DiabetesNCT01300338
Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes
A study testing Blood pressure monitor with telemetry and Home blood pressure monitor without telemetry in people with Diabetes and Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Blood pressure monitor with telemetry and Home blood pressure monitor without telemetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 (inclusive
- Blood pressure in hypertensive range (systolic >= 140 or diastolic >=90
- Diabetes
Who cannot join
- Pregnancy
- Lack of computer with internet access or phone line
- Lack of English language literacy
- Arm size to large or small for cuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?
Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?
Read the detailed description
This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.
- Conditions
- Diabetes, Hypertension
- Being tested
- Blood pressure monitor with telemetry, Home blood pressure monitor without telemetry
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure monitor with telemetryDevice
Also called Ideal Life Blood Pressure Monitor
Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager
Home blood pressure monitor without telemetryDevice
Also called Omron blood pressure monitor
Self monitor of blood pressure without telemetry
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure with telemetry | Experimental | Home blood pressure monitor with telemetry Receives: Device: Blood pressure monitor with telemetry |
| Blood pressure without telemetry | Active comparator | Home blood pressure self monitor without telemetry. Receives: Device: Home blood pressure monitor without telemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Systolic Blood Pressure
Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.
Measured: Baseline, 6 months
Mean Change in Diastolic Blood Pressure
Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick North, Mayo Clinic
- Investigators
- Frederick North, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300338
- Sponsor's protocol ID
- 10-003562
- Status last verified
- Mar 2014
- First submitted
- 17 Feb 2011
- Last updated
- 24 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?
- ClinicalTrials.gov ID
- NCT01300338
- Acronym / sponsor ID
- 10-003562
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Posted 24 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?
Detailed description
This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood pressure with telemetry | Experimental | Device: Blood pressure monitor with telemetryHome blood pressure monitor with telemetry |
| Blood pressure without telemetry | Active comparator | Device: Home blood pressure monitor without telemetryHome blood pressure self monitor without telemetry. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 (inclusive
- Blood pressure in hypertensive range (systolic >= 140 or diastolic >=90
- Diabetes
Key exclusion criteria (4 listed)
- Pregnancy
- Lack of computer with internet access or phone line
- Lack of English language literacy
- Arm size to large or small for cuff
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 |
|---|---|---|
| Blood pressure monitor with telemetryAlso: Ideal Life Blood Pressure MonitorBlood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager | Device | Blood pressure with telemetry |
| Home blood pressure monitor without telemetryAlso: Omron blood pressure monitorSelf monitor of blood pressure without telemetry | Device | Blood pressure without telemetry |
Primary outcome
Mean Change in Systolic Blood Pressure
Time frame: Baseline, 6 months
Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.
Mean Change in Diastolic Blood Pressure
Time frame: Baseline, 6 months
Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frederick North, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure monitor with telemetry and Home blood pressure monitor without telemetry in people with Diabetes and Hypertension, run by Mayo Clinic at 1 site in United States.
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 4 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 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Systolic Blood Pressure (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2014.