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.
Device: Bluetooth-enabled Glucometer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)|
- A1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]Change of A1c over 1 year
|Study Start Date:||November 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Device: Bluetooth-enabled Glucometer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325624
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Battleford Tribal Council Indian Health Services|
|North Battleford, Saskatchewan, Canada, S9A 0V0|
|Principal Investigator:||Sheldon W Tobe, MD, FRCPC||Sunnybrook Health Sciences Centre|
|Principal Investigator:||George Pylypchuk, MD, FRCP(C)||University of Saskatchewan|