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

Overview

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

Full Title of Study: “In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2009

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
    • Time Frame: 1-2 hours
    • 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
    • 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 Measures

  • Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
    • Time Frame: 1-2 hours
    • 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
    • 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: Successful in performing tasks correctly without assistance Successful after study staff prompted participant to review User Guide. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.) 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ascensia Diabetes Care
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Javier Aisenberg, MD, Principal Investigator, Hackensack Meridian Health
    • Georgeanna Klingensmith, MD, Principal Investigator, Barbara Davis Center
    • Francine Kaufman, MD, Principal Investigator, Children’s Hospital Los Angeles
    • Timothy Bailey, MD, Principal Investigator, AMCR Institute

Citations Reporting on Results

Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8.

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