NCT02352298

Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

Protocol for the Evaluation of Dario™ Blood Glucose Monitor (BGMS) Performance at Elevated Altitude

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.

Detailed description

The study will be performed with 50 fresh capillary blood samples, collected by fingerstick using Dario single use lancet. Additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the YSI 2300 STAT Plus analyzer. Additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Dario Blood Glucose Monitoring System	Fingerstick to obtain blood sample for analysis with the Dario BGMS
DEVICE	YSI Analyzer	Fingerstick to obtain blood sample for analysis with YSI

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-02-02
• Last updated: 2017-06-09
• Results posted: 2017-06-09

Locations

1 site across 1 country: United States