Status:
COMPLETED
Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Battlefords Tribal Council Indian Health Services
SaskTel
Conditions:
Hypertension
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 emer...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00325624
Start Date
November 1 2006
End Date
April 1 2008
Last Update
May 23 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
2
Battleford Tribal Council Indian Health Services
North Battleford, Saskatchewan, Canada, S9A 0V0