Glucose Meter Study - Full Text View

Sponsored by:	Bayer HealthCare, Diabetes Care
Information provided by:	Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:	NCT00782496

Purpose

The purpose of this study is to evaluate if maintained or increased frequency of testing blood sugar after meals and education enables behavioral changes that may lead to improvement in glycemic control, including A1C.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

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

Primary Outcome Measures:

Frequency of post-prandial testing [ Time Frame: 4 visits in 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall satisfaction of subjects and Health Care Professional, with the CONTOUR meal marker feature and reminder. [ Time Frame: Over six month period ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
L1: Experimental	Device: Education + new meter Diabetes education and a new meter
L2: Experimental	Device: Education + new meter + feature activation Subjects in L2 will receive additional education about the importance of the timing of their blood glucose testing and be introduced to a feature on the meter.

Eligibility

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

Criteria

Inclusion Criteria:

Persons with type 1 or type 2 diabetes
Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
Persons at least 21 years of age
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)
Testing their BG at least 3 times a day during the entire study.
Persons who are able to speak, read and understand English
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:

Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
Persons who test over 6 times/day regularly
Persons who wear a BG sensor 2 weeks or more during each month.
Persons with home heath aides who assist with their BG testing.
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)
Any other condition as per investigator's discretion

Contacts and Locations

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

More Information

Responsible Party:	Bayer Diabetes Care ( Holly Schachner, MD - Director, Medical Affairs )
Study ID Numbers:	CTD-2008-09
Study First Received:	October 28, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00782496
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009