Glucose Meter Study

Study Overview
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Brief Summary
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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.

Official Title
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A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Education + new meter
* Device: Education + new meter + feature activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Level1 Basic Meter Features<br>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<br>* Diabetes education and a new meter with basic features<br>|
| Experimental: Level 2 Advanced Meter Features<br>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<br>* Diabetes education and a new meter with advanced features<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 | 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. | Over six month period |