NCT02910674

Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

Dario Blood Glucose Monitoring System - Android Devices User Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: All
• Age: 13 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

Detailed description

The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Dario Blood Glucose Monitoring System	Accuracy with usability assessment

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-09-22
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

1 site across 1 country: United States