Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

Diabetes Mellitus Clinical Trial

Official title:

Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916563
• Other study ID #: CP-0006
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2020
• Source: LabStyle Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to speak and read English

Exclusion Criteria:

• Pregnant

• Has any condition that the principle investigator believes may interfere in the subject's participation in the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Blood Glucose Monitoring System Altitude Performance
Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
LabStyle Innovations Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Successful Glucose Readings	The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).	One day