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

August 15, 2018 updated by: Dr. Rakesh C. Arora

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

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sora Ludwig, MD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

March 31, 2013

First Submitted That Met QC Criteria

March 31, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

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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