Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Dario Blood Glucose Monitoring System
- Registration Number
- NCT02910674
- Lead Sponsor
- LabStyle Innovations Ltd.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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)
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description One Arm Dario Blood Glucose Monitoring System This is a comparative diagnostic study, no interventional actions are being taken.
- Primary Outcome Measures
Name Time Method Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?" 1 Day 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?Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?" 1 Day 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.Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS" 1 Day 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?Accuracy of Glucose Concentrations (%) 1 Day 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Barbara Davis Center
🇺🇸Aurora, Colorado, United States