User Study for Enhanced Meter Feature

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: AgaMatrix Blood Glucose Monitor

• Registration Number: NCT01889355
• Lead Sponsor: AgaMatrix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Study Start: 2014-01
• Primary Completion: 2014-02
• Status Verified: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2018-07-10
• Results First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced meter feature usability	AgaMatrix Blood Glucose Monitor	Home diabetes monitoring by patient using provided blood glucose monitoring system.

Primary Outcome Measures

Name	Time	Method
Enhanced Meter Feature Usability	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).

Trial Locations

Locations (1)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States