Clinical trial NCT00456105: 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
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Peripheral Vascular Disease
Keywords: Type 2 diabetes
Post-op dysglycemia
Peripheral vascular disease
Infrainguinal bypass surgery
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2007-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Glycemic control
Secondary outcomes:
measure: Length of stay
measure: Infection
measure: Readmission
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Gerontology & Diabetes Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Graydon Meneilly, MD
role: PRINCIPAL_INVESTIGATOR
References: