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In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00803777
First received: December 5, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.


Condition Intervention
Diabetes
 Device: Investigational Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.

  • Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.


Secondary Outcome Measures:
  • Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies [ Time Frame: 1-2 hours ] [ Designated as safety issue: Yes ]
    The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences

  • Number of Participants Rated as <=2 (Labeling Comprehension) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:

    1. Successful in performing tasks correctly without assistance
    2. Successful after study staff prompted participant to review User Guide.
    3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)
    4. Subject did not perform task correctly and study staff intervention was required.

  • Average Within Replicate Coefficient of Variation CV (Precision) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.


Enrollment: 147
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intended Users of the Monitoring System
Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
 Device: Investigational Blood Glucose Monitoring System
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.

  Eligibility

Ages Eligible for Study:   4 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Age 4 to 24 years
  • Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
  • Has used a handheld game system to play video games within a year of enrollment
  • If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
  • Is willing to complete all study procedures, with appropriate parent/guardian supervision

Exclusion Criteria:

  • Hemophilia or any other bleeding disorder
  • Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
  • Infection with a blood borne pathogen (e.g., HIV, hepatitis)
  • Subject or parent/guardian is employee of competitive medical device company
  • Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803777

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Javier Aisenberg, MD Hackensack University Medical Center
Principal Investigator: Georgeanna Klingensmith, MD Barbara Davis Center
Principal Investigator: Francine Kaufman, MD Children's Hospital Los Angeles
Principal Investigator: Timothy Bailey, MD AMCR Institute
  More Information

Publications:

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00803777     History of Changes
Other Study ID Numbers: CTD-2008-23
Study First Received: December 5, 2008
Results First Received: March 8, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013