Glucose Meter Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00782496
• Lead Sponsor: Ascensia Diabetes Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-27
• Results First Submitted QC: 2010-11-01
• Results First Posted: 2010-11-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

1. Persons with type 1 or type 2 diabetes

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

1. Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (4)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States

Mount Sinai School of Medicine; 🇺🇸 New York City, New York, United States

University of Washington Medical Center/Diabetes Care Center; 🇺🇸 Seattle, Washington, United States