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Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

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ClinicalTrials.gov Identifier: NCT02916563
Recruitment Status : Completed
First Posted : September 27, 2016
Results First Posted : October 6, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
LabStyle Innovations Ltd.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Blood Glucose Monitoring System Altitude Performance Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation
Study Start Date : July 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Altitude
Single arm study Blood Glucose Monitoring System Altitude Performance
 Device: Blood Glucose Monitoring System Altitude Performance
Performance as assessed against a reference method at an altitude of approximately 10,000 feet.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916563


Locations
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United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
LabStyle Innovations Ltd.
More Information
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Responsible Party: LabStyle Innovations Ltd.
ClinicalTrials.gov Identifier: NCT02916563    
Other Study ID Numbers: CP-0006
First Posted: September 27, 2016    Key Record Dates
Results First Posted: October 6, 2020
Last Update Posted: November 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No