User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS

AgaMatrix, Inc.1 site in 1 country121 target enrollmentJanuary 2014

ConditionsDiabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: AgaMatrix, Inc.
Enrollment: 121
Locations: 1
Primary Endpoint: Enhanced Meter Feature Usability
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

March 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AgaMatrix, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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).