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

This study has been completed.
Sponsor:
Collaborators:
Battlefords Tribal Council Indian Health Services
SaskTel
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00325624
First received: May 12, 2006
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes Mellitus
Device: Bluetooth-enabled Glucometer
Phase 1

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • A1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change of A1c over 1 year


Enrollment: 40
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bluetooth-enabled Glucometer
    blood glucose information provided to health care providers
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325624

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Saskatchewan
Battleford Tribal Council Indian Health Services
North Battleford, Saskatchewan, Canada, S9A 0V0
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Battlefords Tribal Council Indian Health Services
SaskTel
Investigators
Principal Investigator: Sheldon W Tobe, MD, FRCPC Sunnybrook Health Sciences Centre
Principal Investigator: George Pylypchuk, MD, FRCP(C) University of Saskatchewan
  More Information

No publications provided

Responsible Party: Sheldon Tobe, Associate Professor of Medicine, University of Toronto, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00325624     History of Changes
Other Study ID Numbers: 2006-04
Study First Received: May 12, 2006
Last Updated: May 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Blood Pressure
Diabetes mellitus
Hypertension
Home Care
Glucometer

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014