Glucose Meter Study

Not Applicable

Completed

Interventions: Device: Education + new meter
Device: Education + new meter + feature activation

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Level1 Basic Meter Features	Education + new meter	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.
Level 2 Advanced Meter Features	Education + new meter + feature activation	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.

Primary Outcome Measures

Name	Time	Method
Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features	6 months

Secondary Outcome Measures

Name	Time	Method
Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2	Over six month period	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.

Locations (4): International Diabetes Center
🇺🇸
Minneapolis, Minnesota, United States
Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
University of Washington Medical Center/Diabetes Care Center
🇺🇸
Seattle, Washington, United States
Mount Sinai School of Medicine
🇺🇸
New York City, New York, United States