NCT02916563

Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).

Detailed description

This study will be a non-randomized study conducted to assess the accuracy and performance of the Dario Blood Glucose Monitoring System at an elevated altitude. 50 subjects will be enrolled in this study. Participation includes a 15-20 minute visit to the clinical site where they will be consented. The participant will then receive a fingerstick to obtain capillary blood used to test the performance of the BGMS and to obtain a comparative glucose measurement on the reference method, the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Blood Glucose Monitoring System Altitude Performance	Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-09-27
• Last updated: 2020-11-19
• Results posted: 2020-10-06

Locations

1 site across 1 country: United States