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Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

NCT ID: NCT02916563

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Altitude

Single arm study Blood Glucose Monitoring System Altitude Performance

Group Type EXPERIMENTAL

Blood Glucose Monitoring System Altitude Performance

Intervention Type DEVICE

Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Interventions

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Blood Glucose Monitoring System Altitude Performance

Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LabStyle Innovations Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barbara Davis Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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CP-0006

Identifier Type: -

Identifier Source: org_study_id