ACE inhibitor, ARB, Lipid Lowering Agents)
measure: Number of patients having death, MI, stroke, recurrent ischemic event or readmission to hospital
measure: Length of stay
measure: Risk factor control at 6 months post discharge:
measure: Blood pressure control, defined as percentage of patients within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
measure: Lipid levels within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
measure: Percentage of patients, who were smokers at time of index admission, who have quit
measure: Exercise history
measure: Patient satisfaction with inpatient diabetes management as measured by a standardized questionnaire administered prior to discharge
measure: Diabetes self-care as assessed by questionnaire
measure: Quality of life as assessed by questionnaire
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Instittue
name: Richard F. Davies, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital
name: Janine Malcolm, M.D.
role: PRINCIPAL_INVESTIGATOR
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