Diabetes, Hypertension
Conditions
Keywords
Diabetes
Brief summary
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.
Interventions
DEVICEBlood pressure monitor with telemetry
Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager
DEVICEHome blood pressure monitor without telemetry
Self monitor of blood pressure without telemetry
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 (inclusive * Blood pressure in hypertensive range (systolic \>= 140 or diastolic \>=90 * Diabetes
Exclusion criteria
* Pregnancy * Lack of computer with internet access or phone line * Lack of English language literacy * Arm size to large or small for cuff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Systolic Blood Pressure | 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 | Baseline, 6 months | Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and enrolled at the Mayo Clinic in Rochester, Minnesota from March 2011 to October 2012.
Participants by arm
| Arm | Count |
|---|---|
| Blood Pressure With Telemetry Blood pressure monitor with telemetry
blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager | 25 |
| Blood Pressure Without Telemetry Blood pressure self monitor without telemetry
Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
Baseline characteristics
| Characteristic | Blood Pressure With Telemetry | Blood Pressure Without Telemetry | Total |
|---|---|---|---|
| Age, Continuous | 63.24 years STANDARD_DEVIATION 7.93 | 62.36 years STANDARD_DEVIATION 8.55 | 62.8 years STANDARD_DEVIATION 8.17 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Mean Change in Diastolic Blood Pressure
Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Blood Pressure With Telemetry | Mean Change in Diastolic Blood Pressure | -1.92 Millimeters of Mercury |
| Blood Pressure Without Telemetry | Mean Change in Diastolic Blood Pressure | 1.72 Millimeters of Mercury |
Primary
Mean Change in Systolic Blood Pressure
Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Blood Pressure With Telemetry | Mean Change in Systolic Blood Pressure | -3.08 Millimeters of Mercury |
| Blood Pressure Without Telemetry | Mean Change in Systolic Blood Pressure | 2.72 Millimeters of Mercury |