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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352298
• Other study ID #: CP-0003
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: March 9, 2015
• Start date: February 2015
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: LabStyle Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Dario Blood Glucose Monitoring System
Fingerstick to obtain blood sample for analysis with the Dario BGMS
• YSI Analyzer
Fingerstick to obtain blood sample for analysis with YSI

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	Accuracy of the Dario™ Blood Glucose Monitor (BGMS) at elevated altitude by comparing the blood glucose level (BGL) results measured by Dario™ BGMS vs. BGL results measured by YSI		8 hrs.	No