Glucose Meter Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00782496
First received: October 28, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.


Condition Intervention
Diabetes Mellitus
Device: Education + new meter
Device: Education + new meter + feature activation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 [ Time Frame: Over six month period ] [ Designated as safety issue: No ]
    Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.


Enrollment: 211
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Level1 Basic Meter Features
Adults with type 1 and type 2 diabetes use only basic features (Level 1) to test their blood. The CONTOUR meter has the basic features such as small meter size, easy to use , No Coding™ technology, 5-second test time, small sample size (0.6 µL), automatic control solution marking, 480 reading memory capacity.
Device: Education + new meter
Diabetes education and a new meter with basic features
Experimental: Level 2 Advanced Meter Features
Adults with type 1 and type 2 diabetes additionally access and use more advanced meter features(Level 2)during blood glucose testing. The advanced features include ability to mark blood glucose values as obtained before or after meals or to set an audible reminder to test.
Device: Education + new meter + feature activation
Diabetes education and a new meter with advanced features

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persons with type 1 or type 2 diabetes
  2. Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
  3. Persons at least 21 years of age
  4. Persons willing to complete all study visits and study procedures including:

    • Using the meal-marker + reminder feature regularly (Group 2 subjects only)
    • Using the paper logbook provided (both Groups)
  5. Testing their BG at least 3 times a day during the entire study.
  6. Persons who are able to speak, read and understand English
  7. Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more

Exclusion Criteria:

  1. Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
  2. Persons who test over 6 times/day regularly
  3. Persons who wear a BG sensor 2 weeks or more during each month.
  4. Persons with home heath aides who assist with their BG testing.
  5. Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:

    • Significant visual impairment
    • Significant hearing impairment
    • Cognitive disorder
    • Significant unstable co-morbidity (with notable change within the past 3 months)
  6. Any other condition as per investigator's discretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782496

Locations
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, New York
Mount Sinai School of Medicine
New York City, New York, United States, 10029
United States, Washington
University of Washington Medical Center/Diabetes Care Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Dace Trence, MD University of Washington Medical Center/Diabetes Care Center
Principal Investigator: Bruce W Bode, MD Atlanta Diabetes Associates
Principal Investigator: Ronald Tamler, MD, Phd, MBA Mount Sinai School of Medicine
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00782496     History of Changes
Other Study ID Numbers: CTD-2008-09
Study First Received: October 28, 2008
Results First Received: September 27, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014