Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

NCT ID: NCT00401622

Last Updated: 2019-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-01

Study Completion Date

2009-01-01

Brief Summary

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Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OneTouch® Ultra®2 system

Test care group assigned to OneTouch® Ultra®2 system

Group Type EXPERIMENTAL

OneTouch® Ultra®2 System

Intervention Type BEHAVIORAL

Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program

Standard care

Control group receiving standard care with a traditional blood glucose monitoring system

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

Standard education and self-monitoring of blood glucose performed with traditional meter systems

Interventions

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OneTouch® Ultra®2 System

Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program

Intervention Type BEHAVIORAL

Standard care

Standard education and self-monitoring of blood glucose performed with traditional meter systems

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Current diagnosis of type 2 diabetes
* Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
* Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
* Baseline HbA1c of 7.0 to 8.9%, inclusive

Exclusion Criteria

* Using insulin
* Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
* Known history of anemia or disorders associated with anemia
* Has previously used the devices being tested in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synexus(UK)

UNKNOWN

Sponsor Role collaborator

CPS(UK)

UNKNOWN

Sponsor Role collaborator

Battelle CRO(US)

UNKNOWN

Sponsor Role collaborator

RPS CRO(US)

UNKNOWN

Sponsor Role collaborator

Robertson Centre For Biostatistics (UK)

UNKNOWN

Sponsor Role collaborator

LifeScan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

San Diego, California, United States

Site Status

Wilmington, Delaware, United States

Site Status

Hollywood, Florida, United States

Site Status

Dawsonville, Georgia, United States

Site Status

Whitehouse Station, New Jersey, United States

Site Status

East Syracuse, New York, United States

Site Status

Endwell, New York, United States

Site Status

Syracuse, New York, United States

Site Status

San Antonio, Texas, United States

Site Status

Oshawa, Ontario, Canada

Site Status

Windsor, Ontario, Canada

Site Status

Reading, Berkshire, United Kingdom

Site Status

Llanishen, Cardiff, United Kingdom

Site Status

Buckshaw Village, Chorley, United Kingdom

Site Status

Lloyd Street North, Manchester, United Kingdom

Site Status

Glasgow, Scotland, United Kingdom

Site Status

Claygate, Surrey, United Kingdom

Site Status

Countries

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United States Canada United Kingdom

Other Identifiers

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CR-1039797

Identifier Type: -

Identifier Source: org_study_id

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