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

October 25, 2007 updated by: Ottawa Heart Institute Research Corporation

GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Length of stay
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Sanofi
Pfizer

Investigators

  • Principal Investigator: Richard F. Davies, M.D., University of Ottawa Heart Instittue
  • Principal Investigator: Janine Malcolm, M.D., Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2007

Last Update Submitted That Met QC Criteria

October 25, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glucose 101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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