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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824277
• Other study ID #: GRT2012-53
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: St. Boniface General Hospital Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	I.H. AsperInstitute, St. Boniface General Hospital	Winnipeg	Manitoba
Canada	Youville Diabetes Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Rakesh C. Arora

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1C over the study period.		Baseline to the patients' 3-months post-operative appointment
Secondary	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
Secondary	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