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

This study has been completed.

Sponsor:

Information provided by:

LifeScan

ClinicalTrials.gov Identifier:

NCT00333853

First received: June 2, 2006

Last updated: May 12, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 2, 2006

Last Updated Date

May 12, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Hemoglobin A1c (HbA1c)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measured hypoglycemia

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Device: OneTouch(r) UltraSmart(r)

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00333853

Other Study ID Numbers ^ICMJE

DDI 70-97017-17

Has Data Monitoring Committee

Responsible Party

LifeScan, Inc.

Study Sponsor ^ICMJE

LifeScan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lori Laffel, MD, MPH

Joslin Diabetes Center

Information Provided By

LifeScan

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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