Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

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).

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Glucose Monitoring System Altitude Performance

Device

Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Primary outcomes

Number of Successful Glucose Readings

Time frame: One day

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).

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Official study title

Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Sep 27, 2016
Registry last updated: Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed