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

LabStyle Innovations

Status: Completed

Conditions: Diabetes

Treatments: Device: Dario Blood Glucose Monitoring System; Device: YSI Analyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02352298

CP-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Dario Blood Glucose Monitoring System

Experimental group

Description:

Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System

Treatment:

Device: Dario Blood Glucose Monitoring System

YSI STAT

Active Comparator group

Description:

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

Treatment:

Device: YSI Analyzer