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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:
ClinicalTrials.gov Identifier:
NCT00333853
First Posted: June 6, 2006
Last Update Posted: May 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
LifeScan
  Purpose
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).

Condition Intervention
Diabetes Device: OneTouch(r) UltraSmart(r)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by LifeScan:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c)

Secondary Outcome Measures:
  • Measured hypoglycemia

Estimated Enrollment: 250
Study Start Date: August 2003
Estimated Study Completion Date: June 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333853


Locations
United States, California
Diabetes and Endocrine Associates
La Jolla, California, United States, 92037
Children's Hospital, Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97239
Sponsors and Collaborators
LifeScan
Investigators
Principal Investigator: Lori Laffel, MD, MPH Joslin Diabetes Center
  More Information

Publications:
Responsible Party: LifeScan, Inc.
ClinicalTrials.gov Identifier: NCT00333853     History of Changes
Other Study ID Numbers: DDI 70-97017-17
First Submitted: June 2, 2006
First Posted: June 6, 2006
Last Update Posted: May 13, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases