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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Structured Pre-operative Diabetes Optimization

• Registration Number: NCT01824277
• Lead Sponsor: Dr. Rakesh C. Arora

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2013-03-31
• Study First Submitted QC: 2013-03-31
• Study First Posted: 2013-04-04
• Study Start: 2013-10
• Primary Completion: 2015-12
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Structured Pre-operative Diabetes Optimization	Group 2 - Structured Pre-operative Diabetes Optimization

Primary Outcome Measures

Name	Time	Method
Change in A1C over the study period.	Baseline to the patients' 3-months post-operative appointment

Secondary Outcome Measures

Name	Time	Method
Changes in the patient perioperative outcomes	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.
Changes to the responses on the validated patient surveys	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.

Trial Locations

Locations (2)

Youville Diabetes Center; 🇨🇦 Winnipeg, Manitoba, Canada

I.H. AsperInstitute, St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada