Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

LabStyle Innovations

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Blood Glucose Monitoring System Altitude Performance

Study type: Interventional

Funder types: Industry

Identifiers

NCT02916563

CP-0006

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Altitude

Experimental group

Description:

Single arm study Blood Glucose Monitoring System Altitude Performance

Treatment:

Device: Blood Glucose Monitoring System Altitude Performance