NCT01300338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 24, 2014

Completed
Last Updated

April 24, 2014

Status Verified

March 1, 2014

Enrollment Period

1.6 years

First QC Date

February 17, 2011

Results QC Date

March 24, 2014

Last Update Submit

March 24, 2014

Conditions

Keywords

Diabetes

Outcome Measures

Primary Outcomes (2)

  • Mean Change in Systolic Blood Pressure

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

    Baseline, 6 months

  • Mean Change in Diastolic Blood Pressure

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

    Baseline, 6 months

Study Arms (2)

Blood pressure with telemetry

EXPERIMENTAL

Home blood pressure monitor with telemetry

Device: Blood pressure monitor with telemetry

Blood pressure without telemetry

ACTIVE COMPARATOR

Home blood pressure self monitor without telemetry.

Device: Home blood pressure monitor without telemetry

Interventions

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

Also known as: Ideal Life Blood Pressure Monitor
Blood pressure with telemetry

Self monitor of blood pressure without telemetry

Also known as: Omron blood pressure monitor
Blood pressure without telemetry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 (inclusive
  • Blood pressure in hypertensive range (systolic \>= 140 or diastolic \>=90
  • Diabetes

You may not qualify if:

  • Pregnancy
  • Lack of computer with internet access or phone line
  • Lack of English language literacy
  • Arm size to large or small for cuff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypertension

Interventions

Blood Pressure MonitorsTelemetry

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and SuppliesMonitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Dr. Frederick North
Organization
Mayo Clinic

Study Officials

  • Frederick North, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 21, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 24, 2014

Results First Posted

April 24, 2014

Record last verified: 2014-03

Locations