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

University of British Columbia

Status: Terminated

Conditions: Peripheral Vascular Disease; Type 2 Diabetes

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00456105

H05-70482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 30+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups, including a placebo group

1

Active Comparator group

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.

Treatment:

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

2

Experimental group

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.

Treatment:

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 group

Description:

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

Treatment:

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