NCT00798486

Evaluation of the A1CNow+ Test Kit

In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.

Detailed description

The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	A1C Test Kit	Subjects tested 3 times with A1C test kits. Two tests were performed by the subject and the third test was performed by a healthcare professional (HCP). All results were compared to results from a laboratory glucose analyzer (TOSOH).

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-11-26
• Last updated: 2016-02-29
• Results posted: 2010-03-09

Locations

2 sites across 1 country: United States