Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Blood Glucose Monitoring System Altitude Performance

• Registration Number: NCT02916563
• Lead Sponsor: LabStyle Innovations Ltd.

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Results First Submitted: 2020-08-19
• Results First Submitted QC: 2020-09-14
• Status Verified: 2020-10
• Results First Posted: 2020-10-06
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Altitude	Blood Glucose Monitoring System Altitude Performance	Single arm study Blood Glucose Monitoring System Altitude Performance

Primary Outcome Measures

Name	Time	Method
Number of Successful Glucose Readings	One day	The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).

Trial Locations

Locations (1)

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