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NCT Number: NCT01824277

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in A1C over the study period.

    Time frame: Baseline to the patients' 3-months post-operative appointment

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dr. Rakesh C. Arora

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Apr 4, 2013
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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