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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Dario Blood Glucose Monitoring System; Device: YSI Analyzer

• Registration Number: NCT02352298
• Lead Sponsor: LabStyle Innovations Ltd.

Brief 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.

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 Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-27
• Study Start: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Posted: 2015-02-02
• Results First Submitted: 2015-03-19
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-05
• Last Update Submitted: 2017-05-05
• Results First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dario Blood Glucose Monitoring System	Dario Blood Glucose Monitoring System	Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
YSI STAT	YSI Analyzer	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States