Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]|
- Percentage of Participants Rated as <=3 (Comprehension of Labeling) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:
- Successful in performing tasks correctly without assistance
- Successful after being referred to user instructions
- Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
- Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
- Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.
|Study Start Date:||December 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood.
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.
Other Name: Commercial name is CONTOUR® USB
The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.
|United States, Minnesota|
|International Diabetes Center|
|Minneapolis, Minnesota, United States, 55416|
|Principal Investigator:||Robert Cuddihy, MD||International Diabetes Center at Park Nicollet|