Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

Diabetes Mellitus Clinical Trial

Official title:

Dario Blood Glucose Monitoring System - Android Devices User Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910674
• Other study ID #: CP-0004
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: March 2021
• Source: LabStyle Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

Description:

The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject has Type 1 or Type II diabetes

• Subject speaks and reads English proficiently

• 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:

• Subject has medical training or works in the field of blood glucose monitoring systems.

• Subject is critically ill.

• Subject has an impairment that prevents him/her from following the study procedures.

• Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

• Hematocrit levels outside the range of 20%-60%.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Dario Blood Glucose Monitoring System
Accuracy with usability assessment

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

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 of Glucose Concentrations (%)	Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations < 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL.; The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus.	1 Day
Primary	Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"	Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful.; Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS?	1 Day
Primary	Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"	Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy.; An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time?	1 Day
Primary	Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"	The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS?; 100% of subjects (102 of 102) answered "Yes" to this question.	1 Day