Glucose Meter Study

Overview

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.

Full Title of Study: “A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2009

Interventions

  • Device: Education + new meter
    • Diabetes education and a new meter with basic features
  • Device: Education + new meter + feature activation
    • Diabetes education and a new meter with advanced features

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ascensia Diabetes Care
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dace Trence, MD, Principal Investigator, University of Washington Medical Center/Diabetes Care Center
    • Bruce W Bode, MD, Principal Investigator, Atlanta Diabetes Associates
    • Ronald Tamler, MD, Phd, MBA, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Richard M Bergenstal, MD, Principal Investigator, International Diabetes Center at Park Nicollet

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.