NCT01756274

Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 30 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Contour® NEXT BGMS	Lab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
DEVICE	Contour® PLUS BGMS	Lab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
DEVICE	Contour® Next EZ BGMS	Lab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-12-25
• Last updated: 2017-02-15
• Results posted: 2014-04-09

Locations

1 site across 1 country: United States