NCT00456105

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

5.7 years

First QC Date

April 2, 2007

Last Update Submit

January 16, 2018

Conditions

Type 2 DiabetesPeripheral Vascular Disease

Keywords

Type 2 diabetesPost-op dysglycemiaPeripheral vascular diseaseInfrainguinal bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

Secondary Outcomes (3)

  • Length of stay

  • Infection

  • Readmission

Study Arms (3)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

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

3

PLACEBO COMPARATOR

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

Interventions

Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physicianBEHAVIORAL

See Detailed Description.

1
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action TeamBEHAVIORAL

See detailed description.

2
Subjects without diabetes will have their blood glucose levels monitored while in the hospitalBEHAVIORAL

See detailed description.

3

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Gerontology & Diabetes Research Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Graydon Meneilly, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

July 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

CA(1)