Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Frederick North, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01300338

First received: February 17, 2011

Last updated: June 29, 2012

Last verified: June 2012

History of Changes

Purpose

Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

Condition	Intervention
Diabetes	Device: blood pressure with telemetry Device: Home blood pressure monitor without telemetry

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Blood pressure control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion subjects with blood pressure goal met

Secondary Outcome Measures:

Contacts with primary care provider [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of physician provider contacts

Enrollment:	50
Study Start Date:	March 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Blood pressure with telemetry Blood pressure monitor with telemetry	Device: blood pressure with telemetry Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager Other Name: Ideal Life Blood Pressure Monitor
Active Comparator: blood pressure without telemetry Blood pressure self monitor without telemetry	Device: Home blood pressure monitor without telemetry Self monitor of blood pressure without telemetry Other Name: Omron blood pressure monitor

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300338

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Frederick North, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Frederick North, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01300338 History of Changes
Other Study ID Numbers:	10-003562
Study First Received:	February 17, 2011
Last Updated:	June 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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