Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]|
- Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: One hour ] [ Designated as safety issue: No ]Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.
- Percentage of Participants Rated as <=3 (Labeling Comprehension) [ Time Frame: One hour ] [ Designated as safety issue: No ]
Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:
- Successful after being referred to user instructions
- Successful with 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 Partipants Who Gave These Ratings for Overall Testing Experience With This Meter [ Time Frame: One hour ] [ Designated as safety issue: No ]Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).
|Study Start Date:||November 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
Other Name: CONTOUR® USB
The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.
|United States, New Jersey|
|Consumer Product Testing Co., Inc.|
|Fairfield, New Jersey, United States, 07004|
|Principal Investigator:||Joy Frank, RN||Consumer Product Testing Co., Inc.|