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Completed

NCT Number: NCT01300338

Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

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

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood pressure monitor with telemetry

Device

Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager

Other names: Ideal Life Blood Pressure Monitor

Home blood pressure monitor without telemetry

Device

Self monitor of blood pressure without telemetry

Other names: Omron blood pressure monitor

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2011
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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