Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm)
1 other identifier
interventional
250
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Aug 2003
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
June 6, 2006
CompletedMay 13, 2008
May 1, 2008
June 2, 2006
May 12, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c)
Secondary Outcomes (1)
Measured hypoglycemia
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeScanlead
Study Sites (7)
Diabetes and Endocrine Associates
La Jolla, California, 92037, United States
Children's Hospital, Los Angeles
Los Angeles, California, 90027, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Radiant Research
Portland, Oregon, 97239, United States
Related Publications (1)
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.
PMID: 17561796RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Laffel, MD, MPH
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2006
First Posted
June 6, 2006
Study Start
August 1, 2003
Study Completion
June 1, 2005
Last Updated
May 13, 2008
Record last verified: 2008-05