Status:

COMPLETED

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

Lead Sponsor:

LifeScan

Conditions:

Diabetes

Eligibility:

All Genders

Phase:

NA

Brief Summary

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) Ul...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    June 1 2005

    Estimated Enrollment :

    250 Patients enrolled

    Trial Details

    Trial ID

    NCT00333853

    Start Date

    August 1 2003

    End Date

    June 1 2005

    Last Update

    May 13 2008

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    Diabetes and Endocrine Associates

    La Jolla, California, United States, 92037

    2

    Children's Hospital, Los Angeles

    Los Angeles, California, United States, 90027

    3

    University of Miami Miller School of Medicine

    Miami, Florida, United States, 33136

    4

    University of Maryland School of Medicine

    Baltimore, Maryland, United States, 21201