Trial Outcomes & Findings for Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes (NCT NCT01300338)

NCT ID: NCT01300338

Last Updated: 2014-04-24

Results Overview

Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline, 6 months
• Results posted on: 2014-04-24

Participant Flow

Participants were recruited and enrolled at the Mayo Clinic in Rochester, Minnesota from March 2011 to October 2012.

Participant milestones

Measure	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	Blood Pressure Without Telemetry Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry.
Overall Study STARTED	25	25
Overall Study COMPLETED	20	25
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Measure	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	Blood Pressure Without Telemetry Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry.
Overall Study Lost to Follow-up	5	0

Baseline Characteristics

Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

Baseline characteristics by cohort

Measure	Blood Pressure With Telemetry n=25 Participants 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	Blood Pressure Without Telemetry n=25 Participants Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry	Total n=50 Participants Total of all reporting groups
Age, Continuous	63.24 years STANDARD_DEVIATION 7.93 • n=5 Participants	62.36 years STANDARD_DEVIATION 8.55 • n=7 Participants	62.8 years STANDARD_DEVIATION 8.17 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.

Outcome measures

Measure	Blood Pressure With Telemetry n=20 Participants 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	Blood Pressure Without Telemetry n=25 Participants Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry
Mean Change in Systolic Blood Pressure	-3.08 Millimeters of Mercury Interval -8.6 to 2.4	2.72 Millimeters of Mercury Interval -5.6 to 11.0

PRIMARY outcome

Timeframe: Baseline, 6 months

Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.

Outcome measures

Measure	Blood Pressure With Telemetry n=20 Participants 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	Blood Pressure Without Telemetry n=25 Participants Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry
Mean Change in Diastolic Blood Pressure	-1.92 Millimeters of Mercury Interval -5.2 to 1.4	1.72 Millimeters of Mercury Interval -2.3 to 5.7

Adverse Events

Blood Pressure With Telemetry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blood Pressure Without Telemetry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Frederick North

Mayo Clinic

Phone: 507-284-5164

Email: North.Frederick@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place