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A Study Comparing Standard Care for Diabetes to Case-Managed Care for Diabetes in Patients With Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT00248352
Recruitment Status : Completed
First Posted : November 3, 2005
Last Update Posted : October 26, 2007
Sponsor:
Collaborators:
Sanofi
Pfizer
Information provided by:
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE November 1, 2005
First Posted Date  ICMJE November 3, 2005
Last Update Posted Date October 26, 2007
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2006)
  • Change in HbA1C at 6 months post discharge compared to baseline measure obtained at the time of discharge
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
  • • Change in HbA1C at 6 months post discharge compared to baseline measure obtained at the time of discharge
  • • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2006)
  • Percentage of patients with capillary blood glucose values within a target range of > 4.0 mmol/L to < 10.0 mmol/L during hospitalization
  • Number of patients with one or more episodes of hypoglycemia defined as capillary blood glucose measurements < 4.0 mmol/L
  • Number of patients with one or more episodes of persistent hyperglycemia defined as three consecutive capillary blood glucose measurements > 15.0 mmol/L
  • Number of patients on prognosis improving medications (ACE inhibitor, ARB, Lipid Lowering Agents)
  • Number of patients having death, MI, stroke, recurrent ischemic event or readmission to hospital
  • Length of stay
  • Risk factor control at 6 months post discharge:
  • Blood pressure control, defined as percentage of patients within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • Lipid levels within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • Percentage of patients, who were smokers at time of index admission, who have quit
  • Exercise history
  • Patient satisfaction with inpatient diabetes management as measured by a standardized questionnaire administered prior to discharge
  • Diabetes self-care as assessed by questionnaire
  • Quality of life as assessed by questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
  • • Percentage of patients with capillary blood glucose values within a target range of > 4.0 mmol/L to < 10.0 mmol/L during hospitalization
  • • Number of patients with one or more episodes of hypoglycemia defined as capillary blood glucose measurements < 4.0 mmol/L
  • • Number of patients with one or more episodes of persistent hyperglycemia defined as three consecutive capillary blood glucose measurements > 15.0 mmol/L
  • • Number of patients on prognosis improving medications (ACE inhibitor, ARB, Lipid Lowering Agents)
  • • Number of patients having death, MI, stroke, recurrent ischemic event or readmission to hospital
  • • Length of stay
  • • Risk factor control at 6 months post discharge:
  • o Blood pressure control, defined as percentage of patients within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • o Lipid levels within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • o Percentage of patients, who were smokers at time of index admission, who have quit
  • o Exercise history
  • • Patient satisfaction with inpatient diabetes management as measured by a standardized questionnaire administered prior to discharge
  • • Diabetes self-care as assessed by questionnaire
  • • Quality of life as assessed by questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Standard Care for Diabetes to Case-Managed Care for Diabetes in Patients With Coronary Artery Disease
Official Title  ICMJE GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Coronary Disease
Intervention  ICMJE
  • Behavioral: Consultation with Endocrinologist
  • Behavioral: Counseling from Dietician
  • Behavioral: Counseling from Diabetes Educator
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 1, 2005)
212
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248352
Other Study ID Numbers  ICMJE Glucose 101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE
  • Sanofi
  • Pfizer
Investigators  ICMJE
Principal Investigator: Richard F. Davies, M.D. University of Ottawa Heart Instittue
Principal Investigator: Janine Malcolm, M.D. Ottawa Hospital
PRS Account Ottawa Heart Institute Research Corporation
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP