In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.
|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|
- 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.
- 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:
- 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 ] [ 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.
|Study Start Date:||December 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
|United States, California|
|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|
|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|