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Clinical Trials/NCT00325624
NCT00325624
Completed
Phase 1

Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)

Sunnybrook Health Sciences Centre2 sites in 1 country40 target enrollmentNovember 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypertension
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
40
Locations
2
Primary Endpoint
A1c
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
April 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheldon Tobe

Associate Professor of Medicine, University of Toronto

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Outcomes

Primary Outcomes

A1c

Time Frame: 1 year

Change of A1c over 1 year

Study Sites (2)

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