The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes

Early Post-Operative Dysglycemia in Patients With and Without Diabetes Post-Infrainguinal Bypass Surgery and the Effectiveness of a Diabetes Action Team in the Management of Diabetes Post Infrainguinal Bypass Surgery on Glycemic Control, Length of Stay, and Infection Rates: A Pilot Study

Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high.

The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes; Peripheral Vascular Disease
• Intervention / Treatment: Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician; Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team; Behavioral: Subjects without diabetes will have their blood glucose levels monitored while in the hospital

Detailed Description

This trial will randomize subjects with diabetes who plan to undergo elective infrainguinal bypass surgery to receive either standard diabetes care by their admitting physician, or diabetes care under the direction of the Diabetes Action Team post operatively until hospital discharge and post discharge in the community. Subjects without diabetes will have their blood glucose levels monitored while in the hospital. The Diabetes Action team will consist of a nurse coordinator who is a Certified Diabetes Educator (CDE) and a team of physicians specialized in the management of diabetes. The study will not increase the length of the hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia Gerontology & Diabetes Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Non-Diabetes:

• Fasting blood glucose < 7.0 mmol/L or a random blood glucose of < 11.1 mmol/L

Diabetes:

• Poorly controlled type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 or random plasma glucose greater than or equal to 10.0 mmol/L)
• Newly diagnosed type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 mmol/L or random plasma glucose greater than or equal to 11.1 mmol/L)
• Age > 30
• English-speaking
• Agrees to participate in the study and lives in the Lower Mainland

Exclusion Criteria:

• Scheduled to undergo surgery other than infrainguinal bypass surgery
• Under 30 years of age
• Living outside of Lower Mainland
• Cannot speak and understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician, post operatively until hospital discharge and post discharge in the community.	Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician; See Detailed Description.
Experimental: 2; Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team post operatively until hospital discharge and post discharge in the community. The Diabetes Action team will consist of a nurse coordinator who is a Certified Diabetes Educator (CDE) and a team of physicians specialized in the management of diabetes.	Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team; See detailed description.
Placebo Comparator: 3; Subjects without diabetes will have their blood glucose levels monitored while in the hospital.	Behavioral: Subjects without diabetes will have their blood glucose levels monitored while in the hospital; See detailed description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glycemic control

Secondary Outcome Measures

Outcome Measure
Length of stay
Infection
Readmission

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Graydon Meneilly, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 2, 2007
• First Submitted That Met QC Criteria: April 3, 2007
• First Posted (Estimate): April 4, 2007

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Peripheral vascular disease; Post-op dysglycemia; Infrainguinal bypass surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: H05-70482