Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248352
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2005-11-01
Brief Title:
A Study Comparing Standard Care for Diabetes to Case-Managed Care for Diabetes in Patients With Coronary Artery Disease
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
GLUCOSE Glucose Lowering by Usual Care Or Specialized Endocrinology Team
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 13 of the 104471 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None