- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824277
DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project
Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.
The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 0S8
- Youville Diabetes Center
-
Winnipeg, Manitoba, Canada, R2H 2A6
- I.H. AsperInstitute, St. Boniface General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Able to speak and understand English
- Age > 18
- Able to provide informed consent
- A1C>7%
- Placed on the waiting list for elective cardiac surgery in Manitoba
Exclusion Criteria:
- Progressive cognitive deficit or disease.
- Age < 18
- Unable to provide informed consent
- A1C<7%
- Undergoing emergent cardiac surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Group 1
Group 1 - Standard Pre-operative Diabetes Care
|
|
EXPERIMENTAL: Group 2
Group 2 - Structured Pre-operative Diabetes Optimization
|
Patients will receive structured pre-operative diabetes optimization while they wait for surgery.
Patients will be referred to the Youville Diabetes Center where they will undergo preoperative optimization of their diabetes management.
This will include in-depth diabetes education and instruction pertaining to lifestyle modification (blood glucose monitoring, nutrition, and physical activity) to improve glycemic control.
Pharmacologic therapy will be reviewed by the Youville Diabetes Center certified diabetes nurse educators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in A1C over the study period.
Time Frame: Baseline to the patients' 3-months post-operative appointment
|
Baseline to the patients' 3-months post-operative appointment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes to the responses on the validated patient surveys
Time Frame: Baseline to the patients' 3-months post-operative appointment
|
Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9.
|
Baseline to the patients' 3-months post-operative appointment
|
Changes in the patient perioperative outcomes
Time Frame: Baseline to the patients' 3-months post-operative appointment
|
Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9.
|
Baseline to the patients' 3-months post-operative appointment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sora Ludwig, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRT2012-53
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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