NCT00797563

Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.

Detailed description

The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-11-25
• Last updated: 2016-02-29
• Results posted: 2009-12-22

Locations

1 site across 1 country: United States