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

NCT ID: NCT01824277

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-07-31

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).

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1 - Standard Pre-operative Diabetes Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Group 2 - Structured Pre-operative Diabetes Optimization

Group Type EXPERIMENTAL

Structured Pre-operative Diabetes Optimization

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Rakesh C. Arora

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rakesh C. Arora

Medical Director, Intensive Care Cardiac Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rakesh C Arora, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Sora Ludwig, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Youville Diabetes Center

Winnipeg, Manitoba, Canada

Site Status

I.H. AsperInstitute, St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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GRT2012-53

Identifier Type: -

Identifier Source: org_study_id

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