A New Glucose Meter With Alternative Site Testing
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
|Study Design:||Allocation: Non-Randomized
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 Alternative Site Testing [Commercial Name is CONTOUR® USB]|
- Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results [ Time Frame: One hour ] [ Designated as safety issue: No ]Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
- Percentage of Participants Rated as <=3 (Labeling Comprehension) [ Time Frame: One hour ] [ Designated as safety issue: No ]
Study staff rated participants as to their success at performing meter testing. 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.)
- Percentage of Participant 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 Monitor 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 with blood obtained from the palm and forearm
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
Other Name: Commercial name is CONTOUR® USB
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.
|United States, Michigan|
|Jasper Clinic, Inc.|
|Kalamazoo, Michigan, United States, 49007|
|Principal Investigator:||Vimala Sethy, MD, PhD||Jasper Clinic, Inc.|