Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm)

NCT ID: NCT00333853

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-06-30

Brief Summary

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Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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OneTouch(r) UltraSmart(r)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%.
* The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs).
* The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment).
* Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeScan

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lori Laffel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

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Diabetes and Endocrine Associates

La Jolla, California, United States

Site Status

Children's Hospital, Los Angeles

Los Angeles, California, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Radiant Research

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Laffel LM, Hsu WC, McGill JB, Meneghini L, Volkening LK. Continued use of an integrated meter with electronic logbook maintains improvements in glycemic control beyond a randomized, controlled trial. Diabetes Technol Ther. 2007 Jun;9(3):254-64. doi: 10.1089/dia.2006.0021.

Reference Type RESULT
PMID: 17561796 (View on PubMed)

Other Identifiers

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DDI 70-97017-17

Identifier Type: -

Identifier Source: org_study_id