Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
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|ClinicalTrials.gov Identifier: NCT00797563|
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : December 22, 2009
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: Apollo Blood Glucose Monitoring System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]|
|Study Start Date :||November 2008|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System 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
- Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method [ Time Frame: One hour ]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 ]
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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797563
|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.|