Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederick North, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01300338
First received: February 17, 2011
Last updated: May 20, 2013
Last verified: May 2013
  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:


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
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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: May 20, 2013
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 April 22, 2014