NCT00325624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Nov 2006

Typical duration for phase_1 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

May 12, 2006

Last Update Submit

May 21, 2012

Conditions

HypertensionDiabetes Mellitus

Keywords

Blood PressureDiabetes mellitusHypertensionHome CareGlucometer

Outcome Measures

Primary Outcomes (1)

  • A1c

    Change of A1c over 1 year

    1 year

Interventions

Bluetooth-enabled GlucometerDEVICE

blood glucose information provided to health care providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Battleford Tribal Council Indian Health Services

North Battleford, Saskatchewan, S9A 0V0, Canada

Location

Related Publications (1)

  • Tobe SW, Wentworth J, Ironstand L, Hartman S, Hoppe J, Whiting J, Kennedy J, McAllister C, Kiss A, Perkins N, Vincent L, Pylypchuk G, Lewanczuk RZ. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol. BMC Endocr Disord. 2009 May 9;9:13. doi: 10.1186/1472-6823-9-13.

    PMID: 19426530DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sheldon W Tobe, MD, FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • George Pylypchuk, MD, FRCP(C)

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, University of Toronto

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

CA(2)