DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).

Official Title
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Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project

Conditions
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Diabetes

Intervention / Treatment
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* Other: Structured Pre-operative Diabetes Optimization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>Group 1 - Standard Pre-operative Diabetes Care | |
| Experimental: Group 2<br>Group 2 - Structured Pre-operative Diabetes Optimization | Other: Structured Pre-operative Diabetes Optimization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C over the study period. |  | 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 | 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 | 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 |