Glucose Meter Study

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Education + new meter; Device: Education + new meter + feature activation

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta Diabetes Associates
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
  • New York
    • New York City, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington Medical Center/Diabetes Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Education + new meter; Diabetes education and a new meter with basic features
Experimental: 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.	Device: Education + new meter + feature activation; Diabetes education and a new meter with advanced features

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Richard M Bergenstal, MD, International Diabetes Center At Park Nicollet; 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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 31, 2008

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CTD-2008-09