NCT00797212

A New Glucose Meter With Alternative Site Testing

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (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 blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

Detailed description

The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Apollo Blood Glucose Monitoring System	Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-11-25
• Last updated: 2016-11-03
• Results posted: 2009-12-14

Locations

1 site across 1 country: United States