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

Primary Purpose

Type 2 Diabetes, Peripheral Vascular Disease

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team
Subjects without diabetes will have their blood glucose levels monitored while in the hospital
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Post-op dysglycemia, Peripheral vascular disease, Infrainguinal bypass surgery

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia Gerontology & Diabetes Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

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.

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.

Subjects without diabetes will have their blood glucose levels monitored while in the hospital.

Outcomes

Primary Outcome Measures

Glycemic control

Secondary Outcome Measures

Length of stay
Infection
Readmission

Full Information

First Posted
April 2, 2007
Last Updated
January 16, 2018
Sponsor
University of British Columbia
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00456105
Brief Title
The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to lack of resources of the study coordinator's time
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Peripheral Vascular Disease
Keywords
Type 2 diabetes, Post-op dysglycemia, Peripheral vascular disease, Infrainguinal bypass surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Subjects without diabetes will have their blood glucose levels monitored while in the hospital.
Intervention Type
Behavioral
Intervention Name(s)
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician
Intervention Description
See Detailed Description.
Intervention Type
Behavioral
Intervention Name(s)
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team
Intervention Description
See detailed description.
Intervention Type
Behavioral
Intervention Name(s)
Subjects without diabetes will have their blood glucose levels monitored while in the hospital
Intervention Description
See detailed description.
Primary Outcome Measure Information:
Title
Glycemic control
Secondary Outcome Measure Information:
Title
Length of stay
Title
Infection
Title
Readmission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graydon Meneilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia Gerontology & Diabetes Research Centre
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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

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