User Study for Enhanced Meter Feature
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01889355|
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.
This study will evaluate a user's ability to use the enhanced meter feature.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: AgaMatrix Blood Glucose Monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
Enhanced meter feature usability
Home diabetes monitoring by patient using provided blood glucose monitoring system.
Device: AgaMatrix Blood Glucose Monitor
- Enhanced Meter Feature Usability [ Time Frame: 4 weeks ]The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
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): NCT01889355
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|