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

NCT01824277 | Completed

• 1 other identifier: GRT2012-53
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in A1C over the study period.

  Baseline to the patients' 3-months post-operative appointment

Secondary Outcomes (2)

• Changes to the responses on the validated patient surveys

  Baseline to the patients' 3-months post-operative appointment

• Changes in the patient perioperative outcomes

  Baseline to the patients' 3-months post-operative appointment

Study Arms (2)

Group 1

NO INTERVENTION

Group 1 - Standard Pre-operative Diabetes Care

Group 2

EXPERIMENTAL

Group 2 - Structured Pre-operative Diabetes Optimization

Other: Structured Pre-operative Diabetes Optimization

Interventions

Structured Pre-operative Diabetes Optimization 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.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Progressive cognitive deficit or disease.
• Age \< 18
• Unable to provide informed consent
• A1C\<7%
• Undergoing emergent cardiac surgery

Sponsors & Collaborators

• Dr. Rakesh C. Arora: lead

Study Sites (2)

Youville Diabetes Center

Winnipeg, Manitoba, R2H 0S8, Canada

Location

I.H. AsperInstitute, St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rakesh C Arora, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Sora Ludwig, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Intensive Care Cardiac Sciences

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: April 4, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

CA (2)