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

Diabetes Clinical Trial

Official title:

Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333853
• Other study ID #: DDI 70-97017-17
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: May 12, 2008
• Start date: August 2003
• Est. completion date: June 2005

Study information

• Verified date: May 2008
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• OneTouch(r) UltraSmart(r)

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Diabetes and Endocrine Associates	La Jolla	California
United States	Children's Hospital, Los Angeles	Los Angeles	California
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Radiant Research	Portland	Oregon
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)
Secondary	Measured hypoglycemia