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

Study Overview
=================
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.

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

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* See Detailed Description.<br>|
| Experimental: 2<br>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<br>* See detailed description.<br>|
| Placebo Comparator: 3<br>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<br>* See detailed description.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  |  | 
| Infection |  |  | 
| Readmission |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Post-op dysglycemia, Peripheral vascular disease, Infrainguinal bypass surgery