Study Results
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View full resultsBasic Information
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COMPLETED
NA
211 participants
INTERVENTIONAL
2008-11-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Education + new meter
Diabetes education and a new meter with basic features
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.
Education + new meter + feature activation
Diabetes education and a new meter with advanced features
Interventions
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Education + new meter
Diabetes education and a new meter with basic features
Education + new meter + feature activation
Diabetes education and a new meter with advanced features
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Dace Trence, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington Medical Center/Diabetes Care Center
Bruce W Bode, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Diabetes Associates
Ronald Tamler, MD, Phd, MBA
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Richard M Bergenstal, MD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Locations
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Atlanta Diabetes Associates
Atlanta, Georgia, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Washington Medical Center/Diabetes Care Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CTD-2008-09
Identifier Type: -
Identifier Source: org_study_id
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