NCT01135771

Performance Study Using the OptiScanner on Healthy Diabetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results will be compared to the OptiScanner's glucose measurement.

Conditions

• Diabetes

Interventions

Type	Name	Description
OTHER	glucose and insulin IV to alter blood glucose

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-06-03
• Last updated: 2010-06-03

Locations

1 site across 1 country: Germany