DRIVE Diabetes Registry to Improve Vascular Events

1
DRIVE (Diabetes Registry to Improve Vascular
Events )

• Conceived, designed, and managed by the Canadian
  Heart Research Centre
• Federally-incorporated, not-for-profit, academic
  research organization
• Sponsored by Aventis Canada
• Ethically approved protocol
• Patients sign an informed consent form

2
Objectives

• 1. physician education
• 2. monitoring of patient outcomes
• 3. closing the care gap by providing the results
  of real life outcomes to managing physicians

3
Steering Committee

• Lawrence Leiter, MD (Chair)
• Keith Dawson, MD
• David Fitchett, MD
• Hertzel C. Gerstein, MD
• Shaun Goodman, MD
• Stewart Harris, MD
• George Honos, MD
• Anatoly Langer, MD
• Philip McFarlane, MD
• Andrew Steele, MD
• Ehud Ur, MD
• Jean-Francois Yale, MD

4
Physicians

• Target 300 Canadian MDs
• Family/General Practitioners
• Internal Medicine Specialists
• Endocrinologists
• Prior to patient enrolment
• Chart Review
• Investigators meeting
• Review evidence relevant to high vascular risk
  patient such as those with diabetes
• Protocol and CRF review

5
Patient Selection

• Type 2 diabetes mellitus (DM) based on any one of
  the following
• Treatment with an oral hypoglycemic agent or
  insulin
• Symptoms of diabetes (including fatigue,
  polyuria, polydipsia and unexplained weight loss)
  plus a random/casual plasma glucose value ?11.1
  mmol/L
• Fasting plasma glucose (FPG) ?7.0 mmol/L
• A 2 hour post 75 g glucose challenge plasma
  glucose ?11.1 mmol/L
• The diagnosis of type 2 (as opposed to type 1)
  diabetes will be made on clinical criteria that
  will include ALL of the following
• Diagnosis after the age of 30
• Lack of history of ketoacidosis
• Lack of requirement for insulin therapy within
  the first 6 months of diagnosis of diabetes

6
Patient Benefits

• Type 2 DM patients generally have a risk of
  cardiovascular disease development or endpoint
  (e.g., death, MI) of at least 20 over 10 years.
• It is thought that aggressive and comprehensive
  evidence based management of these patients may
  reduce their relative risk by up to 30-50.

7
Data Collection

• case report forms (CRFs) scanned into an
  electronic database (Teleform? system)
• queries regarding incomplete/unclear data
  returned to sites for correction/clarification
• 6 and 12 month follow-up by MD

8
Case Report Form (CRF)

• The data collected will include
• Baseline demographics including age, gender,
  height, weight, BMI, waist circumference
• Diabetes history including duration of DM, use of
  oral agents and/or insulin, and presence or
  absence of diabetic complications
• Use of vascular protective strategies including
  control of lipids, blood pressure, and glycemia
  as well as use of an ace inhibitor and ASA (all
  based on CDA Guidelines)