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

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT00333853
• Lead Sponsor: LifeScan

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) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study Completion: 2005-06
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-12
• Last Update Posted: 2008-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Name	Time	Method
Measured hypoglycemia

Trial Locations

Locations (7)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Diabetes and Endocrine Associates; 🇺🇸 La Jolla, California, United States

Children's Hospital, Los Angeles; 🇺🇸 Los Angeles, California, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Radiant Research; 🇺🇸 Portland, Oregon, United States