Glucose Meter Study
A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients
1 other identifier
interventional
211
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Nov 2008
Shorter than P25 for not_applicable diabetes-mellitus
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
November 30, 2010
CompletedFebruary 29, 2016
January 1, 2016
10 months
October 28, 2008
September 27, 2010
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
6 months
Secondary Outcomes (1)
Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
Over six month period
Study Arms (2)
Level1 Basic Meter Features
EXPERIMENTALAdults 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.
Level 2 Advanced Meter Features
EXPERIMENTALAdults 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.
Interventions
Diabetes education and a new meter with basic features
Diabetes education and a new meter with advanced features
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Washington Medical Center/Diabetes Care Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carmine Greene, Senior Clinical Research Scientist
- Organization
- Ascensia Diabetes Care
Study Officials
- 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
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Richard M Bergenstal, MD
International Diabetes Center at Park Nicollet
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 31, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 29, 2016
Results First Posted
November 30, 2010
Record last verified: 2016-01