User Performance Evaluation for DARIO™ BGMS

LabStyle Innovations

Status: Completed

Conditions: Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02357043

CP-0002

Details and patient eligibility

About

The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.

Full description

Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.

Enrollment: 368 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has Type I or Type II diabetes
2. Subject speaks and reads English proficiently
3. Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
4. Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study).

Exclusion criteria

1. Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
2. Subject is critically ill
3. Subject has an impairment that prevents him/her to follow the study procedures
4. Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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368 participants in 1 patient group

Dario Blood Glucose Monitoring System

Experimental group

Description:

Subject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).

Treatment:

Device: Dario Blood Glucose Monitoring System

Device: YSI