User Performance Evaluation for DARIO™ BGMS

Diabetes Clinical Trial

Official title:

User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357043
• Other study ID #: CP-0002
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2016
• Source: LabStyle Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Dario Blood Glucose Monitoring System
Finger-stick obtained with BGMS
• YSI
Finger-stick sample obtained by nurse/technician to be tested with YSI

Locations

Country	Name	City	State
United States	Remington-Davis, Inc.	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
LabStyle Innovations Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician	Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)	5 minutes