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

May 5, 2017 updated by: LabStyle Innovations Ltd.

Protocol for the Evaluation of Dario™ Blood Glucose Monitor (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dario Blood Glucose Monitoring System
Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
Device: Dario Blood Glucose Monitoring System
Fingerstick to obtain blood sample for analysis with the Dario BGMS
Active Comparator: YSI STAT
Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System
Device: YSI Analyzer
Fingerstick to obtain blood sample for analysis with YSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LabStyle Innovations Ltd.

Investigators

  • Study Chair: Christie Beatson, Barbara Davis Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CP-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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