Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)
Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)
The purpose behind the proposed research is that diabetes care in First Nations people can be
 improved by involvement of a Home Care team providing diabetes education and management,
 supported by emerging technology, specifically Bluetooth-enabled glucometers and blood
 pressure monitors, capable of transmitting their data to a web environment in tabulated and
 graphical format available for remote viewing.
Diabetes mellitus is a systemic disease that produces a diverse array of complications. The
 pathogenesis of these complications refers back to two factors, one of which (high blood
 glucose) alters proteins leading to tissue and blood vessel damage, while the other (high
 blood pressure), exacerbates the vascular damage causing further damage to target organs. Our
 long term goal is to achieve targets for blood glucose and blood pressure as outlined by
 Clinical Practice Guidelines.

 Despite current Clinical Practice Guidelines and evidence-based practice by the medical
 community, including family physicians and the Home Care team, blood glucose control in
 general and in the First Nations community specifically is not meeting targets. Poor control
 of blood glucose in type 2 diabetes dramatically increases the risk of heart disease, stroke,
 vascular limb loss, blindness, kidney disease and the need for dialysis. Control of blood
 glucose levels prevents these complications. Additionally, the intensification of diabetes
 control, including the initiation of insulin, is not easily done during a regular primary
 care visit. The lack of intensification of diabetes management in people with poorly
 controlled diabetes has been referred to as 'clinical inertia'. While subjects referred to
 specialists have somewhat better control of diabetes, more than 50% still failed to have
 intensification of diabetes management within four months of a lab report showing a high
 level of A1c. Multidisciplinary care can overcome clinical inertia, even in difficult
 practice settings. Finally, the emerging technology of Bluetooth-enabled devices and secure
 web-based monitoring logs allows health care providers for the first time to remotely monitor
 progress providing a higher level of confidence in self blood glucose monitoring (SBGM) and
 blood pressure results. Based on these facts, the experimental focus of this proposal is on
 the introduction of a Home Care Team diabetes management program that can provide
 intensification of diabetes management right in the patient's home, supported by the emerging
 technology of Bluetooth- enabled devices. The specific aims are designed to provide a
 comprehensive assessment of the impact of the introduction of this program.
Inclusion Criteria:

 -  Type 2 Diabetes with baseline A1c > 8.0 % on diet or medical therapy with no history
 of diabetic ketoacidosis.

 -  Patients must be greater than or equal to 18 years of age.

 -  Written informed consent must be obtained prior to admission to this study.

 Exclusion Criteria:

 -  Hypoglycemic therapy and A1c<8.0%

 -  New York Heart Association Stage III-IV congestive heart failure. This will eliminate
 approximately 2% of people with diabetes based on the Strong Heart Study Data.

 -  Suspected secondary hypertension due to any cause (e.g. pheochromocytoma,coarction of
 the aorta or renal insufficiency.)

 -  Unstable angina, myocardial infarction, or revascularization within the last 3 months.

 -  Angioedema.

 -  Cerebrovascular event, including stroke or transient ischemic attack, within the last
 six months.

 -  Creatinine >250 umol/L

 -  Cerebral Vascular event, including strike or transient ischemic attack, within the
 last six months.

 -  Connective tissue disorders (e.g.lupus, rheumatoid arthritis)

 -  Active hepatic disease as indicated by AST and ALT >2X the upper limit of normal;
 serum bilirubin >1.5X upper limit of normal, or serum albumin <3.0 gm/dl.

 -  Severe systemic or malignant disease(which could reasonably be expected to be fatal or
 life-threatening during the course of the study.)

 -  Pregnancy. It is expected that some women will want to exit the study to become
 pregnant (5% of female enrollees).

 -  Factors suggesting low likelihood of compliance with the protocol (e.g current alcohol
 abuse, history of unreliability in keeping appointments or taking medications.

 -  Any medical condition that study physicians believe would interfere with study
 participation or evaluation of results.

 -  Mental incapacity and/or cognitive impairment on the part of the patient that would
 preclude adequate understanding of, or cooperation with, the study protocol.

 -  Participation in any clinical trial of any investigational medication within 3 months
 prior to this trial. This is unlikely because clinical trials among First Nations
 people are rare.