HypertensionPhase 1DREAM-TelNCT00325624
Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)
A Phase 1 study testing Bluetooth-enabled Glucometer in people with Hypertension and Diabetes Mellitus, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- Bluetooth-enabled Glucometer
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2006to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Battleford Tribal Council Indian Health Services
North Battleford, Saskatchewan, S9A 0V0
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
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.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- Bluetooth-enabled Glucometer
- Keywords
- Blood Pressure, Diabetes mellitus, Hypertension, Home Care, Glucometer
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluetooth-enabled GlucometerDevice
blood glucose information provided to health care providers
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Change of A1c over 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Battlefords Tribal Council Indian Health Services, SaskTel
- Responsible party
- Principal investigator, Sheldon Tobe, Sunnybrook Health Sciences Centre
- Investigators
- Sheldon W Tobe, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences CentreGeorge Pylypchuk, MD, FRCP(C), Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325624
- Sponsor's protocol ID
- 2006-04
- Acronym
- DREAM-Tel
- Status last verified
- May 2012
- First submitted
- 12 May 2006
- Last updated
- 23 May 2012
- Results posted
- No
Publications
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.
PubMed 19426530
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Risk Evaluation and Management Tele-monitoring Study (DREAM-Tel)
- ClinicalTrials.gov ID
- NCT00325624
- Acronym / sponsor ID
- DREAM-Tel / 2006-04
- Conditions
- Hypertension, Diabetes Mellitus
- Keywords
- Blood Pressure, Diabetes mellitus, Hypertension, Home Care, Glucometer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Battlefords Tribal Council Indian Health Services, SaskTel
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bluetooth-enabled Glucometerblood glucose information provided to health care providers | Device | – |
Primary outcome
A1c
Time frame: 1 year
Change of A1c over 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Derived from this study: PubMed 19426530Tobe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon W Tobe, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
George Pylypchuk, MD, FRCP(C) principal investigator
University of Saskatchewan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bluetooth-enabled Glucometer in people with Hypertension and Diabetes Mellitus, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1c (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012; AzTrials last refreshed its copy on 8 Nov 2026.