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Completed

NCT Number: NCT02352298

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

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.

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Key information

Conditions

Diabetes 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

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age of subject is 18 years or older
  • Able to speak and read English

Exclusion criteria

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

Treatment and study plan

Dario Blood Glucose Monitoring System

Device

Fingerstick to obtain blood sample for analysis with the Dario BGMS

YSI Analyzer

Device

Fingerstick to obtain blood sample for analysis with YSI

Primary outcomes

  1. Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)

    Time frame: 6 seconds

    Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 2, 2015
Registry last updated
Jun 9, 2017

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.

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