In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
|ClinicalTrials.gov Identifier: NCT00803777|
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : June 16, 2010
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Investigational Blood Glucose Monitoring System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803777
|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|